- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02483104
Veliparib in Combination With Carboplatin And Weekly Paclitaxel in Japanese Subjects With Ovarian Cancer
A Phase 1 Study of Veliparib in Combination With Carboplatin And Weekly Paclitaxel in Japanese Subjects With Ovarian Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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-
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Kurume-shi,Fukuoka, Japan
- Site Reference ID/Investigator# 128815
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Morioka-shi, Japan
- Site Reference ID/Investigator# 128997
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Nagaizumi-cho, Japan
- Site Reference ID/Investigator# 128058
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Histologically 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.
Participants must be newly diagnosed, chemotherapy-naïve, and entered between 1 and 12 weeks after initial cytoreductive surgery.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.
Adequate organ and marrow function.
Ability to swallow and retain oral medication, and no uncontrolled emesis.
Women 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.
Exclusion Criteria:
A 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).
Participants who received prior radiotherapy to any portion of the abdominal cavity or pelvis.
Participants who received prior chemotherapy for any abdominal or pelvic tumor.
Any investigational agents less than 4 weeks prior to study enrollment.
Any anti-cancer Chinese medicine/herbal remedies within 14 days prior to study enrollment.
Known 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.
Patients 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.
Prior therapy with a Poly-(ADP-ribose)-Polymerase (PARP) inhibitor.
Subject has a clinically significant uncontrolled condition(s), including but not limited to:
- Uncontrolled seizure disorder, or focal or generalized seizure within the last 12 months;
- Active infection that requires parenteral antibiotics;
- Known active hepatitis B or hepatitis C with abnormal liver function test or organ dysfunction;
- 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;
- Uncontrolled hypertension (sustained systolic blood pressure > 150 mmHg or diastolic pressure > 100 mmHg despite optimal medical management);
- Bowel obstruction or gastric outlet obstruction;
- Psychiatric illness/social situations that would limit compliance with study requirements;
- Any medical condition which in the opinion of the Investigator places the subject at an unacceptably high risk for toxicities.
Pregnant or lactating.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: veliparib (ABT-888)
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Veliparib will be given orally, twice daily on Days 1-21, every 21 days.
Other Names:
Carboplatin will be administered on Day 1 of each cycle, intravenously.
Other Names:
Paclitaxel will be administered on Days 1, 8, 15 of each cycle, intravenously.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with Dose-limiting toxicities
Time Frame: During the first cycle (21 days) of veliparib administration
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During the first cycle (21 days) of veliparib administration
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with adverse events
Time Frame: Approximately 5 months
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Collect all adverse events at each visit and assess according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03
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Approximately 5 months
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Preliminary tumor response
Time Frame: Participants will be evaluated for 5 months.
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According to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1
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Participants will be evaluated for 5 months.
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Maximum observed plasma concentration (Cmax) of Veliparib
Time Frame: For 24 hours following veliparib dosing.
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Maximum observed concentration, occurring at Tmax
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For 24 hours following veliparib dosing.
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The time to Cmax (peak time, Tmax) of Veliparib
Time Frame: For 24 hours following veliparib dosing.
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The time at which maximum plasma concentration (Cmax) is observed.
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For 24 hours following veliparib dosing.
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The area under the plasma concentration-time curve (AUC) of Veliparib
Time Frame: For 24 hours following veliparib dosing.
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For 24 hours following veliparib dosing.
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Hideyuki Hashiba, BS, AbbVie GK.
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Poly(ADP-ribose) Polymerase Inhibitors
- Carboplatin
- Paclitaxel
- Veliparib
Other Study ID Numbers
- M14-488
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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AbbVieCompleted
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-
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AbbVieWithdrawn
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AbbottCompletedSolid Tumor CancersUnited States