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

Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01199224
• Other study ID #: M11-846
• Status: Completed
• Phase: Phase 1
• First received: July 19, 2010
• Last updated: November 17, 2017
• Start date: June 2010
• Est. completion date: November 2010

Study information

• Verified date: December 2010
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Solid Tumors

Intervention

Drug:
• veliparib
veliparib formulation A
• veliparib
veliparib formulation B
• veliparib
veliparib formulation C
• veliparib
veliparib formulation C

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To evaluate the safety and tolerability of veliparib in patients with solid tumors	Safety and tolerability will be assessed through clinical laboratory tests, electrocardiograms (ECGs), vital signs, physical exams and adverse event assessments	Up to 4 weeks