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

NCT ID: NCT01199224

Last Updated: 2017-11-21

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2010-11-30

Brief Summary

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

Detailed Description

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Conditions

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Solid Tumors

Keywords

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Solid Tumors veliparib refractory relapsed

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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Arm A

Group Type EXPERIMENTAL

veliparib

Intervention Type DRUG

veliparib formulation A

Arm B

Group Type EXPERIMENTAL

veliparib

Intervention Type DRUG

veliparib formulation B

Arm C

Group Type EXPERIMENTAL

veliparib

Intervention Type DRUG

veliparib formulation C

Arm D

Group Type EXPERIMENTAL

veliparib

Intervention Type DRUG

veliparib formulation C

Interventions

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veliparib

veliparib formulation A

Intervention Type DRUG

veliparib

veliparib formulation B

Intervention Type DRUG

veliparib

veliparib formulation C

Intervention Type DRUG

veliparib

veliparib formulation C

Intervention Type DRUG

Other Intervention Names

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ABT-888 ABT-888 ABT-888 ABT-888 velaparib

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

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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Bhardwaj Desai, MD

Role: STUDY_DIRECTOR

Abbott

Countries

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United States

References

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Mostafa NM, Chiu YL, Rosen LS, Bessudo A, Kovacs X, Giranda VL. A phase 1 study to evaluate effect of food on veliparib pharmacokinetics and relative bioavailability in subjects with solid tumors. Cancer Chemother Pharmacol. 2014 Sep;74(3):583-91. doi: 10.1007/s00280-014-2529-2. Epub 2014 Jul 23.

Reference Type RESULT
PMID: 25053388 (View on PubMed)

Other Identifiers

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M11-846

Identifier Type: -

Identifier Source: org_study_id