At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 105 enrolled
Drug / intervention
Sunitinib Malate (SU011248)drug
Likely dose
Sunitinib Malate (SU011248) 50 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 Single-Arm, Open-Label, Multi-Center, Phase Iv, Safety And Efficacy Study Of Sunitinib Malate As First-Line Systemic Therapy In Chinese Patients With Metastatic Renal Cell Carcinoma (Post Approval Commitment Study)
In Brief
A Phase 4 clinical trial evaluating Sunitinib Malate (SU011248) for Carcinoma, Renal Cell. Completed, enrolled 105 participants across 11 sites.
Detailed Summary
To investigate safety and efficacy of single agent sunitinib malate as first-line systemic therapy in Chinese patients with metastatic renal cell carcinoma.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Renal Cell
CountriesChina
Collaborators--
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 2008
Enrollment StartJul 2008
Primary CompletionAug 2011
TodayJul 2026
First PostedJun 27, 2008
Enrollment StartJul 1, 2008
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 18.0 years ago
Interventions
Sunitinib Malate (SU011248)drug
Subjects will receive treatment with sunitinib in repeated 6-week cycles (4 weeks on, 2 weeks off), at a starting dose of 50 mg.