malignant mesothelioma expressing either PDGFR-beta or c-kit MedDRA version: 9.1 Level: LLT Classification code 10027408 Term: Mesothelioma malignant advanced MedDRA version: 9.1 Level: LLT Classification code 10027411 Term: Mesothelioma malignant recurrent
Conditions
Interventions
Trade Name: GLIVEC*24CPS 100MG
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: IMATINIB MESILATO
CAS Number: 220127-57-1
Current Sponsor code: STI571
Concentration unit: mg milligram(s)
Conce
Sponsors
Gruppo Italiano Mesotelioma (G.I.Me.)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: age of > 18 years and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: co-existing tumors of different histologic origin, except non melanomatous localized skin cancer and/or in situ cervical carcinoma, a history of earlier tumors of different histologic origin being in complete remission since less than 5 years, unresolved toxicity from prior antitumor treatment(s), primary peritoneal mesothelioma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: efficacy, i.e., response rate to study drugs;Secondary Objective: duration of response time to progression toxicity profile overall survival;Primary end point(s): overall response rate | — |
Countries
Italy
Outcome results
None listed