Selumetinib With or Without Temsirolimus in Treating Patients With Metastatic, Recurrent, or Locally Advanced Soft Tissue Sarcoma That Cannot Be Removed By Surgery
NCT01206140 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70
Last updated 2015-10-05
Summary
This randomized phase II trial is studying how well giving selumetinib together with or without temsirolimus works in treating patients with metastatic, recurrent, or locally advanced soft tissue sarcoma that cannot be removed by surgery. Selumetinib and temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving selumetinib together with temsirolimus is more effective than giving selumetinib alone.
Conditions
- Recurrent Adult Soft Tissue Sarcoma
- Stage III Adult Soft Tissue Sarcoma
- Stage IV Adult Soft Tissue Sarcoma
Interventions
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
- DRUG
-
Selumetinib
Given PO
- DRUG
-
Temsirolimus
Given IV
Sponsors & Collaborators
-
National Comprehensive Cancer Network
collaborator NETWORK -
National Cancer Institute (NCI)
lead NIH
Principal Investigators
-
Warren Chow · City of Hope Comprehensive Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-10-31
- Primary Completion
- 2015-04-30
- Completion
- 2015-04-30
Countries
- United States
Study Locations
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