Ph II Cabazitaxel DD Liposarcoma

Inclusion criteria

• Local diagnosis of dedifferentiated liposarcoma
• Age 18-75 yrs
• WHO performance status 0-1
• Radiological or histological diagnosis of inoperable locally advanced or metastatic disease, with evidence of disease progression within the past 6 months
• Clinically and/or radiographically documented measurable disease within 21 days prior to randomization.At least one site of disease must be unidimensionally measurable according to RECIST 1.1.
• One previous chemotherapy regimen for locally advanced or metastatic dedifferentiated liposarcoma (this could include pre-operative chemotherapy for primary disease if subsequent complete resection was not achieved).
• Adequate haematological, renal and hepatic function
• Birth control measures
• Estimated life expectancy > 3 months
• Related adverse events from previous therapies ≤ Grade 1
• Written informed consent

Exclusion criteria

• More than 1 prior molecularly targeted therapy (e.g. CDK4 inhibitor). Any prior such therapy must be completed at least 4 weeks before randomization.
• Symptomatic CNS metastases
• Previous encephalopathy of any cause or other significant neurological condition
• Concurrent or planned treatment with strong inhibitors or inducers of cytochrome P450 3A4/5
• Pregnancy
• inflammation of the urinary bladder (cystitis)
• Other invasive malignancy within 5 years (exceptions of non-melanoma skin cancer, localized cervical cancer, localized and presumably cured prostate cancer or adequately treated basal or squamous cell skin carcinoma)
• Significant cardiac disease
• Uncontrolled severe illness or medical condition, other than DD liposarcoma
• Hypersensitivity to taxanes or their excipients