A Study Evaluating the Bioavailability and Food Effect of Veliparib Tablets Followed by an Extension in Subjects With Ovarian Cancer
Phase 1
Withdrawn
- Conditions
- Cancer - Ovarian
- Interventions
- Registration Number
- NCT03400306
- Lead Sponsor
- AbbVie
- Brief Summary
This study will evaluate the bioavailability between the veliparib tablet formulation to the capsule formulation; and will assess the effect of food on veliparib bioavailability in participants with ovarian cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
- Diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
- Laboratory values meeting protocol-specified criteria, including hematologic, kidney and liver function.
- Life expectancy of 12 weeks or greater.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
- Able to swallow and retain oral medication.
- Discontinued anti-cancer therapy and biological agent for antineoplastic intent 21 days prior to the first dose of study drug, not have undergone major surgery 28 days prior to the first dose of study drug; and have recovered to Grade 0 - 2 for any clinical significant adverse event effect(s)/toxicity(s) from previous therapy.
- Non-childbearing potential.
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Exclusion Criteria
- History or active medical condition(s) affecting absorption or motility or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption.
- Evidence of refractory ascites.
- Has clinically relevant or significant electrocardiogram abnormalities.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Part 1, Bioequivalence Sequence Group 1 Veliparib, capsule Veliparib 400-mg doses administered orally on Day 1 of each 2-3 day period in Part 1 with the following sequence for the 3 dosing days: four 100 mg capsules under fasting conditions, followed by one 400-mg tablet under fasting conditions, then one 400 mg tablet under non-fasting conditions. Part 1, Bioequivalence Sequence Group 1 Veliparib, tablet Veliparib 400-mg doses administered orally on Day 1 of each 2-3 day period in Part 1 with the following sequence for the 3 dosing days: four 100 mg capsules under fasting conditions, followed by one 400-mg tablet under fasting conditions, then one 400 mg tablet under non-fasting conditions. Part 2, Extension Veliparib, capsule Veliparib as monotherapy or in combination with carboplatin and paclitaxel, per investigators' discretion. Part 2, Extension Carboplatin Veliparib as monotherapy or in combination with carboplatin and paclitaxel, per investigators' discretion. Part 2, Extension Paclitaxel Veliparib as monotherapy or in combination with carboplatin and paclitaxel, per investigators' discretion. Part 1, Bioequivalence Sequence Group 2 Veliparib, capsule Veliparib 400-mg doses administered orally on Day 1 of each 2-3 day period in Part 1 with the following sequence for the 3 dosing days: one 400-mg tablet under fasting conditions, followed by four 100 mg capsules under fasting conditions, then one 400 mg tablet under non-fasting conditions. Part 1, Bioequivalence Sequence Group 2 Veliparib, tablet Veliparib 400-mg doses administered orally on Day 1 of each 2-3 day period in Part 1 with the following sequence for the 3 dosing days: one 400-mg tablet under fasting conditions, followed by four 100 mg capsules under fasting conditions, then one 400 mg tablet under non-fasting conditions.
- Primary Outcome Measures
Name Time Method Terminal Phase Elimination Half-life (t1/2) Up to approximately 8 days after initial dose of study drug Terminal phase elimination half-life (t1/2)
Maximum observed plasma concentration (Cmax) Up to approximately 8 days after initial dose of study drug Maximum observed plasma concentration (Cmax)
Apparent Terminal Phase Elimination Rate Constant (β or Beta) Up to approximately 8 days after initial dose of study drug Apparent terminal phase elimination rate constant (β or Beta).
Time to Maximum Observed Plasma Concentration (Tmax) Up to approximately 8 days after initial dose of study drug Time to maximum observed plasma concentration (Tmax).
Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt) Up to approximately 8 days after initial dose of study drug Area under the plasma concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUCt).
AUC from time 0 to infinite time (AUC∞) Up to approximately 8 days after initial dose of study drug AUC from time 0 to infinite time (AUC∞)
- Secondary Outcome Measures
Name Time Method