CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 37 enrolled
Drug / intervention
Sunitinib +1 moredrug
Likely dose
Sunitinib 50mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01517243
NCT01517243Phase 2Completed

Alternating Targeted Therapy in Patients With Metastatic Renal Cell Carcinoma: A Phase II Study of Alternating Sunitinib and Temsirolimus

Dartmouth-Hitchcock Medical Center·interventional·Posted Jan 25, 2012·Updated Sep 21, 2023

In Brief

A Phase 2 clinical trial evaluating Sunitinib and Temsirolimus for Metastatic Renal Cell Carcinoma. Completed, enrolled 37 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 25, 2012
Enrollment StartSep 22, 2010
Primary CompletionAug 20, 2018
TodayJul 2, 2026
Enrollment to primary: 7.9 yearsPosted 14.4 years ago

Interventions

Sunitinibdrug

Sunitinib 50mg by mouth daily for 4 weeks followed by a two week rest

Temsirolimusdrug

Temsirolimus 25mg IV weekly for 4 weeks followed by a two week rest