PDGFRB and mTOR (or S6 or 4BP1) positive advanced chordoma MedDRA version: 9.1 Level: LLT Classification code 10039492 MedDRA version: 9.1 Level: PT Classification code 10006007 MedDRA version: 9.1 Level: HLT Classification code 10039498
Conditions
Interventions
Trade Name: GLIVEC
Pharmaceutical Form: Tablet
Current Sponsor code: STI571
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Product Name: everolimus
Product C
Sponsors
ISTITUTO NAZIONALE PER LA CURA TUMORI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: diagnosis of chordoma PDGFRB/PDGFB e mTOR (or S6 or 4BP1) expression advanced disease Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: No prior, or ongoing other malignancy, except adequately treated basal cell or squamous cell, skin cancer, in situ cervical cancer or adequately treated cancer with eradicative intent. Patients receiving chemotherapy, immunotherapy, radiation therapy or any other investigational agent within 4 weeks of the first dose of study drug. Imatinib in monotherapy is allowed Patients with known history of hypersensitivity against imatinib or everolimus (or other rapamycin analogs), or to their excipients. Patients receiving systemic treatment with immunosuppressive agent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: response rate according to Choi criteria;Secondary Objective: progression free survival, overall survival, clinical benefit;Primary end point(s): Overall tumor Response Rate, according to Choi criteria at 6 months | — |
Countries
Italy
Outcome results
None listed