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

AbbVie

Status and phase: Withdrawn; Phase 1

Conditions: Cancer - Ovarian

Treatments: Drug: Veliparib, capsule; Drug: Paclitaxel; Drug: Carboplatin; Drug: Veliparib, tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT03400306

2018-000313-20 (EudraCT Number)

M15-536

Details and patient eligibility

About

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.

Sex: Female

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Part 1, Bioequivalence Sequence Group 1

Experimental group

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.

Treatment:

Drug: Veliparib, tablet

Drug: Veliparib, capsule

Part 2, Extension

Experimental group

Description:

Veliparib as monotherapy or in combination with carboplatin and paclitaxel, per investigators' discretion.

Treatment:

Drug: Carboplatin

Drug: Paclitaxel

Drug: Veliparib, capsule

Part 1, Bioequivalence Sequence Group 2

Experimental group

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: one 400-mg tablet under fasting conditions, followed by four 100 mg capsules under fasting conditions, then one 400 mg tablet under non-fasting conditions.

Treatment:

Drug: Veliparib, tablet

Drug: Veliparib, capsule