Everolimus in Combination With Imatinib Mesylate in Treating Patients With Locally Advanced, Locally Recurrent, or Metastatic Soft Tissue Sarcoma
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|ClinicalTrials.gov Identifier: NCT01281865|
Recruitment Status : Completed
First Posted : January 24, 2011
Results First Posted : October 8, 2014
Last Update Posted : October 8, 2014
|Condition or disease||Intervention/treatment||Phase|
|Adult Synovial Sarcoma Recurrent Adult Soft Tissue Sarcoma Stage III Adult Soft Tissue Sarcoma Stage IV Adult Soft Tissue Sarcoma||Other: diagnostic laboratory biomarker analysis Drug: everolimus Drug: imatinib mesylate||Phase 1 Phase 2|
I. To determine the maximum-tolerated dose (MTD) of everolimus in combination with imatinib mesylate in patients with synovial sarcoma. (Phase I) II. To determine the overall response rate (RR = CR + PR). (Phase II)
I. To determine RR, progression-free survival (PFS), and overall survival (OS). (Phase I) II. To determine predictors of response. (Phase II) III. To obtain tissue biopsy and plasma samples for correlative studies pre- and post-treatment. (Phase II)
OUTLINE: This is a phase I, dose-escalation study of everolimus followed by a phase II study.
Patients receive everolimus orally (PO) once daily and imatinib mesylate PO once daily on days 1-28. Course repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood and tumor tissue sample collection at baseline and periodically during study for correlative biomarker and protein expression studies.
After completion of study therapy, patients are followed up for 30 days.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b/2 Study of Imatinib in Combination With Everolimus in Synovial Sarcoma|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2013|
U.S. FDA Resources
Experimental: Treatment (everolimus and imatinib mesylate)
Patients receive everolimus PO once daily and imatinib mesylate PO once daily on days 1-28. Course repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood and tumor tissue sample collection at baseline and periodically during study for correlative biomarker and protein expression studies.
Other: diagnostic laboratory biomarker analysis
Correlative studiesDrug: everolimus
Other Names:Drug: imatinib mesylate
- Response Rate (CR + PR) Assessed by RECIST 1.1 (Phase II) [ Time Frame: At 8 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01281865
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Mary Louise Keohan||Memorial Sloan Kettering Cancer Center|