drugset / Trial / NCT01517243

Phase II Study of Alternating Sunitinib and Temsirolimus

NCT01517243

Phase 2 Completed 37 enrolled Dartmouth-Hitchcock Medical Center
NaSingle-groupOpen-labelTreatment

Summary

In the past 5 years, treatment for metastatic Renal Cell Carcinoma (mRCC) has focused on agents directed at blocking tumor and vascular growth pathways. Sunitinib blocks the vascular endothelial growth factor receptor (VEGFr) and temsirolimus is an inhibitor of mammalian target of rapamycin (mTOR). Both sunitinib and temsirolimus are FDA approved agents for mRCC. When agents like these are given together, the toxicity increases but they can be given safely, at full doses, sequentially. We hypothesize that alternating these agents will double the progression free survival (PFS) of the agents when given sequentially.

Timeline

Start
2010-09-22
Primary completion
2018-08-20
Completion
2018-08-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Sunitinib Small molecule 50 mg Oral
Subject Temsirolimus Small molecule 25 mg Intravenous

Indications