CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 48 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/NCT00400569
NCT00400569Phase 2Completed

Phase II Open-Label Study of Sunitinib Malate (SU011248) in Adult Patients With Metastatic and/or Surgically Unresectable Soft Tissue Sarcoma

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted Nov 17, 2006·Updated Aug 28, 2012

In Brief

A Phase 2 clinical trial evaluating Sunitinib Malate (SU011248) for Liposarcoma and 3 related conditions. Completed, enrolled 48 participants across 1 site.

Detailed Summary

This is an open label single site Phase II clinical trial to identify a potentially promising therapy dose for Sunitinib malate. The study drug will be taken orally once daily on days 1 through 28 of each 42 day cycle. Treatment will be continued until there is either disease progression or cumulative/acute toxicity. All patients with unresectable or metastatic soft tissue sarcoma (STS): leiomyosarcoma, liposarcoma, fibrosarcoma, and malignant fibrous histiocytoma (MFH) seen at the Moffitt Cancer Center will be screened for eligibility to be enrolled in the study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsPfizer

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 17, 2006
Enrollment StartNov 1, 2006
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 19.6 years ago

Interventions

Sunitinib Malate (SU011248)drug

For each 6 week cycle, patients will take SU011248 every day in the morning for 4 weeks followed by a 2 week rest period.