Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-25 @ 7:38 PM
Study NCT ID:
NCT00281632
Status:
COMPLETED
Last Update Posted:
2018-09-17
First Post:
2006-01-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Phase II, Open-Label Study Evaluating the Effect Of GW786034 In Subjects With Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D005185', 'term': 'Fallopian Tube Neoplasms'}, {'id': 'D000077216', 'term': 'Carcinoma, Ovarian Epithelial'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D005184', 'term': 'Fallopian Tube Diseases'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C516667', 'term': 'pazopanib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Pazopanib 800 mg', 'description': '800 milligrams (mg) pazopanib administered orally once daily', 'otherNumAtRisk': 36, 'otherNumAffected': 35, 'seriousNumAtRisk': 36, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal distensions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Edema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood alkaline phosphastase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hair color changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperkeratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nail disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Petechiae', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 11}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lymph node pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Breast cancer situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Best Biochemical Response (Cancer Antigen [CA-125])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pazopanib 800 mg', 'description': '800 milligrams (mg) pazopanib administered orally once daily'}], 'classes': [{'title': '50% Response Normalized', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': '50% Response Non-Normalized', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Stable Disease', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}]}]}, {'title': 'Progressive Disease', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Unconfirmed Progressive Disease', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Reponse rate', 'ciPctValue': '95', 'paramValue': '31', 'ciLowerLimit': '16.3', 'ciUpperLimit': '48.1', 'estimateComment': '50% Response Rate (Normalized and Non-Normalized)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to response (up to 3 years)', 'description': 'Defined using modified Gynecologic Cancer Intergroup (GCIG) criteria: 50% response=≥50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments) then confirmed after 21 days. 50% CA-125 response was normalized (CA-125 \\>21U/mL) or non-normalized (CA-125≤1U/mL). Progressive disease (PD) =CA-125 increase ≥100% from nadir (nadir \\>21U/mL) or ≥42U/mL (nadir ≤21U/mL); nadir was lowest CA-125. PD was confirmed after 21 days; otherwise=unconfirmed PD. Stable disease=scenarios that do not meet 50% response or PD. CA-125 response rate was defined as % of participants with 50% response.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants'}, {'type': 'SECONDARY', 'title': 'Time to Biochemical Response (CA-125)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pazopanib 800 mg', 'description': '800 milligrams (mg) pazopanib administered orally once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000', 'lowerLimit': '27', 'upperLimit': '57'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to response (up to 3 years)', 'description': 'Time to biochemical response was calculated as the date pazopanib was first dosed to the date CA-125 was first reduced by 50% or greater. The reduction in CA-125 of 50% or greater was to be confirmed by a repeat measurement (no earlier than 21 days after initial evaluation documenting decrement). This was calculated for all participants with confirmed CA-125 50% reduction.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with confirmed CA-125 50% reduction'}, {'type': 'SECONDARY', 'title': 'Duration of Biochemical Response (CA-125)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pazopanib 800 mg', 'description': '800 milligrams (mg) pazopanib administered orally once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000', 'lowerLimit': '58.0', 'upperLimit': '190.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to response (up to 3 years)', 'description': 'Calculated as the date of confirmed first 50% or greater reduction in CA-125 to date of documented progression by clinical, radiographic, or biochemical criteria, whichever occurred earliest. This was calculated for all participants with confirmed CA-125 50% reduction.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with confirmed CA-125 50% reduction'}, {'type': 'SECONDARY', 'title': 'CA-125 Doubling Time Prior to and During Treatment With Pazopanib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Study Arm'}], 'timeFrame': 'Baseline to doubling of CA-125 (up to 3 years)', 'description': 'CA-125 doubling time is defined as the time for CA-125 to double from baseline value. This measure was not reported, as no participants had a post-baseline CA-125 that was double the baseline value. Therefore, the data did not warrant a report.', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with confirmed CA-125 50% reduction'}, {'type': 'SECONDARY', 'title': 'Overall Response and Stable Disease (SD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pazopanib 800 mg With Measurable Disease', 'description': 'Participants with measureable disease at baseline who were administered 800 milligrams (mg) pazopanib administered orally once daily'}, {'id': 'OG001', 'title': 'Pazopanib 800 mg Without Measurable Disease', 'description': 'Participants without measureable disease at baseline who were administered 800 milligrams (mg) pazopanib administered orally once daily.'}, {'id': 'OG002', 'title': 'Pazopanib 800 mg All', 'description': 'All participants administered 800 milligrams (mg) pazopanib administered orally once daily'}], 'classes': [{'title': 'Complete Reponse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5.3', 'groupId': 'OG001'}, {'value': '2.8', 'groupId': 'OG002'}]}]}, {'title': 'Partial Response', 'categories': [{'measurements': [{'value': '17.6', 'groupId': 'OG000'}, {'value': '15.8', 'groupId': 'OG001'}, {'value': '16.7', 'groupId': 'OG002'}]}]}, {'title': 'Stable Disease', 'categories': [{'measurements': [{'value': '17.6', 'groupId': 'OG000'}, {'value': '26.3', 'groupId': 'OG001'}, {'value': '22.2', 'groupId': 'OG002'}]}]}, {'title': 'Progressive Disease', 'categories': [{'measurements': [{'value': '64.7', 'groupId': 'OG000'}, {'value': '47.4', 'groupId': 'OG001'}, {'value': '55.6', 'groupId': 'OG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5.3', 'groupId': 'OG001'}, {'value': '2.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Response rate', 'ciPctValue': '95', 'paramValue': '17.6', 'ciLowerLimit': '3.8', 'ciUpperLimit': '43.4', 'estimateComment': 'Response rate (CR+PR)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG001'], 'paramType': 'Response rate', 'ciPctValue': '95', 'paramValue': '21.1', 'ciLowerLimit': '6.1', 'ciUpperLimit': '45.6', 'estimateComment': 'Response rate (CR+PR)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Response rate', 'ciPctValue': '95', 'paramValue': '19.4', 'ciLowerLimit': '8.2', 'ciUpperLimit': '36.0', 'estimateComment': 'Response rate (CR+PR)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to response (up to 3 years)', 'description': 'Overall response and stable disease (SD) are based on biochemical, radiographic, and clinical assessments according to the modified criteria of Gynecologic Cancer Intergroup (GCIG) (see primary outcome). Response is presented as the percentage of participants with the given response.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants'}, {'type': 'SECONDARY', 'title': 'Median Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pazopanib 800 mg Responders', 'description': '800 milligrams (mg) pazopanib administered orally once daily Responders'}, {'id': 'OG001', 'title': 'Pazopanib 800 mg Non-Responders', 'description': '800 milligrams (mg) pazopanib administered orally once daily Non-Responders'}, {'id': 'OG002', 'title': 'Pazopanib 800 mg All', 'description': '800 milligrams (mg) pazopanib administered orally once daily All participants'}], 'classes': [{'categories': [{'measurements': [{'value': '168', 'groupId': 'OG000', 'lowerLimit': '84.0', 'upperLimit': '217.0'}, {'value': '57', 'groupId': 'OG001', 'lowerLimit': '51.0', 'upperLimit': '85.0'}, {'value': '84', 'groupId': 'OG002', 'lowerLimit': '57.0', 'upperLimit': '141.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Date of the first dose of study drug to the date of documented and confirmed progression by clinical, radiographic, or biochemical criteria, whichever occurred earliest, or to date of death due to any causes (up to 2 years)', 'description': 'Progression-free survival analysis was performed on all participants and then stratified by CA-125 response status (having confirmed 50% reduction or not). PFS was defined as the time from the date of the first dose of study drug to the date of documented and confirmed progression by clinical, radiographic, or biochemical criteria, whichever occurred earliest, or to date of death due to any causes.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with PFS'}, {'type': 'SECONDARY', 'title': 'Overall Tumor Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pazopanib 800 mg', 'description': '800 milligrams (mg) pazopanib administered orally once daily'}], 'classes': [{'title': 'Complete Response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Partial Response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Stable Disease', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Progressive Disease', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to response (up to 3 years)', 'description': 'Overall tumor response following daily administration of pazopanib was defined using radiographic assessments based on Response Evaluation Criteria for Solid Tumors (RECIST) criteria for subjects with measurable disease at baseline.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pazopanib 800 mg', 'description': '800 milligrams (mg) pazopanib administered orally once daily'}], 'classes': [{'title': 'BL, 50-89 mmHg; shift to post-BL, <50 mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'BL, 50-89 mmHg; shift to post-BL, 50-89 mmHg', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'BL, 50-89 mmHg; shift to post-BL, 90-109 mmHg', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'BL, 50-89 mmHg; shift to post-BL, >=109 mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'BL, 90-109 mmHg; shift to post-BL, <50 mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'BL, 90-109 mmHg; shift to post-BL, 50-89 mmHg', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'BL, 90-109 mmHg; shift to post-BL, 90-109 mmHg', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'BL, 90-109 mmHg; shift to post-BL, >=109 mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to response (up to 3 years)', 'description': 'Summary of shifts in diastolic blood pressure from baseline to the maximum change in the study. mmHg, millimeters of mercury.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants. Data are presented for only those participants who provided measurements at baseline and maximum shift post-baseline.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pazopanib 800 mg', 'description': ': 800 milligrams (mg) pazopanib administered orally once daily'}], 'classes': [{'title': 'BL, 90-139 mmHg; shift to post-BL, <90 mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'BL, 90-139 mmHg; shift to post-BL, 90-139 mmHg', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'BL, 90-139 mmHg; shift to post-BL, 140-169 mmHg', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'BL, 90-139 mmHg; shift to post-BL, >=170 mmHg', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'BL, 140-169 mmHg; shift to post-BL, <90 mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'BL, 140-169 mmHg; shift to post-BL, 90-139 mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'BL, 140-169 mmHg; shift to post-BL, 140-169 mmHg', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'BL, 140-169 mmHg; shift to post-BL, >=170 mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'BL, >=170 mmHg; shift to post-BL, 90-139 mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'BL, >=170 mmHg; shift to post-BL, 140-169 mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'BL, >=170 mmHg; shift to post-BL, >=170 mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to response (up to 3 years)', 'description': 'Summary of shifts in systolic blood pressure from baseline to the maximum change in the study. mmHg, millimeters of mercury.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants. Data are presented for only those participants who provided measurements at baseline and maximum shift post-baseline.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pazopanib 800 mg', 'description': '800 milligrams (mg) pazopanib administered orally once daily'}], 'classes': [{'title': 'BL, 44-100 bpm; shift to post-BL, <44 bpm', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'BL, 44-100 bpm; shift to post-BL, 44-100 bpm', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'BL, 44-100 bpm; shift to post-BL, 101-120 bpm', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'BL, 44-100 bpm; shift to post-BL, >120 bpm', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'BL, 101-120 bpm; shift to post-BL, <44 bpm', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'BL, 101-120 bpm; shift to post-BL, 44-100 bpm', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'BL, 101-120 bpm; shift to post-BL, 101-120 bpm', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'BL, 101-120 bpm; shift to post-BL, >120 bpm', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to response (up to 3 years)', 'description': 'Summary of shifts in heart rate from baseline to the maximum change in the study. bpm, beats per minute.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Response in Albumin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pazopanib 800 mg', 'description': '800 milligrams (mg) pazopanib administered orally once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.5', 'spread': '8.82', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to response (up to 3 years)', 'description': 'Change from baseline is calculated as the value at the time of response minus the value at Baseline.', 'unitOfMeasure': 'grams per liter (g/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Response in Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pazopanib 800 mg', 'description': '800 milligrams (mg) pazopanib administered orally once daily'}], 'classes': [{'title': 'Alkaline phosphatase, n=29', 'categories': [{'measurements': [{'value': '7.3', 'spread': '27.76', 'groupId': 'OG000'}]}]}, {'title': 'Alanine aminotransferase, n=29', 'categories': [{'measurements': [{'value': '13.0', 'spread': '23.25', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate aminotransferase, n=28', 'categories': [{'measurements': [{'value': '7.1', 'spread': '12.65', 'groupId': 'OG000'}]}]}, {'title': 'Lactate dehydrogenase, n=21', 'categories': [{'measurements': [{'value': '4.62', 'spread': '29.630', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to response (up to 3 years)', 'description': 'Change from baseline is calculated as the value at the time of response minus the value at Baseline.', 'unitOfMeasure': 'International Units per liter (IU/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Response in Amylase and Lipase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pazopanib 800 mg', 'description': '800 milligrams (mg) pazopanib administered orally once daily'}], 'classes': [{'title': 'Amylase', 'categories': [{'measurements': [{'value': '7.32', 'spread': '31.038', 'groupId': 'OG000'}]}]}, {'title': 'Lipase', 'categories': [{'measurements': [{'value': '7.273', 'spread': '24.994', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to response (up to 3 years)', 'description': 'Change from baseline is calculated as the value at the time of response minus the value at Baseline.', 'unitOfMeasure': 'Units per liter (U/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Response in Total Bilirubin and Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pazopanib 800 mg', 'description': '800 milligrams (mg) pazopanib administered orally once daily'}], 'classes': [{'title': 'Total bilirubin', 'categories': [{'measurements': [{'value': '0.715', 'spread': '2.7039', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine', 'categories': [{'measurements': [{'value': '1.37', 'spread': '8.846', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to response (up to 3 years)', 'description': 'Change from baseline is calculated as the value at the time of response minus the value at Baseline.', 'unitOfMeasure': 'micromoles per liter (umol/l)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Response in Calcium, Glucose, Potassium, Sodium, and Urea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pazopanib 800 mg', 'description': '800 milligrams (mg) pazopanib administered orally once daily'}], 'classes': [{'title': 'Calcium, n=29', 'categories': [{'measurements': [{'value': '-0.038', 'spread': '0.1034', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, n=28', 'categories': [{'measurements': [{'value': '0.302', 'spread': '1.7285', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, n=28', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.553', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, n=29', 'categories': [{'measurements': [{'value': '0.1', 'spread': '2.85', 'groupId': 'OG000'}]}]}, {'title': 'Urea, n=29', 'categories': [{'measurements': [{'value': '-0.227', 'spread': '1.3410', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to response (up to 3 years)', 'description': 'Change from baseline is calculated as the value at the time of response minus the value at Baseline.', 'unitOfMeasure': 'millimoles per liter (mmol/l)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Response in Thyroxine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pazopanib 800 mg', 'description': '800 milligrams (mg) pazopanib administered orally once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.003', 'spread': '0.0018', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to response (up to 3 years)', 'description': 'Change from baseline is calculated as the value at the time of response minus the value at Baseline.', 'unitOfMeasure': 'nanomoles per liter (nmol/l)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Response in Thyroid Stimulating Hormone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pazopanib 800 mg', 'description': '800 milligrams (mg) pazopanib administered orally once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.87', 'spread': '1.693', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to response (up to 3 years)', 'description': 'Change from baseline is calculated as the value at the time of response minus the value at Baseline.', 'unitOfMeasure': 'milliunits per liter (MU/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Response in Hemoglobin and Hematocrit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pazopanib 800 mg', 'description': '800 milligrams (mg) pazopanib administered orally once daily'}], 'classes': [{'title': 'Hemoglobin', 'categories': [{'measurements': [{'value': '-0.53', 'spread': '13.952', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit', 'categories': [{'measurements': [{'value': '-0.00', 'spread': '0.048', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to response (up to 3 years)', 'description': 'Change from baseline is calculated as the value at the time of response minus the value at Baseline.', 'unitOfMeasure': 'g/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants. Data are presented for only those participants who provided hematology measurements at both baseline and the time of response.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Response in Lymphocytes, Neutrophils, Platelet Count, and White Blood Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pazopanib 800 mg', 'description': '800 milligrams (mg) pazopanib administered orally once daily'}], 'classes': [{'title': 'Lymphocytes', 'categories': [{'measurements': [{'value': '0.32', 'spread': '2.191', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils', 'categories': [{'measurements': [{'value': '-0.12', 'spread': '2.276', 'groupId': 'OG000'}]}]}, {'title': 'Platelet count', 'categories': [{'measurements': [{'value': '-9.93', 'spread': '75.487', 'groupId': 'OG000'}]}]}, {'title': 'White blood cell count', 'categories': [{'measurements': [{'value': '-0.28', 'spread': '2.373', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to response (up to 3 years)', 'description': 'Change from baseline is calculated as the value at the time of response minus the value at Baseline.', 'unitOfMeasure': 'giga (10^9) per liter (GI/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants. Data are presented for only those participants who provided hematology measurements at both baseline and the time of response.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pazopanib 800 mg', 'description': '800 milligrams (mg) pazopanib administered orally once daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Three participants were ongoing in the study at the time of the data cut-off (30 Apr 2008).', 'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Ongoing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Pazopanib 800 mg', 'description': '800 milligrams (mg) pazopanib administered orally once daily'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.9', 'spread': '11.24', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian - South East Asian Heritage', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'White - White/Caucasian/European Heritage', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': True}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-13', 'studyFirstSubmitDate': '2006-01-23', 'resultsFirstSubmitDate': '2009-11-25', 'studyFirstSubmitQcDate': '2006-01-23', 'lastUpdatePostDateStruct': {'date': '2018-09-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-01-03', 'studyFirstPostDateStruct': {'date': '2006-01-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best Biochemical Response (Cancer Antigen [CA-125])', 'timeFrame': 'Baseline to response (up to 3 years)', 'description': 'Defined using modified Gynecologic Cancer Intergroup (GCIG) criteria: 50% response=≥50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments) then confirmed after 21 days. 50% CA-125 response was normalized (CA-125 \\>21U/mL) or non-normalized (CA-125≤1U/mL). Progressive disease (PD) =CA-125 increase ≥100% from nadir (nadir \\>21U/mL) or ≥42U/mL (nadir ≤21U/mL); nadir was lowest CA-125. PD was confirmed after 21 days; otherwise=unconfirmed PD. Stable disease=scenarios that do not meet 50% response or PD. CA-125 response rate was defined as % of participants with 50% response.'}], 'secondaryOutcomes': [{'measure': 'Time to Biochemical Response (CA-125)', 'timeFrame': 'Baseline to response (up to 3 years)', 'description': 'Time to biochemical response was calculated as the date pazopanib was first dosed to the date CA-125 was first reduced by 50% or greater. The reduction in CA-125 of 50% or greater was to be confirmed by a repeat measurement (no earlier than 21 days after initial evaluation documenting decrement). This was calculated for all participants with confirmed CA-125 50% reduction.'}, {'measure': 'Duration of Biochemical Response (CA-125)', 'timeFrame': 'Baseline to response (up to 3 years)', 'description': 'Calculated as the date of confirmed first 50% or greater reduction in CA-125 to date of documented progression by clinical, radiographic, or biochemical criteria, whichever occurred earliest. This was calculated for all participants with confirmed CA-125 50% reduction.'}, {'measure': 'CA-125 Doubling Time Prior to and During Treatment With Pazopanib', 'timeFrame': 'Baseline to doubling of CA-125 (up to 3 years)', 'description': 'CA-125 doubling time is defined as the time for CA-125 to double from baseline value. This measure was not reported, as no participants had a post-baseline CA-125 that was double the baseline value. Therefore, the data did not warrant a report.'}, {'measure': 'Overall Response and Stable Disease (SD)', 'timeFrame': 'Baseline to response (up to 3 years)', 'description': 'Overall response and stable disease (SD) are based on biochemical, radiographic, and clinical assessments according to the modified criteria of Gynecologic Cancer Intergroup (GCIG) (see primary outcome). Response is presented as the percentage of participants with the given response.'}, {'measure': 'Median Progression-free Survival (PFS)', 'timeFrame': 'Date of the first dose of study drug to the date of documented and confirmed progression by clinical, radiographic, or biochemical criteria, whichever occurred earliest, or to date of death due to any causes (up to 2 years)', 'description': 'Progression-free survival analysis was performed on all participants and then stratified by CA-125 response status (having confirmed 50% reduction or not). PFS was defined as the time from the date of the first dose of study drug to the date of documented and confirmed progression by clinical, radiographic, or biochemical criteria, whichever occurred earliest, or to date of death due to any causes.'}, {'measure': 'Overall Tumor Response', 'timeFrame': 'Baseline to response (up to 3 years)', 'description': 'Overall tumor response following daily administration of pazopanib was defined using radiographic assessments based on Response Evaluation Criteria for Solid Tumors (RECIST) criteria for subjects with measurable disease at baseline.'}, {'measure': 'Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Diastolic Blood Pressure', 'timeFrame': 'Baseline to response (up to 3 years)', 'description': 'Summary of shifts in diastolic blood pressure from baseline to the maximum change in the study. mmHg, millimeters of mercury.'}, {'measure': 'Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Systolic Blood Pressure', 'timeFrame': 'Baseline to response (up to 3 years)', 'description': 'Summary of shifts in systolic blood pressure from baseline to the maximum change in the study. mmHg, millimeters of mercury.'}, {'measure': 'Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Heart Rate', 'timeFrame': 'Baseline to response (up to 3 years)', 'description': 'Summary of shifts in heart rate from baseline to the maximum change in the study. bpm, beats per minute.'}, {'measure': 'Mean Change From Baseline to Response in Albumin', 'timeFrame': 'Baseline to response (up to 3 years)', 'description': 'Change from baseline is calculated as the value at the time of response minus the value at Baseline.'}, {'measure': 'Mean Change From Baseline to Response in Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase', 'timeFrame': 'Baseline to response (up to 3 years)', 'description': 'Change from baseline is calculated as the value at the time of response minus the value at Baseline.'}, {'measure': 'Mean Change From Baseline to Response in Amylase and Lipase', 'timeFrame': 'Baseline to response (up to 3 years)', 'description': 'Change from baseline is calculated as the value at the time of response minus the value at Baseline.'}, {'measure': 'Mean Change From Baseline to Response in Total Bilirubin and Creatinine', 'timeFrame': 'Baseline to response (up to 3 years)', 'description': 'Change from baseline is calculated as the value at the time of response minus the value at Baseline.'}, {'measure': 'Mean Change From Baseline to Response in Calcium, Glucose, Potassium, Sodium, and Urea', 'timeFrame': 'Baseline to response (up to 3 years)', 'description': 'Change from baseline is calculated as the value at the time of response minus the value at Baseline.'}, {'measure': 'Mean Change From Baseline to Response in Thyroxine', 'timeFrame': 'Baseline to response (up to 3 years)', 'description': 'Change from baseline is calculated as the value at the time of response minus the value at Baseline.'}, {'measure': 'Mean Change From Baseline to Response in Thyroid Stimulating Hormone', 'timeFrame': 'Baseline to response (up to 3 years)', 'description': 'Change from baseline is calculated as the value at the time of response minus the value at Baseline.'}, {'measure': 'Mean Change From Baseline to Response in Hemoglobin and Hematocrit', 'timeFrame': 'Baseline to response (up to 3 years)', 'description': 'Change from baseline is calculated as the value at the time of response minus the value at Baseline.'}, {'measure': 'Mean Change From Baseline to Response in Lymphocytes, Neutrophils, Platelet Count, and White Blood Count', 'timeFrame': 'Baseline to response (up to 3 years)', 'description': 'Change from baseline is calculated as the value at the time of response minus the value at Baseline.'}]}, 'conditionsModule': {'keywords': ['Pazopanib', 'Fallopian tube cancer', 'Ovarian epithelial cancer', 'Peritoneal cancer'], 'conditions': ['Peritoneal Cancer', 'Ovarian Cancer', 'Neoplasms, Ovarian', 'Fallopian Tube Cancer']}, 'referencesModule': {'references': [{'pmid': '20584542', 'type': 'BACKGROUND', 'citation': 'Friedlander M, Hancock KC, Rischin D, Messing MJ, Stringer CA, Matthys GM, Ma B, Hodge JP, Lager JJ. A Phase II, open-label study evaluating pazopanib in patients with recurrent ovarian cancer. Gynecol Oncol. 2010 Oct;119(1):32-7. doi: 10.1016/j.ygyno.2010.05.033. Epub 2010 Jun 27.'}]}, 'descriptionModule': {'briefSummary': 'This study was designed to find out how effective and safe GW786034, is in the treatment of epithelial ovarian, fallopian tube, or primary peritoneal cancer that has not responded to standard treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Confirmed diagnosis of epithelial ovarian, fallopian tube or primary peritoneal carcinoma.\n* Has received one prior platinum-based chemotherapy regimen(cisplatin,carboplatin, or oxaliplatin).\n* Has psychological, familial, sociological or geographical condition that does not permit compliance with the protocol.\n* Is on a specifically prohibited medication or requires these medications during treatment with GW786034.\n\nExclusion criteria:\n\n* Has had any surgery, chemotherapy, hormonal therapy, biologic, immunotherapy, or radiotherapy with in the last 28 days and has not recovered from such prior therapy.\n* Poorly controlled hypertension(systolic 140mmHg or higher or Diastolic 90mmHg or higher).\n* Currently taking warfarin.\n* Low molecular weight heparin and low-dose warfarin(1mg per day)is permitted.'}, 'identificationModule': {'nctId': 'NCT00281632', 'briefTitle': 'A Phase II, Open-Label Study Evaluating the Effect Of GW786034 In Subjects With Ovarian Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'This Study is a Non-randomized, Open-label, Multi-center Phase II Study of GW786034 to Evaluate the Administration of Oral GW786034 in Subjects With Ovarian Cancer.', 'orgStudyIdInfo': {'id': '104450'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pazopanib', 'description': '800 mg GW786034 administered orally on a daily basis.', 'interventionNames': ['Drug: GW786034']}], 'interventions': [{'name': 'GW786034', 'type': 'DRUG', 'description': '800 mg GW786034 administered orally on a daily basis.', 'armGroupLabels': ['Pazopanib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '76022', 'city': 'Bedford', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.84402, 'lon': -97.14307}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '2031', 'city': 'Randwick', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -33.91439, 'lon': 151.24895}}, {'zip': '4029', 'city': 'Herston', 'state': 'Queensland', 'country': 'Australia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -27.44453, 'lon': 153.01852}}, {'zip': '3084', 'city': 'Melbourne', 'country': 'Australia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '119074', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '229899', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'GSK Clinical Trials, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}