NCT00770185

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: NCIC Clinical Trials Group · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
DRUG	ridaforolimus	oral ridaforolimus 40 mg days 1-5 each week (once daily for 5 consecutive days every week; cycle arbitrarily defined as a 4 week period)
GENETIC	gene expression analysis
OTHER	immunohistochemistry staining method
OTHER	laboratory biomarker analysis

Timeline

• Start date: 2008-11-13
• Primary completion: 2012-03-19
• Completion: 2015-02-13
• First posted: 2008-10-09
• Last updated: 2023-08-04

Locations

11 sites across 1 country: Canada