To Determine the Food Effect and Bioavailability of Three Formulations of Veliparib in Subjects With Solid Tumors

Study Overview
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Brief Summary
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Compare the bioavailability of three veliparib formulations in subjects with solid tumors.

Official Title
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A Phase 1, Single-Dose, Randomized, Group Sequential Cross-Over Study Evaluating the Bioavailability and Food Effect of Three Formulations of Veliparib on Pharmacokinetics in Subjects With Solid Tumors

Conditions
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Solid Tumors

Intervention / Treatment
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* Drug: veliparib
* Drug: veliparib
* Drug: veliparib
* Drug: veliparib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with cytologically/histologically confirmed solid tumors that are either relapsed or refractory to standard therapy or there is no known effective therapy. In the opinion of the Investigator, life expectancy is 12 weeks or greater. Subjects with known brain metastases must have clinically controlled neurologic symptoms, defined as surgical excision and/or radiation therapy followed by 21 days of stable neurologic function and no evidence of central nervous system (CNS) disease progression as determined by computed tomography (CT) scan or magnetic resonance imaging (MRI) within 21 days prior to the first dose of study drug. Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2. Subject must have adequate bone marrow, renal and hepatic function per local laboratory reference range. Exclusion Criteria: The subject is unable to swallow capsules or has nausea or vomiting. Female subject is pregnant or breast-feeding. Subject has a history of or an active medical condition(s) that affects absorption or motility (e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome). History of gastric surgery, vagotomy, bowel resection (except for left hemicolectomy) or any surgical procedure that might interfere with gastrointestinal motility, potentiometric hydrogen ion concentration (pH) or absorption. Subject exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to: Known seizure disorder that is uncontrolled over the past month Active uncontrolled infection Unstable angina pectoris or cardiac arrhythmia Psychiatric illness/social situation that would limit compliance with study requirements

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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: Arm A<br> | Drug: veliparib<br>* veliparib formulation A<br>* Other names: ABT-888;|
| Experimental: Arm B<br> | Drug: veliparib<br>* veliparib formulation B<br>* Other names: ABT-888;|
| Experimental: Arm C<br> | Drug: veliparib<br>* veliparib formulation C<br>* Other names: ABT-888;|
| Experimental: Arm D<br> | Drug: veliparib<br>* veliparib formulation C<br>* Other names: velaparib;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the oral bioavailability of veliparib | Assess the relative bioavailability of Formulation A, Formulation B and Formulation C with or without food measured using area under the plasma concentration-time curve (AUC), the maximum observed plasma concentration (Cmax), and time to Cmax (Tmax). | Up to 4 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of veliparib in patients with solid tumors | Safety and tolerability will be assessed through clinical laboratory tests, electrocardiograms (ECGs), vital signs, physical exams and adverse event assessments | Up to 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Solid Tumors, veliparib, refractory, relapsed