EUCTR2013-005155-32-ES
Active, not recruiting
Phase 1
A phase 2, single arm, multi center trial evaluating the efficacy of the combination of sirolimus and cyclophosphamide in metastatic or unresectable myxoid liposarcoma and chondrosarcoma. - COSYMO
Grupo Español de Investigación en Sarcomas (GEIS)0 sitesMay 8, 2017
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Conventional chondrosarcomaMyxoid liposarcoma with PIK3CA mutation or PTEN lossMesenchymal or dedifferentiated chondrosarcoma
- Sponsor
- Grupo Español de Investigación en Sarcomas (GEIS)
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-Pathologically proven conventional chondrosarcoma
- •\-Or pathologically proven myxoid liposarcoma with PIK3CA mutation or PTEN loss
- •\-Or pathologically proven mesenchymal or dedifferentiated chondrosarcoma
- •\-Patients of 18 years and up
- •\-Documented radiographic progression of disease according to RECIST 1\.1 criteria in last 6 months
- •\-Adequate bone marrow function (Hb \= 6\.0 mmol/L, absolute neutrophil count \= 1\.5 x 109/L, platelets \= 80 x 109/L)
- •\-Availability of archival tumor material for central review
- •\-Written signed informed consent
- •\-Ability to adhere to the study visits and all protocol requirements
- •Are the trial subjects under 18? no
Exclusion Criteria
- •\-Previously treated with an mTOR inhibitor
- •\-Known to be allergic to cyclophosphamide
- •\-Life expectancy of less than 3 months
- •\-No measurable lesions according to RECIST 1\.1
- •\-ECOG Performance status \>2
- •\-Major surgery less than 4 weeks prior to start of treatment
- •\-Known human immunodeficiency virus (HIV) positivity
- •\-A decreased renal function with calculated GFR \< 30 ml/min
- •\-Systemic anti\-cancer therapy within 28 days prior to the first dose of study drug , or radiotherapy to an index (or target) lesion within 21 days prior to the first dose of study drug
- •\-Pregnant or lactating women
Outcomes
Primary Outcomes
Not specified
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