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COMPLETEDPHASE1

A Study of XL765 (SAR245409) in Combination With Temozolomide With and Without Radiation in Adults With Malignant Gliomas

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

NCT00704080•Sanofi

View on ClinicalTrials.gov

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 dose. XL765 is a new chemical entity that inhibits the kinases PI3K and mTOR. In preclinical studies, inactivation of PI3K has been shown to inhibit growth and induce apoptosis (programmed cell death) in tumor cells, whereas inactivation of mTOR has been shown to inhibit the growth of tumor cells. Temozolomide (TMZ, Temodar®) is an orally administered alkylating agent with activity against malignant gliomas. It is approved by the Food and Drug Administration for the following indications: 1) treatment of newly diagnosed glioblastoma multiforme (GBM) patients when given concomitantly with radiotherapy and then as maintenance treatment; 2) refractory anaplastic astrocytoma (AA), ie, patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. Temozolomide is commonly used in the treatment of other anaplastic gliomas (AG) including oligodendroglial tumors and mixed gliomas.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (6)

Investigational Site Number

Birmingham, Alabama, United States

Investigational Site Number

Los Angeles, California, United States

Investigational Site Number

Boston, Massachusetts, United States

Investigational Site Number

New York, New York, United States

Investigational Site Number

Rochester, New York, United States

Investigational Site Number

Cleveland, Ohio, United States

Key Dates

Start Date

August 1, 2008

Primary Completion Date

February 1, 2012

Completion Date

February 1, 2013

Last Updated

April 10, 2013

Enrollment

ACTUAL participants

Conditions

Mixed GliomasMalignant GliomasGlioblastoma Multiforme

Interventions

XL765 (SAR245409)

DRUG

Temozolomide

DRUG

Targeted Pediatric High-Grade Glioma Therapy

NCT05839379

High Grade GliomaDiffuse Intrinsic Pontine Glioma+7 more

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RECRUITING

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

NCT00083512

Glioblastoma Multiforme

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 10, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of XL765 (SAR245409) in Combination With Temozolomide With and Without Radiation in Adults With Malignant Gliomas

Inclusion Criteria

Exclusion Criteria

Targeted Pediatric High-Grade Glioma Therapy

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