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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumors

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assess the oral bioavailability of veliparib

Outcome Description:

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).

Outcome Time Frame:

Up to 4 weeks.

Safety Issue:

No

Principal Investigator

Bhardwaj Desai, MD

Investigator Role:

Study Director

Investigator Affiliation:

Abbott

Authority:

United States: Food and Drug Administration

Study ID:

M11-846

NCT ID:

NCT01199224

Start Date:

June 2010

Completion Date:

November 2010

Related Keywords:

  • Solid Tumors
  • Solid Tumors
  • veliparib
  • refractory
  • relapsed
  • Neoplasms

Name

Location

Site Ref # / Investigator 42142Encinitas, California  92024
Site Ref # / Investigator 41568Santa Monica, California  90404