CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 107 enrolled
Drug / intervention
SU011248 (sunitinib)drug
Likely dose
Sunitinib (SU011248) 37.5 mg orally once daily, continuousAI-extracted
Key inclusion· 5
  • ✓Histologically confirmed metastatic renal cell carcinoma
  • ✓Measurable disease by RECIST criteria
  • ✓Failure of exactly 1 prior cytokine-based therapy for metastatic disease (IFN-α must be ≥4 weeks duration)
  • ✓ECOG performance status 0 or 1
Key exclusion· 10
  • ✕Prior systemic therapy other than 1 cytokine-based regimen
  • ✕Prior treatment on a sunitinib (SU011248) clinical trial
  • ✕Chemotherapy, radiation, or major surgery within 4 weeks of study start
  • ✕Second malignancy diagnosis within 3 years (except basal cell, squamous cell skin cancer, or adequately treated in situ carcinoma with 12-month disease-free period)

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

Search/NCT00137423
NCT00137423Phase 2Completed
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A Phase 2 Efficacy And Safety Study Of SU011248 Administered In A Continuous Daily Regimen In Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma

Pfizer·interventional·Posted Aug 29, 2005·Updated Sep 30, 2009

In Brief

A Phase 2 clinical trial evaluating SU011248 (sunitinib) for Carcinoma, Renal Cell Metastasis. Completed, enrolled 107 participants across 10 sites in 7 countries.

Detailed Summary

To evaluate the anti-tumor activity of SU011248 (sunitinib) in cytokine-refractory metastatic renal cell carcinoma (RCC) when administered in a continuous treatment regimen

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Renal Cell Metastasis
CountriesFrance, Germany, Greece, Netherlands, Sweden, Switzerland, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 29, 2005
Enrollment StartMay 1, 2005
Primary CompletionSep 1, 2007
Study CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 20.8 years ago

Interventions

SU011248 (sunitinib)drug

37.5 mg/day, oral, continuous daily dosing