Status:
COMPLETED
To Determine the Food Effect and Bioavailability of Three Formulations of Veliparib in Subjects With Solid Tumors
Lead Sponsor:
AbbVie
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Compare the bioavailability of three veliparib formulations in subjects with solid tumors.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01199224
Start Date
June 1 2010
End Date
November 1 2010
Last Update
November 21 2017
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.