CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 94 enrolled
Drug / intervention
Bevacizumab +2 moredrug
Likely dose
Bevacizumab 10 mg/kg IV infusion every 2 weeks, erlotinib 150 mg orally daily, imatinib 400-600 mg dailyAI-extracted
Key inclusion· 6
  • Metastatic or unresectable clear cell renal cell carcinoma confirmed by biopsy
  • Previous nephrectomy is required
  • Maximum of 1 previous systemic regimen for metastatic disease
  • Able to perform activities of daily living with minimal assistance
Key exclusion· 20
  • Age less than 18 years
  • Treatment with more than 1 previous systemic regimen
  • History of heart attack within 6 months
  • Clinically significant cardiovascular disease

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

Search/NCT00193258
NCT00193258Phase 2Completed

A Phase I/II Trial of Bevacizumab (Avastin), Erlotinib (Tarceva), and Imatinib (Gleevec) in the Treatment of Patients With Advanced Renal Cell Carcinoma

SCRI Development Innovations, LLC·interventional·Posted Sep 19, 2005·Updated Jan 31, 2013

In Brief

A Phase 2 clinical trial evaluating Bevacizumab, Erlotinib, and 1 other intervention for Clear Cell Renal Cell Carcinoma. Completed, enrolled 94 participants.

Detailed Summary

This phase I/II trial will evaluate the bevacizumab/erlotinib combination with the addition of imatinib (Gleevec). The combined inhibition greatly enhances the anti-tumor effects. Although the safety of the bevacizumab/erlotinib/imatinib combination has not yet been demonstrated, the mild to moderate side effects of all of these agents are not predicted to cause prohibitive toxicity. A brief phase I portion will be included in this trial, to optimize doses of the 3 agents prior to proceeding with the phase II trial.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 19, 2005
Enrollment StartJun 1, 2004
Primary CompletionJan 1, 2011
Study CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 20.8 years ago

Interventions

Bevacizumabdrug

10mg/kg IV infusion every 2 weeks

Erlotinibdrug

150 mg po daily

Imatinibdrug

400-600mg daily