Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2026-02-25 @ 5:45 PM
Study NCT ID:
NCT02033551
Status:
COMPLETED
Last Update Posted:
2016-09-27
First Post:
2014-01-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Evaluating Veliparib as a Single Agent or in Combination With Chemotherapy in Subjects With Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue 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': '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': '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': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C521013', 'term': 'veliparib'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'C480833', 'term': 'IFL protocol'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-26', 'studyFirstSubmitDate': '2014-01-08', 'studyFirstSubmitQcDate': '2014-01-09', 'lastUpdatePostDateStruct': {'date': '2016-09-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of subjects with adverse events', 'timeFrame': 'Measured up to 30 days after the last dose of study drug.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Radiographic evaluation at Screening and every 6-9 weeks until the final visit, up to 18 months.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Every 3 months after the subject is registered off study up to 2 years post discontinuation or until date of death from any cause, whichever comes first.'}, {'measure': 'Time to Disease Progression (TTP)', 'timeFrame': 'Assessed at each visit up to 18 months after the last subject has enrolled in the study.'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Radiographic evaluation starting from the first day of study drug until documented progression or date of death, whichever comes first, until the subject is registered off study.'}, {'measure': 'Clinical Laboratory Tests', 'timeFrame': 'Up to 18 months.', 'description': 'Hematology, Chemistry, Urinalysis'}, {'measure': 'Electrocardiogram', 'timeFrame': 'Up to 18 months.'}, {'measure': 'Tumor Assessment', 'timeFrame': 'Up to 18 months.', 'description': 'A computerized tomography scan to document the size of the tumor.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Gastric Cancer', 'Lung Cancer', 'PARP Inhibitor', 'Ovarian Cancer', 'Solid Tumors', 'Breast Cancer', 'Colon Cancer'], 'conditions': ['Breast Cancer', 'Ovarian Cancer', 'Colon Cancer', 'Lung Cancer', 'Gastric Cancer', 'Solid Tumors']}, 'descriptionModule': {'briefSummary': 'This is an extension study to evaluate the safety of Veliparib monotherapy or in combination with Carboplatin plus Paclitaxel or modified Folinic Acid/Fluorouracil/Irinotecan (FOLFIRI) in subjects with solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have confirmed solid malignancy that is metastatic, and standard curative measures or other therapy that may provide clinical benefit do not exist or are no longer effective.\n* For Veliparib monotherapy (must have tumor with defects in DNA repair mechanisms (BRCA mutation or high grade ovarian cancer or solid tumors for combination therapy.\n* If the subject has known brain metastases must have clinically controlled neurologic symptoms, defined as surgical excision and/or radiation therapy followed by 21 days of stable neurologic function and no evidence of Central Nervous System (CNS) disease progression as determined by comparing a computed tomography (CT) scan or magnetic resonance imaging (MRI) scan performed during screening to a prior scan performed at least 4 weeks earlier and provided that the subject is asymptomatic, has no evidence of cavitation or hemorrhage, and does not require corticosteroids (must have discontinued steroids at least 3 months prior to study drug administration).\n* Subject must have adequate bone marrow, renal and hepatic function per local laboratory reference range.\n\nExclusion Criteria:\n\n* Subject has a clinically significant and uncontrolled major medical condition(s) including but not limited to:\n* Uncontrolled seizure disorder, including focal or generalized seizure within the last 12 months;\n* Uncontrolled nausea/vomiting/diarrhea;\n* Active uncontrolled infection;\n* Symptomatic congestive heart failure;\n* Unstable angina pectoris or cardiac arrhythmia;\n* Psychiatric illness/social situation that would limit compliance with study requirements;\n* Any medical condition, which in the opinion of the study investigator, places the subject at an unacceptably high risk for toxicities.\n* Subjects who have hypersensitivity to Carboplatin, Paclitaxel or Cremophor should be excluded from arm B.\n* Subject has received any of the following anti-cancer therapies 21 days prior to the first dose of study drug or a biologic agent for anti-neoplastic intent within 30 days prior to the first dose of study drug.\n* Subject who requires parenteral nutrition, tube feeding or has evidence of a partial bowel obstruction or perforation within 28 days prior to study drug.\n* The subject has had another active malignancy within the past 3 years except for any cancer in situ that the Principal Investigator considers to be cured.'}, 'identificationModule': {'nctId': 'NCT02033551', 'briefTitle': 'A Study Evaluating Veliparib as a Single Agent or in Combination With Chemotherapy in Subjects With Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'An Extension Study to Evaluate the Safety of Veliparib as Single Agent Therapy or in Combination With Chemotherapy in Subjects With Solid Tumors', 'orgStudyIdInfo': {'id': 'M14-144'}, 'secondaryIdInfos': [{'id': '2013-003137-16', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A - Veliparib Monotherapy', 'description': 'Subjects in this arm will be dosed with Veliparib continuous dosing.', 'interventionNames': ['Drug: Veliparib']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B - Veliparib in Combination with Carboplatin & Paclitaxel', 'description': 'Subjects enrolled will receive Veliparib in combination with Carboplatin and Paclitaxel and have an option to move to Veliparib monotherapy.', 'interventionNames': ['Drug: Veliparib', 'Drug: Carboplatin', 'Drug: Paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'Arm C Veliparib in Combination with Modified FOLFIRI', 'description': 'Subjects will be given Veliparib in combination with modified FOLFIRI. The subject will have the opportunity to receive Veliparib as monotherapy.', 'interventionNames': ['Drug: Veliparib', 'Drug: FOLFIRI']}], 'interventions': [{'name': 'Veliparib', 'type': 'DRUG', 'otherNames': ['ABT-888'], 'armGroupLabels': ['Arm A - Veliparib Monotherapy', 'Arm B - Veliparib in Combination with Carboplatin & Paclitaxel', 'Arm C Veliparib in Combination with Modified FOLFIRI']}, {'name': 'Carboplatin', 'type': 'DRUG', 'armGroupLabels': ['Arm B - Veliparib in Combination with Carboplatin & Paclitaxel']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'otherNames': ['Taxol'], 'armGroupLabels': ['Arm B - Veliparib in Combination with Carboplatin & Paclitaxel']}, {'name': 'FOLFIRI', 'type': 'DRUG', 'description': 'combination of Fluorouracil, leucovorin and irinotecan', 'armGroupLabels': ['Arm C Veliparib in Combination with Modified FOLFIRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 117416', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 117415', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '9713 GZ', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'Site Reference ID/Investigator# 117337', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': '6229 HX', 'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Site Reference ID/Investigator# 117338', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'zip': '28050', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Site Reference ID/Investigator# 117451', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Stacie Shepherd, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}