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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000073

Enrollment

Registered

2005-08-22

Start date

2005-03-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcoma with c-kit or PDGFR expression by immunohistochemistry

Interventions

Imatinib 600mg once a day

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: 1) controlable or active infection 2) pregnacy or lactation 3) brain metastasis with clinical symptom

Design outcomes

Primary

Measure	Time frame
Response rate in patients with Imatinib 600mg/day	—

Secondary

Measure	Time frame
1) Response rate in patients with Imatinib 800mg/day 2) Adverse events 3) Time to progression 4) To evaluate relationships between response and profile of gene expression 5) Pharmacokinetics in adolescence patients	—

Countries

Japan

Contacts

Public ContactMasashi Ando, MD

Office of Imatinib phase2 study Dept of Medical Oncology, National Cancer Center Hospital

mandoh@ncc.go.jp03-3542-2511

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026