CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 69 enrolled
Drug / intervention
Pazopanib +3 moredrug
Likely dose
Pazopanib 800 mgfrom 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/NCT01392183
NCT01392183Phase 2Completed

A Randomized Phase 2 Trial of Pazopanib Versus Temsirolimus in Poor-Risk Clear-Cell Renal Cell Carcinoma

M.D. Anderson Cancer Center·interventional·Posted Jul 12, 2011·Updated Sep 20, 2021

In Brief

A Phase 2 clinical trial evaluating Pazopanib, Temsirolimus, and 2 other interventions for Kidney Cancer. Completed, enrolled 69 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to compare pazopanib to temsirolimus in the treatment of advanced clear-cell renal cell carcinoma. The safety of each drug will also be studied. Pazopanib is designed to block the growth of blood vessels that supply nutrients needed for tumor growth. This may prevent or slow the growth of cancer cells. Temsirolimus is designed to block the growth of cancer cells, which may cause cancer cells to die. This is an investigational study. Pazopanib and temsirolimus are both FDA approved and commercially available for the treatment of kidney cancer. It is investigational to compare the 2 drugs. Up to 90 patients will be enrolled in this study. All will be enrolled at MD Anderson.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Cancer
CountriesUnited States
CollaboratorsNovartis

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 12, 2011
Enrollment StartOct 24, 2012
Primary CompletionSep 8, 2019
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 15.0 years ago

Interventions

Pazopanibdrug

800 mg by mouth daily in 4 week study cycle.

Temsirolimusdrug

25 mg by vein infused over 30-60 minutes every week in 4 week study cycle.

Quality of Life Assessmentbehavioral

Completion of full assessment battery at baseline, prior to treatment then every 8 weeks at clinical evaluation.

Benadryldrug

25 to 50 mg by vein approximately 30 minutes before the start of each dose of temsirolimus.