NCT01199224CompletedPhase 1
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
AbbVie0 sites27 target enrollmentStarted: June 2010Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 27
- Primary Endpoint
- Assess the oral bioavailability of veliparib
Study Overview
Brief Summary
Compare the bioavailability of three veliparib formulations in subjects with solid tumors.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
Arm A
Experimental
Intervention: veliparib (Drug)
Arm B
Experimental
Intervention: veliparib (Drug)
Arm C
Experimental
Intervention: veliparib (Drug)
Arm D
Experimental
Intervention: veliparib (Drug)
Outcomes
Primary Outcomes
Assess the oral bioavailability of veliparib
Time Frame: Up to 4 weeks.
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).
Secondary Outcomes
- To evaluate the safety and tolerability of veliparib in patients with solid tumors(Up to 4 weeks)
Investigators
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