Clinical trial · Interventional
A Study Evaluating the Bioavailability and Food Effect of Veliparib Tablets Followed by an Extension in Subjects With Ovarian Cancer
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
NCT03400306CI-TRIAL-00055422withdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Strategic considerations
Summary
Brief summary (as posted)
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.
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 |
|---|---|---|---|
| Cancer - Ovarian | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Veliparib, capsule | Drug | Veliparib | ALIAS |
| Veliparib, tablet | Drug | Veliparib | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Part 1, Bioequivalence Sequence Group 1
- description
- 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.
- interventionNames
- Drug: Veliparib, capsule
- Drug: Veliparib, tablet
- type
- EXPERIMENTAL
- label
- Part 2, Extension
- description
- Veliparib as monotherapy or in combination with carboplatin and paclitaxel, per investigators' discretion.
- interventionNames
- Drug: Veliparib, capsule
- Drug: Carboplatin
- Drug: Paclitaxel
- type
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.