Enzastaurin and Temozolomide in Treating Patients With Primary Gliomas

Phase 1

• Conditions: Brain and Central Nervous System Tumors

• Registration Number: NCT00516607
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary

RATIONALE: Enzastaurin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving enzastaurin together with temozolomide may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of enzastaurin when given together with temozolomide in treating patients with primary gliomas.

Detailed Description

OBJECTIVES:

* To assess if full doses of enzastaurin hydrochloride and temozolomide can be used in combination for the treatment of patients with primary gliomas.

* To determine the recommended phase II dose.

OUTLINE: This is a multicenter study.

Patients receive oral enzastaurin hydrochloride once or twice daily on days 1-28\* and oral temozolomide once daily on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

NOTE: \*During the first course only, patients also receive enzastaurin hydrochloride on day -1.

Patients undergo blood sample collection on day 22 of course 1 and on day 5 of course 2 for pharmacokinetic studies of enzastaurin hydrochloride.

After completion of study treatment, patients are followed within 30 days and then every 3 months thereafter.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-08-14
• Study First Submitted QC: 2007-08-14
• Study First Posted: 2007-08-15
• Primary Completion: 2008-11
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-09
• Last Update Posted: 2015-02-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recommended phase II dose
Dose-limiting toxicity

Secondary Outcome Measures

Name	Time	Method
Response rate
Overall survival
Progression-free survival
Pharmacokinetics of enzastaurin hydrochloride alone and in combination with temozolomide

Trial Locations

Locations (1)

Beatson West of Scotland Cancer Centre; 🇬🇧 Glasgow, Scotland, United Kingdom