A Study Evaluating the Bioavailability and Food Effect of Veliparib Tablets Followed by an Extension in Subjects With Ovarian Cancer

• Status: Not yet recruiting
• Trial end date: 2024-11-29
• Target enrollment: 0
• Participant gender: Female

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 ovarian cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Treatments: Carboplatin; Paclitaxel; Veliparib

Criteria

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.