At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 25 enrolled
Drug / intervention
Erlotinib hydrochloride +1 moredrug
Likely dose
Erlotinib hydrochloride 150 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.
A Phase II Single Arm Clinical Trial to Evaluate the Efficacy and Safety of the Combination of Tarceva™ (Erlotinib Hydrochloride) and Rapamune™ (Sirolimus) in the Treatment of Metastatic Renal Cell Carcinoma.
In Brief
A Phase 2 clinical trial evaluating Erlotinib hydrochloride and Sirolimus for Renal Cell Carcinoma. Completed, enrolled 25 participants across 1 site.
Detailed Summary
The purpose of this study is to test the safety and efficacy of the combination of erlotinib hydrochloride (Tarceva™) and sirolimus (Rapamune™) in the treatment of patients with metastatic kidney cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Cell Carcinoma
CountriesUnited States
CollaboratorsGenentech, Inc.
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2006
First PostedJul 2006
Primary CompletionMar 2012
TodayJul 2026
First PostedJul 18, 2006
Enrollment StartJul 1, 2006
Primary CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 20.0 years ago
Interventions
Erlotinib hydrochloridedrug
Patients will receive single-agent Tarceva, 150 mg/day
Sirolimusdrug
Patients will receive a loading dose of 6 mg of Rapamune seven days after beginning treatment with Tarceva™ followed by a dose of 2mg/day.