CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 61 enrolled
Drug / intervention
Sunitinibdrug
Likely dose
Sunitinib 50 mg orally daily for 4 weeks followed by 2 weeks off treatmentAI-extracted
Key inclusion· 4
  • ✓Histologically confirmed renal cell carcinoma with clear cell histology and metastases
  • ✓Measurable disease by imaging
  • ✓Radiographic disease progression during or within 3 months after bevacizumab-based treatment
  • ✓Prior radical or partial nephrectomy
Key exclusion· 4
  • ✕Prior anti-angiogenic therapy other than bevacizumab
  • ✕More than 2 prior systemic treatment regimens for RCC
  • ✕Known or prior history of brain metastases
  • ✕Serious acute or chronic illness or recent significant cardiac abnormality

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

Search/NCT00089648
NCT00089648Phase 2Completed
CompareCT.gov

A Phase 2 Study Of SU011248 In The Treatment Of Patients With Bevacizumab-Refractory Metastatic Renal Cell Carcinoma

Pfizer·interventional·Posted Aug 11, 2004·Updated Jan 12, 2010

In Brief

A Phase 2 clinical trial evaluating Sunitinib for Carcinoma, Renal Cell. Completed, enrolled 61 participants across 11 sites.

Detailed Summary

The purpose of this study is to test whether sunitinib (SU011248) has activity and is safe in patients with renal cell carcinoma (RCC) who have failed prior therapy with bevacizumab (Avastin) -based treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Renal Cell
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 11, 2004
Enrollment StartDec 1, 2004
Primary CompletionJan 1, 2007
Study CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 21.9 years ago

Interventions

Sunitinibdrug

50 mg orally daily for 4 weeks followed by 2 weeks off treatment for approximately 1 year or until disease progression/unacceptable toxicity; after completion of 1 year, pts with clinical benefit can continue the study treatment in a separate continuation protocol