Phase I Study of Enzastaurin and Temozolomide in Patients With Gliomas
Trial Snapshot
- Phase
- Phase 1
- Enrollment
- 28
- Locations
- 2
- Primary Endpoint
- Recommended phase II dose
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Recommended phase II dose
Dose-limiting toxicity
Secondary Outcomes
- Response rate
- Progression-free survival
- Overall survival
- Pharmacokinetics of enzastaurin hydrochloride alone and in combination with temozolomide