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OpenTrials
Completed

NCT Number: NCT01199224

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects with cytologically/histologically confirmed solid tumors that are either relapsed or refractory to standard therapy or there is no known effective therapy.
  • In the opinion of the Investigator, life expectancy is 12 weeks or greater.
  • 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.
  • Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2.
  • Subject must have adequate bone marrow, renal and hepatic function per local laboratory reference range.

Exclusion criteria

  • The subject is unable to swallow capsules or has nausea or vomiting.
  • Female subject is pregnant or breast-feeding.
  • 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).
  • 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.
  • 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

Treatment and study plan

Veliparib

Drug

veliparib formulation A

Other names: ABT-888

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Sep 10, 2010
Registry last updated
Nov 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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