Clinical trial · Interventional
To Determine the Food Effect and Bioavailability of Three Formulations of Veliparib in Subjects With Solid Tumors
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
NCT01199224CI-TRIAL-00030470completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Compare the bioavailability of three veliparib formulations in subjects with solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| veliparib | Drug | Veliparib | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Arm A
- interventionNames
- Drug: veliparib
- type
- EXPERIMENTAL
- label
- Arm B
- interventionNames
- Drug: veliparib
- type
- EXPERIMENTAL
- label
- Arm C
- interventionNames
- Drug: veliparib
- type
- EXPERIMENTAL
- label
- Arm D
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subjects with cytologically/histologically confirmed solid tumors that are either relapsed or refractory to standard therapy or there is no known effective therapy. 2. In the opinion of the Investigator, life expectancy is 12 weeks or greater. 3. 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. 4. Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2. 5. Subject must have adequate bone marrow, renal and hepatic function per local laboratory reference range. Exclusion Criteria: 1. The subject is unable to swallow capsules or has nausea or vomiting. 2. Female subject is pregnant or breast-feeding. 3. 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). 4. 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. 5. 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
References
Publications (1)
- RESULTMostafa NM, Chiu YL, Rosen LS, Bessudo A, Kovacs X, Giranda VL. A phase 1 study to evaluate effect of food on veliparib pharmacokinetics and relative bioavailability in subjects with solid tumors. Cancer Chemother Pharmacol. 2014 Sep;74(3):583-91. doi: 10.1007/s00280-014-2529-2. Epub 2014 Jul 23. PMID 25053388