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

NCT01199224 | Completed Phase 1

• 1 other identifier: M11-846
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Solid Tumors

Keywords

Solid Tumors; veliparib; refractory; relapsed

Outcome Measures

Primary Outcomes (1)

• Assess the oral bioavailability of veliparib

  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).

  Up to 4 weeks.

Secondary Outcomes (1)

• To evaluate the safety and tolerability of veliparib in patients with solid tumors

  Up to 4 weeks

Study Arms (4)

Arm A

EXPERIMENTAL

Drug: veliparib

Arm B

EXPERIMENTAL

Drug: veliparib

Arm C

EXPERIMENTAL

Drug: veliparib

Arm D

EXPERIMENTAL

Drug: veliparib

Interventions

veliparib DRUG

veliparib formulation A

Also known as: ABT-888

Arm A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

Related Publications (1)

• Mostafa NM, Chiu YL, Rosen LS, Bessudo A, Kovacs X, Giranda VL. A phase 1 study to evaluate effect of food on veliparib pharmacokinetics and relative bioavailability in subjects with solid tumors. Cancer Chemother Pharmacol. 2014 Sep;74(3):583-91. doi: 10.1007/s00280-014-2529-2. Epub 2014 Jul 23.

  PMID: 25053388 RESULT

MeSH Terms

Conditions

Recurrence

Interventions

veliparib

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bhardwaj Desai, MD

  Abbott

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2010
• First Posted: September 10, 2010
• Study Start: June 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: November 21, 2017

Record last verified: 2010-12