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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01199224
Recruitment Status : Completed
First Posted : September 10, 2010
Last Update Posted : November 21, 2017
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: veliparib Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : June 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Arm Intervention/treatment
Experimental: Arm A Drug: veliparib
veliparib formulation A
Other Name: ABT-888
Experimental: Arm B Drug: veliparib
veliparib formulation B
Other Name: ABT-888
Experimental: Arm C Drug: veliparib
veliparib formulation C
Other Name: ABT-888
Experimental: Arm D Drug: veliparib
veliparib formulation C
Other Names:
  • ABT-888
  • velaparib

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01199224

Sponsors and Collaborators
Study Director: Bhardwaj Desai, MD Abbott

Publications of Results:
Responsible Party: AbbVie Identifier: NCT01199224     History of Changes
Other Study ID Numbers: M11-846
First Posted: September 10, 2010    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: December 2010

Keywords provided by AbbVie:
Solid Tumors

Additional relevant MeSH terms:
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents