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.
- Conditions
- bone cancerchondrosarcoma10040778
- Registration Number
- NL-OMON47217
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 23
- 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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Time to progression after start of treatment according to RECIST 1.1 </p><br>
- Secondary Outcome Measures
Name Time Method <p>- Translational exploratory tumour pharmacodynamic analysis<br /><br><br /><br>- Toxicity according to CTC version 4.0<br /><br><br /><br>- Objective response defined as a partial or complete response occurring after<br /><br>start of treatment according to RECIST1.1<br /><br><br /><br>- Overall survival from start of treatment until death<br /><br><br /><br>- Time to progression during sirolimus/cyclophosphamide treatment (TTP2)<br /><br>divided by time to progression before start of this treatment TTP1 (=growth<br /><br>modulation index)</p><br>