To Determine the Food Effect and Bioavailability of Three Formulations of Veliparib in Subjects With Solid Tumors

November 17, 2017 updated by: AbbVie

A Phase 1, Single-Dose, Randomized, Group Sequential Cross-Over Study Evaluating the Bioavailability and Food Effect of Three Formulations of Veliparib on Pharmacokinetics in Subjects With Solid Tumors

Compare the bioavailability of three veliparib formulations in subjects with solid tumors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 1

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subjects with cytologically/histologically confirmed solid tumors that are either relapsed or refractory to standard therapy or there is no known effective therapy.
  2. In the opinion of the Investigator, life expectancy is 12 weeks or greater.
  3. Subjects with known brain metastases must have clinically controlled neurologic symptoms, defined as surgical excision and/or radiation therapy followed by 21 days of stable neurologic function and no evidence of central nervous system (CNS) disease progression as determined by computed tomography (CT) scan or magnetic resonance imaging (MRI) within 21 days prior to the first dose of study drug.
  4. Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2.
  5. Subject must have adequate bone marrow, renal and hepatic function per local laboratory reference range.

Exclusion Criteria:

  1. The subject is unable to swallow capsules or has nausea or vomiting.
  2. Female subject is pregnant or breast-feeding.
  3. Subject has a history of or an active medical condition(s) that affects absorption or motility (e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome).
  4. History of gastric surgery, vagotomy, bowel resection (except for left hemicolectomy) or any surgical procedure that might interfere with gastrointestinal motility, potentiometric hydrogen ion concentration (pH) or absorption.

  5. Subject exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to:

    • Known seizure disorder that is uncontrolled over the past month
    • Active uncontrolled infection
    • Unstable angina pectoris or cardiac arrhythmia
    • Psychiatric illness/social situation that would limit compliance with study requirements

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm A
Drug: veliparib
veliparib formulation A
Other Names:
  • ABT-888
Drug: veliparib
veliparib formulation B
Other Names:
  • ABT-888
Drug: veliparib
veliparib formulation C
Other Names:
  • ABT-888
  • velaparib
EXPERIMENTAL: Arm B
Drug: veliparib
veliparib formulation A
Other Names:
  • ABT-888
Drug: veliparib
veliparib formulation B
Other Names:
  • ABT-888
Drug: veliparib
veliparib formulation C
Other Names:
  • ABT-888
  • velaparib
EXPERIMENTAL: Arm C
Drug: veliparib
veliparib formulation A
Other Names:
  • ABT-888
Drug: veliparib
veliparib formulation B
Other Names:
  • ABT-888
Drug: veliparib
veliparib formulation C
Other Names:
  • ABT-888
  • velaparib
EXPERIMENTAL: Arm D
Drug: veliparib
veliparib formulation A
Other Names:
  • ABT-888
Drug: veliparib
veliparib formulation B
Other Names:
  • ABT-888
Drug: veliparib
veliparib formulation C
Other Names:
  • ABT-888
  • velaparib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the oral bioavailability of veliparib
Time Frame: Up to 4 weeks.
Assess the relative bioavailability of Formulation A, Formulation B and Formulation C with or without food measured using area under the plasma concentration-time curve (AUC), the maximum observed plasma concentration (Cmax), and time to Cmax (Tmax).
Up to 4 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the safety and tolerability of veliparib in patients with solid tumors
Time Frame: Up to 4 weeks
Safety and tolerability will be assessed through clinical laboratory tests, electrocardiograms (ECGs), vital signs, physical exams and adverse event assessments
Up to 4 weeks

Collaborators and Investigators

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

Sponsor

AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2010

Primary Completion (ACTUAL)

November 1, 2010

Study Completion (ACTUAL)

November 1, 2010

Study Registration Dates

First Submitted

July 19, 2010

First Submitted That Met QC Criteria

September 9, 2010

First Posted (ESTIMATE)

September 10, 2010

Study Record Updates

Last Update Posted (ACTUAL)

November 21, 2017

Last Update Submitted That Met QC Criteria

November 17, 2017

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M11-846

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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