Phase II study on imatinib in combination with RAD001 in advanced chordoma - imatinib in combination with RAD001 in advanced chordoma
- Conditions
- PDGFRB and mTOR (or S6 or 4BP1) positive advanced chordomaMedDRA version: 9.1Level: LLTClassification code 10039492MedDRA version: 9.1Level: PTClassification code 10006007MedDRA version: 9.1Level: HLTClassification code 10039498
- Registration Number
- EUCTR2010-021755-34-IT
- Lead Sponsor
- ISTITUTO NAZIONALE PER LA CURA TUMORI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method