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

AbbVie

Status and phase: Completed; Phase 1

Conditions: Solid Tumors

Treatments: Drug: veliparib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01199224

M11-846

Details and patient eligibility

About

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

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

27 participants in 4 patient groups

Arm A

Experimental group

Treatment:

Drug: veliparib

Drug: veliparib

Drug: veliparib

Drug: veliparib

Arm B

Experimental group

Treatment:

Drug: veliparib

Drug: veliparib

Drug: veliparib

Drug: veliparib

Arm C

Experimental group

Treatment:

Drug: veliparib

Drug: veliparib

Drug: veliparib

Drug: veliparib

Arm D

Experimental group

Treatment:

Drug: veliparib

Drug: veliparib

Drug: veliparib

Drug: veliparib