Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-02-20 @ 10:45 PM
Study NCT ID:
NCT02483104
Status:
COMPLETED
Last Update Posted:
2017-11-20
First Post:
2015-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Veliparib in Combination With Carboplatin And Weekly Paclitaxel in Japanese Subjects With Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C521013', 'term': 'veliparib'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D017239', 'term': 'Paclitaxel'}], '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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-16', 'studyFirstSubmitDate': '2015-06-24', 'studyFirstSubmitQcDate': '2015-06-24', 'lastUpdatePostDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with Dose-limiting toxicities', 'timeFrame': 'During the first cycle (21 days) of veliparib administration'}], 'secondaryOutcomes': [{'measure': 'Number of participants with adverse events', 'timeFrame': 'Approximately 5 months', 'description': 'Collect all adverse events at each visit and assess according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03'}, {'measure': 'Preliminary tumor response', 'timeFrame': 'Participants will be evaluated for 5 months.', 'description': 'According to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1'}, {'measure': 'Maximum observed plasma concentration (Cmax) of Veliparib', 'timeFrame': 'For 24 hours following veliparib dosing.', 'description': 'Maximum observed concentration, occurring at Tmax'}, {'measure': 'The time to Cmax (peak time, Tmax) of Veliparib', 'timeFrame': 'For 24 hours following veliparib dosing.', 'description': 'The time at which maximum plasma concentration (Cmax) is observed.'}, {'measure': 'The area under the plasma concentration-time curve (AUC) of Veliparib', 'timeFrame': 'For 24 hours following veliparib dosing.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ABT-888', 'BRCA', 'Primary peritoneal cancer', 'carboplatin', 'Fallopian tube', 'Poly (ADP-ribose) polymerase (PARP)', 'paclitaxel', 'Ovarian cancer', 'veliparib'], 'conditions': ['Ovarian Cancer']}, 'referencesModule': {'references': [{'pmid': '28837250', 'type': 'RESULT', 'citation': 'Nishio S, Takekuma M, Takeuchi S, Kawano K, Tsuda N, Tasaki K, Takahashi N, Abe M, Tanaka A, Nagasawa T, Shoji T, Xiong H, Nuthalapati S, Leahy T, Hashiba H, Kiriyama T, Komarnitsky P, Hirashima Y, Ushijima K. Phase 1 study of veliparib with carboplatin and weekly paclitaxel in Japanese patients with newly diagnosed ovarian cancer. Cancer Sci. 2017 Nov;108(11):2213-2220. doi: 10.1111/cas.13381. Epub 2017 Sep 18.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase 1, open-label, multicenter, dose escalation study evaluating the tolerability, safety, pharmacokinetics and preliminary efficacy of veliparib in combination with carboplatin and weekly paclitaxel in Japanese subjects with ovarian cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHistologically or cytologically confirmed epithelial ovarian, fallopian tube or primary peritoneal carcinoma the International Federation of Gynecology and Obstetrics (FIGO) Stage IC - IV with either optimal (\\< 1 cm residual disease) or suboptimal residual disease.\n\nParticipants must be newly diagnosed, chemotherapy-naïve, and entered between 1 and 12 weeks after initial cytoreductive surgery.\n\nEastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.\n\nAdequate organ and marrow function.\n\nAbility to swallow and retain oral medication, and no uncontrolled emesis.\n\nWomen of childbearing potential (except vasectomized partner of female subjects) must agree to use adequate contraception prior to study entry, for the duration of study participation and up to 3 months following completion of therapy. Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to the study entry. Post menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.\n\nExclusion Criteria:\n\nA history of another invasive cancer within the past 3 years, except non-melanoma skin cancer or in situ malignancies that are considered cured by the investigator (e.g., cervical cancer in situ, in situ carcinoma of the bladder, or breast carcinoma in situ).\n\nParticipants who received prior radiotherapy to any portion of the abdominal cavity or pelvis.\n\nParticipants who received prior chemotherapy for any abdominal or pelvic tumor.\n\nAny investigational agents less than 4 weeks prior to study enrollment.\n\nAny anti-cancer Chinese medicine/herbal remedies within 14 days prior to study enrollment.\n\nKnown history of allergic reaction to Cremophor-paclitaxel, carboplatin, Azo Colourant Tartrazine (also known as FD\\&C Yellow 5 or E102), Azo Colourant Orange Yellow-S (also known as FD\\&C Yellow 6 or E110) or known contraindications to any study supplied drug.\n\nPatients with history or evidence upon physical examination of central nervous system disease, including primary brain tumor, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) within 6 months of the first date of treatment on this study.\n\nPrior therapy with a Poly-(ADP-ribose)-Polymerase (PARP) inhibitor.\n\nSubject has a clinically significant uncontrolled condition(s), including but not limited to:\n\n* Uncontrolled seizure disorder, or focal or generalized seizure within the last 12 months;\n* Active infection that requires parenteral antibiotics;\n* Known active hepatitis B or hepatitis C with abnormal liver function test or organ dysfunction;\n* Symptomatic congestive heart failure; unstable angina pectoris; serious ventricular cardiac arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation) or serious cardiac arrhythmia requiring medication (this does not include asymptomatic atrial fibrillation with controlled ventricular rate); or myocardial infarction within the last 6 months;\n* Uncontrolled hypertension (sustained systolic blood pressure \\> 150 mmHg or diastolic pressure \\> 100 mmHg despite optimal medical management);\n* Bowel obstruction or gastric outlet obstruction;\n* Psychiatric illness/social situations that would limit compliance with study requirements;\n* Any medical condition which in the opinion of the Investigator places the subject at an unacceptably high risk for toxicities.\n\nPregnant or lactating.'}, 'identificationModule': {'nctId': 'NCT02483104', 'briefTitle': 'Veliparib in Combination With Carboplatin And Weekly Paclitaxel in Japanese Subjects With Ovarian Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Phase 1 Study of Veliparib in Combination With Carboplatin And Weekly Paclitaxel in Japanese Subjects With Ovarian Cancer', 'orgStudyIdInfo': {'id': 'M14-488'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'veliparib (ABT-888)', 'interventionNames': ['Drug: veliparib', 'Drug: carboplatin', 'Drug: paclitaxel']}], 'interventions': [{'name': 'veliparib', 'type': 'DRUG', 'otherNames': ['ABT-888'], 'description': 'Veliparib will be given orally, twice daily on Days 1-21, every 21 days.', 'armGroupLabels': ['veliparib (ABT-888)']}, {'name': 'carboplatin', 'type': 'DRUG', 'otherNames': ['paraplatin'], 'description': 'Carboplatin will be administered on Day 1 of each cycle, intravenously.', 'armGroupLabels': ['veliparib (ABT-888)']}, {'name': 'paclitaxel', 'type': 'DRUG', 'otherNames': ['taxol'], 'description': 'Paclitaxel will be administered on Days 1, 8, 15 of each cycle, intravenously.', 'armGroupLabels': ['veliparib (ABT-888)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kurume-shi,Fukuoka', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 128815', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Morioka', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 128997', 'geoPoint': {'lat': 39.7, 'lon': 141.15}}, {'city': 'Nagaizumi-cho', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 128058'}], 'overallOfficials': [{'name': 'Hideyuki Hashiba, BS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}