Status:
COMPLETED
A Study of XL765 (SAR245409) in Combination With Temozolomide With and Without Radiation in Adults With Malignant Gliomas
Lead Sponsor:
Sanofi
Conditions:
Mixed Gliomas
Malignant Gliomas
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the safety and tolerability of XL765 in combination with Temozolomide in adults with anaplastic gliomas or glioblastoma on a stable Temozolomide maintenance d...
Eligibility Criteria
Inclusion
- Histologically confirmed intracranial Grade 3 or 4 anaplastic glioma or glioblastoma (astrocytic tumor, anaplastic oligodendroglioma, or oligoastrocytoma)
- Received prior standard radiation for a Grade 3 or 4 astrocytic tumor with a minimum cumulative dose of 40 Gy administered
- Completed at least one full cycle of temozolomide of 200 mg/m2/day administered on Days 1-5 of a 28-day cycle, without unacceptable toxicity or progression
- Karnofsky performance status of 60 or more
- Adequate organ and bone marrow function as defined by hematological and serum chemistry limits
- At least 18 years old.
- Both men and women must practice adequate contraception
- Informed consent
Exclusion
- Progressed while on temozolomide
- Evidence of acute intracranial or intratumoral hemorrhage \> Grade 1
- Restriction of some therapies/medications within specific timeframes prior to enrollment and during the study including cytotoxic chemotherapy other than temozolomide, biologic agents, nitrosoureas or mitomycin C, small-molecule kinase inhibitors, non-cytotoxic hormonal agents, prior therapy with a PI3K inhibitors, radiation therapy, enzyme-inducing anti-convulsants, valproic acid
- Not recovered from the toxic effects of prior therapy
- Pregnant or breast feeding
- History of diabetes mellitus
- Uncontrolled intercurrent illness
- Congestive heart failure, unstable angina, or a myocardial infarction within 3 months of entering the study.
- HIV positive
- Diagnosis of another malignancy may exclude subject from study
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00704080
Start Date
August 1 2008
End Date
February 1 2013
Last Update
April 10 2013
Active Locations (6)
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1
Investigational Site Number
Birmingham, Alabama, United States, 35205
2
Investigational Site Number
Los Angeles, California, United States, 90024
3
Investigational Site Number
Boston, Massachusetts, United States, 02115
4
Investigational Site Number
New York, New York, United States, 10021