Trial intelligence / Profile preview

Imatinib in Refractory DSRCT Expressing PDGF-R

NCT00417807Phase 2

Key facts

Status: Completed
Start: Aug 2005
Primary completion: Jun 2009
Countries: 1
Sponsor: Novartis
Modality: Small Molecules

Drugs: imatinib
Conditions: desmoplastic small round cell tumor (DSRCT)

Overview

Phase 2, open-label, single-arm trial of imatinib in desmoplastic small round cell tumor (DSRCT), sponsored by Novartis. Primary endpoint: Overall tumor response rates at 3 months. Started Aug 2005; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

Gleevec/Glivec
Imatinib mesylate

Who it enrols

Patients > 16 years with refractory DSRCT expressing PDGF-R, unresponsive to conventional therapy, with adequate organ function.

Endpoints

Primary

Overall tumor response rates3 months

Secondary

Survivaluntil death
Safety and tolerabilityduring study
Conversion rate to surgical resectabilityafter best tumor response
Mutational analysis of molecular targets of imatinibany time

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