Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-27 @ 11:47 PM
Study NCT ID:
NCT01661868
Status:
WITHDRAWN
Last Update Posted:
2012-08-21
First Post:
2011-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Olaparib for Patients With Recurrent BRCA Deficient Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D005185', 'term': 'Fallopian Tube Neoplasms'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C531550', 'term': 'olaparib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Drug not available.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-18', 'studyFirstSubmitDate': '2011-10-24', 'studyFirstSubmitQcDate': '2012-08-07', 'lastUpdatePostDateStruct': {'date': '2012-08-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response Rates', 'timeFrame': '1 year', 'description': 'To determine the RECIST 1.1. response rates of the oral PARP inhibitor olaparib based on prior exposure of a PARP inhibitor; patients who have received and subsequently have had disease progression with a prior PARP inhibitor versus no prior exposure to a PARP inhibitor in patients with germline BRCA mutations who have recurrent ovarian, fallopian tube or peritoneal cancer who have measurable cancer.'}], 'secondaryOutcomes': [{'measure': 'Toxicity', 'timeFrame': '1 year', 'description': 'Assess toxicity profile of olaparib according to the Common Terminology Criteria for Adverse Events (CTCAE, version 4)'}, {'measure': 'Progression free survival', 'timeFrame': '1 year', 'description': 'Assess progression free survival (PFS) and 6 month PFS rate'}, {'measure': 'Response Rate', 'timeFrame': '1 year', 'description': 'Assess CA125 response rate'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['BRCA1 mutation', 'BRCA2 mutation'], 'conditions': ['Ovarian Cancer', 'Peritoneal Cancer', 'Fallopian Tube Cancer']}, 'descriptionModule': {'briefSummary': 'This research study is a way of gaining new knowledge about a drug called olaparib in women who have either: 1)never received a PARP inhibitor before to treat ovarian cancer (group 1) or 2)participants who have received a PARP inhibitor before to treat ovarian cancer, with the exception of olaparib (group 2). PARP inhibitors are drugs tht prevent cancer cells from repairing their DNA. In this research study, we are looking to see how well the drug olaparib works in women who have never received a PARP inhibitor for recurrent ovarian cancer as well as those who have received a prior PARP inhibitor and whose cancer has re-grown after receiving that PARP inhibitor.', 'detailedDescription': 'Olaparib tablets will be taken twice daily, orally, in treatment cycles lasting 4 weeks.\n\nOn days 1, 8, 12 and 22 of the first 2 cycles and day 1 of all other cycles, subjects will have a physical exam, be asked questions about their general health, and specific questions about any problems they might be having and any medications they are taking.\n\nTumor will be assess by either CT or MRI scan every 2 cycles (every 2 months). Tumor biopsies will be optional in this study. Only participants that have received a PARP inhibitor in the past will be asked to have a biopsy of their tumor.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically confirmed ovarian, peritoneal or fallopian tube cancer that has recurred following a platinum-based regimen used at initial diagnosis\n* Measurable disease\n* Estimated life expectancy greater than 16 weeks\n* Normal organ and marrow function\n* Evidence of non-childbearing status for women of childbearing potential\n* Able to swallow oral medication\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Prior PARP inhibitor use for another cancer such as breast cancer\n* Receiving any other study agents or any other anti-cancer treatment\n* Known brain metastases\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to olaparib\n* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive hear failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements\n* History of a different malignancy unless disease-free for at least 5 years\n* Currently experiencing seizures or currently being treated with any anti-epileptic for seizures\n* Human immunodeficiency virus (HIV) positive on combination antiretroviral therapy\n* Presence of gastrointestinal disorders that, in the investigator's opinion, are likely to interfere with the absorption of olaparib, or with the patient's ability to take regular oral medication"}, 'identificationModule': {'nctId': 'NCT01661868', 'briefTitle': 'Olaparib for Patients With Recurrent BRCA Deficient Ovarian Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Dana-Farber Cancer Institute'}, 'officialTitle': 'Phase II Study of Single Agent Olaparib for Patients With Recurrent BRCA Deficient Ovarian Cancer With No Prior PARP Exposure or Prior PARP Inhibitor Exposure', 'orgStudyIdInfo': {'id': '11-170'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PARP Inhibitor Naive', 'description': 'Patients with no prior PARP inhibitor treatment', 'interventionNames': ['Drug: Olaparib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prior PARP Inhibitor', 'description': 'Patients previously treated with a PARP inhibitor other than olaparib', 'interventionNames': ['Drug: Olaparib']}], 'interventions': [{'name': 'Olaparib', 'type': 'DRUG', 'otherNames': ['AZD2281'], 'description': 'Tablet formulation will be used.', 'armGroupLabels': ['PARP Inhibitor Naive', 'Prior PARP Inhibitor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Ursula A Matulonis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dana-Farber Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ursula A. Matulonis, MD', 'investigatorAffiliation': 'Dana-Farber Cancer Institute'}}}}