Enzastaurin and Bevacizumab in Treating Patients With Locally Advanced or Metastatic Cancer

Phase 1

Completed

• Conditions: Unspecified Adult Solid Tumor, Protocol Specific

• Registration Number: NCT00550927
• Lead Sponsor: Eli Lilly and Company

Brief Summary

RATIONALE: Enzastaurin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Enzastaurin and bevacizumab may also stop the growth of cancer cells by blocking blood flow to the cancer. Giving enzastaurin together with bevacizumab may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of enzastaurin and bevacizumab in treating patients with locally advanced or metastatic cancer.

Detailed Description

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).

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2007-10-22
• Study First Submitted QC: 2007-10-25
• Study First Posted: 2007-10-30
• Primary Completion: 2010-03
• Status Verified: 2012-06
• Study Completion: 2012-09
• Last Update Submitted: 2013-05-14
• Last Update Posted: 2013-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to disease progression
Duration of stable disease
ECOG performance status over time
Pharmacokinetics
Biomarker (GSK3β) analysis
Recommended phase II doses of enzastaurin hydrochloride and bevacizumab
Safety
Overall response rate (complete and partial response)
Duration of response

Trial Locations

Locations (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States