Phase2 Study of Glivec (imatinib mesylate, formerly known as STI571) in Patients with Relapsed or Refractory Sarcomas with c-kit or PDGFR Expressio

Phase 2

Completed

• Conditions: Sarcoma with c-kit or PDGFR expression by immunohistochemistry

• Registration Number: JPRN-jRCT1091220003
• Lead Sponsor: Office of Imatinib phase 2 study

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-12-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1) Histologically confirmed metastatic or unresectable locally advanced sarcomas (excluding gastrointestinal stromal tumor) Eligible subtypes: Ewing's sarcoma / Primitive neuroectodermal tumor(PNET); Synovial sarcoma; Neuroblastoma; Desmoplastic small round cell tumor; Leiomyosarcoma; Rabdomyosarcoma; Liposarcoma; Fibrosarcoma; Angiosarcoma; Malignant fibrous histiocytoma; Malignant peripheral nerve sheath tumor; Osteosarcom; Alveolar soft part sarcoma; Epitheloid sarcom; Clear cell sarcoma
2) c-kit positive tumor(CD117 expression on immunohistochmial staining)
3) Tumor tissue blocks must be available
4) Relapsed or refractory to comventional chemotherapy
5) At least 1 measurable lesion: At least 20mm by conventional techniques or at least 10mm by spiral CT scan
6) Chemotherapy: at least 4 weeks since prior chemotherapy and no concurrent therapy
7) Age: 12<= and <75
8) Written informed consent

Exclusion Criteria

1) uncontrolable or active infection
2) pregnacy or lactation
3) brain metastasis with clinical symptom

Study & Design

• Study Type: Interventional
• Study Design: Not specified