Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-26 @ 11:58 PM
Study NCT ID:
NCT01033292
Status:
COMPLETED
Last Update Posted:
2016-03-17
First Post:
2009-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Single-Arm Study Evaluating Carboplatin/Gemcitabine in Combination With BSI-201 in Patients With Platinum-Resistant Recurrent Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C090712', 'term': 'iniparib'}, {'id': 'D000067856', 'term': 'Poly(ADP-ribose) Polymerase Inhibitors'}], 'ancestors': [{'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000970', 'term': 'Antineoplastic Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'nctId': 'NCT01130259', 'statusForNctId': 'NO_LONGER_AVAILABLE', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2016-02', 'dispFirstSubmitDate': '2016-02-17', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-17', 'studyFirstSubmitDate': '2009-12-14', 'dispFirstSubmitQcDate': '2016-02-17', 'studyFirstSubmitQcDate': '2009-12-15', 'dispFirstPostDateStruct': {'date': '2016-03-17', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-03-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the objective response rate (ORR) of gemcitabine/carboplatin in combination with BSI-201', 'timeFrame': 'Until progressive disease or death'}], 'secondaryOutcomes': [{'measure': 'To determine the nature and degree of toxicity of gemcitabine/carboplatin in combination with BSI-201', 'timeFrame': '30 days after last BSI-201 exposure'}, {'measure': 'To evaluate progression-free survival (PFS) of gemcitabine/carboplatin in combination with BSI-201', 'timeFrame': 'until progressive disease or death'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ovarian', 'cancer', 'sensitive', 'PARP', 'recurrent', 'platinum-resistant recurrent ovarian cancer'], 'conditions': ['Ovarian Cancer']}, 'referencesModule': {'references': [{'pmid': '36718018', 'type': 'DERIVED', 'citation': 'Penson RT, Ambrosio AJ, Whalen CA, Krasner CN, Konstantinopoulos PA, Bradley C, Matulonis UA, Birrer MJ. Phase II Trials of Iniparib (BSI-201) in Combination with Gemcitabine and Carboplatin in Patients with Recurrent Ovarian Cancer. Oncologist. 2023 Mar 17;28(3):252-257. doi: 10.1093/oncolo/oyac275.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of BSI-201 on the objective response rate in platinum-resistant recurrent ovarian cancer patients receiving gemcitabine and carboplatin.\n\nBased on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years of age\n* Histological diagnosis of epithelial ovarian carcinoma, fallopian tube cancer, or primary peritoneal carcinoma\n* Completion of only one previous course of chemotherapy which contained a platinum therapy, with resistance to that regimen. "Platinum-resistance" is defined by a relapse within 2 to 6 months after termination of platinum-based chemotherapy\n* Measurable disease, defined by at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded), and is ≥ 20 mm when measured by conventional techniques (palpation, plain x-ray, computed tomography \\[CT\\], or magnetic resonance imaging \\[MRI\\]) or ≥ 10 mm when measured by spiral CT\n* Adequate organ function defined as: absolute neutrophil count (ANC) ≥ 1,500/mm3, platelets ≥ 100,000/mm3, creatinine clearance \\> 50mL/min, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\< 2.5 x upper limit of normal (ULN; or \\< 5 x ULN in case of liver metastases); total bilirubin \\< 1.5 mg/dL\n* For women of child bearing potential, documented negative pregnancy test within two weeks of study entry and agreement to acceptable birth control during the duration of the study therapy\n* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2\n* Signed, institutional review board (IRB) approved written informed consent\n\nExclusion Criteria:\n\n* Concurrent invasive malignancy, not including:\n\n 1. Non-melanomatous skin cancer\n 2. In situ malignancies\n 3. Concurrent superficial endometrial carcinoma, if their endometrial carcinoma is superficial or invades less than 50% the thickness of the myometrium)\n 4. Low risk breast cancer (localized, non-inflammatory) treated with curative intent\n* Lesions identifiable only by positron emission tomography (PET)\n* Prior treatment with poly (ADP-ribose) polymerase (PARP) inhibitors, including BSI-201\n* Major medical conditions that might affect study participation (i.e., uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled infection)\n* Other significant co-morbid condition which the investigator feels might compromise effective and safe participation in the study, including a history of congestive cardiac failure or an electrocardiogram (ECG) suggesting significant conduction defect or myocardial ischemia\n* Enrollment in another investigational device or drug study, or current treatment with other investigational agents\n* Concurrent radiation therapy to treat primary disease throughout the course of the study\n* Inability to comply with the requirements of the study\n* Pregnancy or lactation\n* Leptomeningeal disease or brain metastases requiring steroids or other therapeutic intervention'}, 'identificationModule': {'nctId': 'NCT01033292', 'briefTitle': 'A Single-Arm Study Evaluating Carboplatin/Gemcitabine in Combination With BSI-201 in Patients With Platinum-Resistant Recurrent Ovarian Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Phase 2, Multi-Center, Single-Arm Study Evaluating Carboplatin/Gemcitabine in Combination With BSI-201 in Patients With Platinum-Resistant Recurrent Ovarian Cancer', 'orgStudyIdInfo': {'id': 'TCD11504'}, 'secondaryIdInfos': [{'id': '20090208', 'type': 'OTHER', 'domain': 'BiPar'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BSI-201', 'description': 'BSI-201 in combination with gemcitabine and carboplatin.', 'interventionNames': ['Drug: BSI-201']}], 'interventions': [{'name': 'BSI-201', 'type': 'DRUG', 'otherNames': ['PARP inhibitor'], 'description': 'IV infusion, 5.6 mg/kg', 'armGroupLabels': ['BSI-201']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts Ceneral Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}