A Study Evaluating the Bioavailability and Food Effect of Veliparib Tablets Followed by an Extension in Subjects With Ovarian Cancer

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1, Single-Dose, Open-Label, Randomized Cross-Over Study Evaluating the Bioavailability and Food Effect of Veliparib Tablets Followed by an Extension in Subjects With Ovarian Cancer

Conditions
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Cancer - Ovarian

Intervention / Treatment
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* Drug: Veliparib, capsule
* Drug: Veliparib, tablet
* Drug: Carboplatin
* Drug: Paclitaxel


Participation Criteria
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Eligibility Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1, Bioequivalence Sequence Group 1<br>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. | Drug: Veliparib, capsule<br>* capsule; 50 mg or 100 mg<br>* Other names: ABT-888;Drug: Veliparib, tablet<br>* tablet; 400 mg<br>* Other names: ABT-888;|
| Experimental: Part 2, Extension<br>Veliparib as monotherapy or in combination with carboplatin and paclitaxel, per investigators' discretion. | Drug: Veliparib, capsule<br>* capsule; 50 mg or 100 mg<br>* Other names: ABT-888;Drug: Carboplatin<br>* Intravenous<br>* Other names: Paraplatin;Drug: Paclitaxel<br>* Intravenous<br>* Other names: Taxol;|
| Experimental: Part 1, Bioequivalence Sequence Group 2<br>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. | Drug: Veliparib, capsule<br>* capsule; 50 mg or 100 mg<br>* Other names: ABT-888;Drug: Veliparib, tablet<br>* tablet; 400 mg<br>* Other names: ABT-888;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) | Maximum observed plasma concentration (Cmax) | Up to approximately 8 days after initial dose of study drug | 
| Time to Maximum Observed Plasma Concentration (Tmax) | Time to maximum observed plasma concentration (Tmax). | Up to approximately 8 days after initial dose of study drug | 
| Apparent Terminal Phase Elimination Rate Constant (β or Beta) | Apparent terminal phase elimination rate constant (β or Beta). | Up to approximately 8 days after initial dose of study drug | 
| Terminal Phase Elimination Half-life (t1/2) | Terminal phase elimination half-life (t1/2) | 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) | 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 | 
| AUC from time 0 to infinite time (AUC∞) | AUC from time 0 to infinite time (AUC∞) | Up to approximately 8 days after initial dose of study drug | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer - Ovarian cancer, Bioavailability, Pharmacokinetics, Bioequivalence