Status:
COMPLETED
Ph II Cabazitaxel DD Liposarcoma
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Collaborating Sponsors:
Sanofi
Conditions:
Dedifferentiated Liposarcoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Soft tissue sarcomas (STS) are a rare group of malignant heterogenous tumors (\> 50 histological subtypes, including liposarcoma, the commonest subtype of STS) with distinct genetic, pathological and ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01913652
Start Date
October 1 2014
End Date
December 1 2020
Last Update
September 14 2021
Active Locations (11)
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1
Universitair Ziekenhuis Antwerpen (117)
Antwerp, Belgium
2
Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet (101)
Brussels, Belgium
3
CHU de Dijon - Centre Georges-Francois-Leclerc (229)
Dijon, France, 21079
4
Centre Leon Berard (227)
Lyon, France