CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 36 enrolled
Drug / intervention
Sunitinib malate (SU011248)drug
Likely dose
Not stated in 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.

Search/NCT00457743
NCT00457743Phase 2Completed
CompareCT.gov

A Phase I/II Study of Sunitinib Malate (SU011248) In The Treatment of Patients With Malignant Gastrointestinal Stromal Tumor (GIST) Previously Treated by Imatinib Mesylate.

Pfizer·interventional·Posted Apr 6, 2007·Updated Nov 13, 2009

In Brief

A Phase 2 clinical trial evaluating Sunitinib malate (SU011248) for Gastrointestinal Stromal Tumors. Completed, enrolled 36 participants across 4 sites.

Detailed Summary

Phase I;To investigate the clinically recommended dose of Sunitinib malate (SU011248) following multiple oral dosing in the first cycle (4 consecutive weeks and 2 weeks rest) by reviewing the safety and tolerability. Phase II;To determine the objective tumor response and the safety of Sunitinib malate (SU011248) at the clinically recommended dose.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastrointestinal Stromal Tumors
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 6, 2007
Enrollment StartJan 1, 2005
Primary CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 19.2 years ago

Interventions

Sunitinib malate (SU011248)drug

SU011248