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Spots Global Cancer Trial Database for Ridaforolimus in Treating Patients With Recurrent Metastatic and/or Locally Advanced Endometrial Cancer

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We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Ridaforolimus in Treating Patients With Recurrent Metastatic and/or Locally Advanced Endometrial Cancer

Official Title: A Phase II Study of Ridaforolimus in Patients With Metastatic And/Or Locally Advanced Recurrent Endometrial Cancer

Study ID: NCT00770185

Study Description

Brief Summary: RATIONALE: Ridaforolimus 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. PURPOSE: This phase II trial is studying the side effects of ridaforolimus and to see how well it works in treating patients with recurrent metastatic and/or locally advanced endometrial cancer.

Detailed Description: OBJECTIVES: * To assess the efficacy, in terms of objective response rate, of ridaforolimus, in patients with recurrent metastatic and/or locally advanced endometrial cancer. * To assess the adverse events, time to progression, and response duration of this drug in these patients. * To correlate objective tumor response with PTEN expression and other potential markers in primary tumor tissue from these patients. OUTLINE: This is a multicenter study. Patients receive oral ridaforolimus once daily on days 1-5 for 4 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Archived tumor tissue samples (paraffin block or unstained slides) are analyzed for PTEN gene expression and other mTOR pathway elements to explore possible markers of response or non-progression by immunohistochemistry. After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Tom Baker Cancer Centre, Calgary, Alberta, Canada

Cross Cancer Institute, Edmonton, Alberta, Canada

BCCA - Cancer Centre for the Southern Interior, Kelowna, British Columbia, Canada

BCCA - Fraser Valley Cancer Centre, Surrey, British Columbia, Canada

Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario, Canada

Cancer Centre of Southeastern Ontario at Kingston, Kingston, Ontario, Canada

London Regional Cancer Program, London, Ontario, Canada

Univ. Health Network-Princess Margaret Hospital, Toronto, Ontario, Canada

CHUM - Hopital Notre-Dame, Montreal, Quebec, Canada

McGill University - Dept. Oncology, Montreal, Quebec, Canada

Allan Blair Cancer Centre, Regina, Saskatchewan, Canada

Contact Details

Name: Amit M. Oza, MD

Affiliation: Princess Margaret Hospital, Canada

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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