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A Phase 1 Dose-Escalation Study of XL765 (SAR245409) in Combination With Temozolomide With and Without Radiation in Subjects With Malignant Gliomas

Phase 1
18 Years
Not Enrolling
Mixed Gliomas, Malignant Gliomas, Glioblastoma Multiforme

Thank you

Trial Information

A Phase 1 Dose-Escalation Study of XL765 (SAR245409) in Combination With Temozolomide With and Without Radiation in Subjects With Malignant Gliomas

Inclusion Criteria:

- 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 Criteria:

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety, tolerability, and maximum tolerated dose of XL765 administered in combination with temozolomide in subjects with anaplastic gliomas or glioblastoma currently stable on a maintenance temozolomide dose

Outcome Time Frame:

Assessed at each visit/periodic visits

Safety Issue:


Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

August 2008

Completion Date:

February 2013

Related Keywords:

  • Mixed Gliomas
  • Malignant Gliomas
  • Glioblastoma Multiforme
  • GBM
  • Anaplastic glioma
  • Glioblastoma
  • Glioma



Investigational Site Number Los Angeles, California  90033
Investigational Site Number Birmingham, Alabama  35205
Investigational Site Number Boston, Massachusetts  02115
Investigational Site Number New York, New York  10021
Investigational Site Number Cleveland, Ohio  44195