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

December 6, 2021 updated by: AbbVie

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Veliparib, capsule
capsule; 50 mg or 100 mg
Other Names:
  • ABT-888
Drug: Veliparib, tablet
tablet; 400 mg
Other Names:
  • ABT-888
Experimental: Part 2, Extension
Veliparib as monotherapy or in combination with carboplatin and paclitaxel, per investigators' discretion.
Drug: Veliparib, capsule
capsule; 50 mg or 100 mg
Other Names:
  • ABT-888
Drug: Carboplatin
Intravenous
Other Names:
  • Paraplatin
Drug: Paclitaxel
Intravenous
Other Names:
  • Taxol
Experimental: 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.
Drug: Veliparib, capsule
capsule; 50 mg or 100 mg
Other Names:
  • ABT-888
Drug: Veliparib, tablet
tablet; 400 mg
Other Names:
  • ABT-888

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum observed plasma concentration (Cmax)
Time Frame: Up to approximately 8 days after initial dose of study drug
Maximum observed plasma concentration (Cmax)
Up to approximately 8 days after initial dose of study drug
Time to Maximum Observed Plasma Concentration (Tmax)
Time Frame: Up to approximately 8 days after initial dose of study drug
Time to maximum observed plasma concentration (Tmax).
Up to approximately 8 days after initial dose of study drug
Apparent Terminal Phase Elimination Rate Constant (β or Beta)
Time Frame: Up to approximately 8 days after initial dose of study drug
Apparent terminal phase elimination rate constant (β or Beta).
Up to approximately 8 days after initial dose of study drug
Terminal Phase Elimination Half-life (t1/2)
Time Frame: Up to approximately 8 days after initial dose of study drug
Terminal phase elimination half-life (t1/2)
Up to approximately 8 days after initial dose of study drug
Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)
Time Frame: Up to approximately 8 days after initial dose of study drug
Area under the plasma concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUCt).
Up to approximately 8 days after initial dose of study drug
AUC from time 0 to infinite time (AUC∞)
Time Frame: Up to approximately 8 days after initial dose of study drug
AUC from time 0 to infinite time (AUC∞)
Up to approximately 8 days after initial dose of study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 15, 2021

Primary Completion (Actual)

November 16, 2021

Study Completion (Actual)

November 16, 2021

Study Registration Dates

First Submitted

January 12, 2018

First Submitted That Met QC Criteria

January 12, 2018

First Posted (Actual)

January 17, 2018

Study Record Updates

Last Update Posted (Actual)

December 8, 2021

Last Update Submitted That Met QC Criteria

December 6, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M15-536
  • 2018-000313-20 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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