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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 NumberLos Angeles, California  90033
Investigational Site NumberBirmingham, Alabama  35205
Investigational Site NumberBoston, Massachusetts  02115
Investigational Site NumberNew York, New York  10021
Investigational Site NumberCleveland, Ohio  44195