Imatinib Mesylate in Patients With Refractory Desmoplastic Small Round Cell Tumors
Phase 1
Completed
- Conditions
- Refractory Desmoplastic Small Round Cell Tumors
- Interventions
- Registration Number
- NCT00417807
- Lead Sponsor
- Novartis Pharmaceuticals
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Gleevec/Glivec Imatinib mesilate -
- Primary Outcome Measures
Name Time Method Overall tumor response rates Assessed every 3 months An imaging technique (CT scan or MRI) determined tumor response according to RECIST criteria.
- Secondary Outcome Measures
Name Time Method Explore how Imatinib cooperated with other treatment modatilities Survival data was collected until death Recorded survival after treatment and other associated treatment modalities.
Safety and tolerability Safety data collected until patients were no longer in study Conversion rate to surgical resectability After best tumor response. Assessed actual resectability rate after therapy compared to resectability before therapy.
Mutational analysis of molecular targets of imatinib (at any time during the study) At any time during the study
Trial Locations
- Locations (2)
Novartis Investigative Site
🇮🇹Torino, Italy
Novartis Investigative Stie
🇮🇹Vatania, Italy