A Phase 1 Safety Evaluation of Oral Enzastaurin in Combination With Bevacizumab in Patients With Advanced/Metastatic Cancer
OBJECTIVES:
- To determine the recommended phase II doses of enzastaurin hydrochloride and
bevacizumab that may be safely administered to patients with locally advanced or
metastatic malignancies.
- To characterize the toxicities of enzastaurin hydrochloride and bevacizumab in these
patients.
- To document the antitumor activity of enzastaurin hydrochloride and bevacizumab in
these patients.
- To evaluate the pharmacokinetics of enzastaurin hydrochloride and bevacizumab in these
patients.
- To assess GSK3β as a biomarker relevant to enzastaurin hydrochloride and its
correlation with clinical outcome in these patients.
OUTLINE: This is a dose-escalation study of enzastaurin hydrochloride and bevacizumab.
Patients receive oral enzastaurin hydrochloride once, twice, or three times daily on days
1-21 or days 1-28 and bevacizumab IV over 30-90 minutes on day 1 or days 1 and 15. Courses
repeat every 21 or 28 days in the absence of disease progression or unacceptable toxicity.
Blood samples are collected periodically during study for pharmacokinetic evaluation.
Samples are also analyzed for biomarker (GSK3β) by ELISA.
After completion of study treatment, patients are followed for 30 days.
National Cancer Institute (NCI) registered this trial with Eli Lilly as sponsor. NCI did
not update the record. In June 2012, NCI transferred the trial to Lilly's clinicaltrials.gov
account and Lilly updated the record with the trial status and trial completion dates. This
trial is not an applicable trial under Food and Drug Administration Amendments Act of 2007
(FDAAA).
Interventional
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Recommended phase II doses of enzastaurin hydrochloride and bevacizumab
Yes
Connie Collins, BSN
Sidney Kimmel Comprehensive Cancer Center
United States: Food and Drug Administration
11182
NCT00550927
November 2006
September 2012
Name | Location |
---|---|
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |