Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-06 @ 4:30 AM
Study NCT ID:
NCT00475956
Status:
COMPLETED
Last Update Posted:
2010-04-15
First Post:
2007-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerability Study of AZD2171 in Combination With AZD0530 in Patients With Advanced Solid Tumours
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D018281', 'term': 'Cholangiocarcinoma'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D002822', 'term': 'Choriocarcinoma'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D014328', 'term': 'Trophoblastic Neoplasms'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D011252', 'term': 'Pregnancy Complications, Neoplastic'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female 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': 'D010182', 'term': 'Pancreatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C500926', 'term': 'cediranib'}, {'id': 'C515233', 'term': 'saracatinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-04-14', 'studyFirstSubmitDate': '2007-05-18', 'studyFirstSubmitQcDate': '2007-05-18', 'lastUpdatePostDateStruct': {'date': '2010-04-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the safety and tolerability of ascending daily oral doses of AZD2171 when co-administered with AZD0530 to patients with advanced solid tumours by assessment of AEs, vital signs, HRCT Scans, clin chem, haematology, urinalysis, ECG and phys exam', 'timeFrame': 'assessed at each visit'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (PK) of AZD2171 alone and in combination with AZD0530', 'timeFrame': 'assessed at each visit'}, {'measure': 'Safety and efficacy', 'timeFrame': 'assessed at each visit'}, {'measure': 'Genetic variation of pathways targeted by AZD2171 and AZD0530', 'timeFrame': 'assessed during study'}]}, 'conditionsModule': {'keywords': ['Cancer', 'Tumour', 'Advanced Solid Tumour', 'Lung Cancer', 'Breast Cancer', 'Cholangiocarcinoma', 'Colon Cancer', 'Gastric Cancer', 'Choriocarcinoma', 'Liver Cancer', 'Myeloma', 'Ovarian Cancer', 'Pancreatic Cancer', 'Peritoneal Cancer'], 'conditions': ['Neoplasms']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine if the maximum tolerated doses of AZD2171, in combination with AZD0530, in treating patients with advanced solid tumours are safe, tolerable and efficacious.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written consent\n* Cancer diagnosis \\& stage\n* Patients for whom no standard therapy exists\n* World Health Organization (WHO) performance status 0-2\n* One or more measurable lesions\n\nExclusion Criteria:\n\n* Prostate cancer\n* Untreated unstable brain or meningeal metastases\n* Specific laboratory ranges\n* Pregnant or breast-feeding women\n* Any evidence of severe or uncontrolled diseases\n* Participation in other trials within 30 days'}, 'identificationModule': {'nctId': 'NCT00475956', 'briefTitle': 'Safety and Tolerability Study of AZD2171 in Combination With AZD0530 in Patients With Advanced Solid Tumours', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Phase I, Open-Label Study To Assess the Safety, Tolerability and Pharmacokinetics of Daily Oral Doses of Cediranib (RECENTIN™;AZD2171) (20, 30 or 45mg) When Co-Administered With Daily Oral Doses of AZD0530 (125mg or 175mg) in Patients With Advanced Solid Tumours', 'orgStudyIdInfo': {'id': 'D8480C00014'}, 'secondaryIdInfos': [{'id': 'EuDract #2006-003505-55'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'AZD2171 Monotherapy', 'interventionNames': ['Drug: AZD2171']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'AZD2171 + AZD0530', 'interventionNames': ['Drug: AZD2171', 'Drug: AZD0530']}], 'interventions': [{'name': 'AZD2171', 'type': 'DRUG', 'otherNames': ['cediranib', 'RECENTIN™'], 'description': 'oral tablet multiple ascending doses 20, 30 or 45 mg', 'armGroupLabels': ['1', '2']}, {'name': 'AZD0530', 'type': 'DRUG', 'description': 'oral tablet multiple ascending doses 125 mg or 175 mg', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Freiburg im Breisgau', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'city': 'Essen', 'state': 'Ruhr', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'city': 'Herne', 'state': 'Ruhr', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 51.5388, 'lon': 7.22572}}], 'overallOfficials': [{'name': 'Jane Roberston', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}, {'name': 'Tanja Trarbach, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitatsklinikum der GHS Essen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Jane Robertson, MSD', 'oldOrganization': 'AstraZeneca'}}}}