Clinical study testing the combination of sirolimus and cyclophosphamiodein chondrosarcoma and myxoid liposarcoma patients
- Conditions
- Conventional chondrosarcomaMyxoid liposarcoma with PIK3CA mutation or PTEN lossMesenchymal or dedifferentiated chondrosarcomaClear cell chondrosarcomaTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-005155-32-NL
- Lead Sponsor
- eiden University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 108
-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 chondrosardoma
-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
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 93
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15
-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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate treatment efficacy by time to progression according to RECIST 1.1;Secondary Objective: - To evaluate the safety and tolerability of the sirolimus and<br>cyclophosphamide combination<br>- To determine the median progression free survival after start of<br>treatment till disease progression<br>- To determine the overall survival after start of treatment till death<br>- To evaluate the treatment efficiency by growth modulation index;Primary end point(s): Time to progression after start of treatment according to RECIST 1.1;Timepoint(s) of evaluation of this end point: Patients will be evaluated with CT-scan every 8 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Translational exploratory tumour pharmacodynamic analysis<br>- Toxicity according to CTC version 4.0<br>- Objective response defined as a partial or complete response occurring after start of treatment according to RECIST1.1<br>- Overall survival from start of treatment until death<br>- Time to progression during sirolimus/cyclofosfamide treatment (TTP2) divided by time to progression before start of this treatment TTP1 (=growth modulation index);Timepoint(s) of evaluation of this end point: 1. every 4 weeks on outpartient clinic visit<br>2. every 8 weeks with CT-scan<br>