NL-OMON47217RecruitingPhase 2
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
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 23
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •- Pathologically proven conventional chondrosarcoma
- •- Or pathologically proven myxoid liposarcoma with PIK3CA mutation or PTEN loss
- •- Or pathologically proven mesenchymal or dedifferentiated chondrosarcoma
- •- Or pathologically proven clear cell 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
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
- •- Other invasive malignancies diagnosed within the last 5 years, except non-melanoma skin cancer and localised cured prostate and cervical cancer
Investigators
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