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

NCT ID: NCT03400306

Last Updated: 2021-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-15

Study Completion Date

2021-11-16

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer - Ovarian

Keywords

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Cancer - Ovarian cancer Bioavailability Pharmacokinetics Bioequivalence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1, Bioequivalence Sequence Group 1

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.

Group Type EXPERIMENTAL

Veliparib, capsule

Intervention Type DRUG

capsule; 50 mg or 100 mg

Veliparib, tablet

Intervention Type DRUG

tablet; 400 mg

Part 2, Extension

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

Group Type EXPERIMENTAL

Veliparib, capsule

Intervention Type DRUG

capsule; 50 mg or 100 mg

Carboplatin

Intervention Type DRUG

Intravenous

Paclitaxel

Intervention Type DRUG

Intravenous

Part 1, Bioequivalence Sequence Group 2

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.

Group Type EXPERIMENTAL

Veliparib, capsule

Intervention Type DRUG

capsule; 50 mg or 100 mg

Veliparib, tablet

Intervention Type DRUG

tablet; 400 mg

Interventions

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Veliparib, capsule

capsule; 50 mg or 100 mg

Intervention Type DRUG

Veliparib, tablet

tablet; 400 mg

Intervention Type DRUG

Carboplatin

Intravenous

Intervention Type DRUG

Paclitaxel

Intravenous

Intervention Type DRUG

Other Intervention Names

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ABT-888 ABT-888 Paraplatin Taxol

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Countries

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Denmark Netherlands United States

Other Identifiers

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2018-000313-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M15-536

Identifier Type: -

Identifier Source: org_study_id