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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT01199224
First received: July 19, 2010
Last updated: February 3, 2011
Last verified: December 2010
  Purpose

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


Condition Intervention Phase
Solid Tumors
Drug: veliparib
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Assess the oral bioavailability of veliparib [ Time Frame: Up to 4 weeks. ] [ Designated as safety issue: No ]
    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:
  • To evaluate the safety and tolerability of veliparib in patients with solid tumors [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: Yes ]
    Safety and tolerability will be assessed through clinical laboratory tests, electrocardiograms (ECGs), vital signs, physical exams and adverse event assessments


Enrollment: 27
Study Start Date: June 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A Drug: veliparib
veliparib formulation A
Other Names:
  • ABT-888
  • veliparib
Experimental: Arm B Drug: veliparib
veliparib formulation B
Other Names:
  • ABT-888
  • veliparib
Experimental: Arm C Drug: veliparib
veliparib formulation C
Other Names:
  • ABT-888
  • veliparib
Experimental: Arm D Drug: veliparib
veliparib formulation C
Other Names:
  • ABT-888
  • velaparib

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01199224

Locations
United States, California
Site Ref # / Investigator 42142
Encinitas, California, United States, 92024
Site Ref # / Investigator 41568
Santa Monica, California, United States, 90404
Sponsors and Collaborators
Abbott
Investigators
Study Director: Bhardwaj Desai, MD Abbott
  More Information

No publications provided

Responsible Party: Bhardwaj Desai, MD, Abbott
ClinicalTrials.gov Identifier: NCT01199224     History of Changes
Other Study ID Numbers: M11-846
Study First Received: July 19, 2010
Last Updated: February 3, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Solid Tumors
veliparib
refractory
relapsed

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on July 20, 2014