Open-label Trial of Imatinib Mesylate in Patients With Refractory Desmoplastic Small Round Cell Tumors (DSRCT) Expressing PDGF-R

Novartis Pharmaceuticals2 sites in 1 country9 target enrollmentAugust 2005

ConditionsRefractory Desmoplastic Small Round Cell Tumors

InterventionsImatinib mesilate

DrugsImatinib mesilate

Overview

Phase: Phase 1
Intervention: Imatinib mesilate
Conditions: Refractory Desmoplastic Small Round Cell Tumors
Sponsor: Novartis Pharmaceuticals
Enrollment: 9
Locations: 2
Primary Endpoint: Overall tumor response rates
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

An open-label, non-comparative study conducted to investigate the activity and safety of imatinib mesylate in refractory desmoplastic small round cell tumors expressing PDGF-R. Patients will be treated up to 12 months, or to disease progression. Tumor will be evaluated according to Recist criteria

Registry

clinicaltrials.gov

Start Date

August 2005

End Date

June 2009

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

Gleevec/Glivec

Intervention: Imatinib mesilate

Outcomes

Primary Outcomes

Overall tumor response rates

Time Frame: Assessed every 3 months

An imaging technique (CT scan or MRI) determined tumor response according to RECIST criteria.

Secondary Outcomes

Explore how Imatinib cooperated with other treatment modatilities(Survival data was collected until death)
Safety and tolerability(Safety data collected until patients were no longer in study)
Conversion rate to surgical resectability(After best tumor response.)
Mutational analysis of molecular targets of imatinib (at any time during the study)(At any time during the study)