CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 106 enrolled
Drug / intervention
SU011248drug
Likely dose
50 mg orally daily for 4 weeks, followed by 2 weeks off-treatmentAI-extracted
Key inclusion· 3
  • ✓Cytokine-refractory metastatic renal cell carcinoma with clear cell component
  • ✓Radiographic evidence of disease progression during or within 9 months of completion of 1 cytokine therapy
  • ✓Prior nephrectomy
Key exclusion· 3
  • ✕Prior treatment with any systemic therapy other than 1 cytokine therapy
  • ✕History of or known brain metastases
  • ✕Uncontrolled hypertension or other significant cardiac events within the 12 months prior to study start

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

Search/NCT00077974
NCT00077974Phase 2Completed
CompareCT.gov

A Pivotal Study Of SU011248 In The Treatment Of Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma

Pfizer·interventional·Posted Feb 18, 2004·Updated Oct 13, 2010

In Brief

A Phase 2 clinical trial evaluating SU011248 for Carcinoma, Renal Cell. Completed, enrolled 106 participants across 15 sites.

Detailed Summary

To assess the safety and efficacy of SU011248 in patients with metastatic, refractory renal cell carcinoma

Study Details

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

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 18, 2004
Enrollment StartFeb 1, 2004
Primary CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 22.4 years ago

Interventions

SU011248drug

50-mg orally taken daily for 4 weeks and off treatment for 2 weeks until progression or unacceptable toxicity