Status:
WITHDRAWN
A Study Evaluating the Bioavailability and Food Effect of Veliparib Tablets Followed by an Extension in Subjects With Ovarian Cancer
Lead Sponsor:
AbbVie
Conditions:
Cancer - Ovarian
Eligibility:
FEMALE
18-99 years
Phase:
PHASE1
Brief Summary
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 o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 16 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03400306
Start Date
November 15 2021
End Date
November 16 2021
Last Update
December 8 2021
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