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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003672-39 | EudraCT Number | ||
| cabazL06470 | Other Identifier | Sanofi |
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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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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 clinical profiles, and varying patterns of tumor spread. The optimal cytotoxic treatment for this group of patients remains uncertain. Single agents which are most effective include doxorubicin and ifosfamide, but objective response rates and progression-free survival times remain modest. There is clearly a need to improve treatment options for liposarcoma. Eribulin, a antimicrotubule agent that targets the protein tubulin in cells, interfering with cancer cell division and growth , has demonstrated activity in STS. Therefore, it is reasonable to explore whether other anti-microtubule agent like cabazitaxel have a role in STS. Cabazitaxel has been shown to be a relatively safe, effective and tolerated. This drug has been approved by FDA for prostate cancer. The main objective of this trial is to determine whether cabazitaxel demonstrate sufficient antitumor activity for liposarcoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cabazitaxel | Experimental | INN: Cabazitaxel Cabazitaxel will be administered at a dose of 25 mg/m² by intravenous infusion, over 1 hour, on day 1 of each 21 day cycle. Treatment should be administered until disease progression, unacceptable toxicity or patient's refusal. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cabazitaxel | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | The primary endpoint will be progression free survival, assessed at 12 weeks after start of treatment | 3 years from first patient in |
| Measure | Description | Time Frame |
|---|---|---|
| Time to progression | 3 years from first patient in | |
| Progression free survival | 3 years from first patient in | |
| Overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Larry Hayward, MD | Western General Hospital, Edinburgh, United Kingdom | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Antwerpen (117) | Antwerp | Belgium | ||||
| Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet (101) |
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| ID | Term |
|---|---|
| D008080 | Liposarcoma |
| ID | Term |
|---|---|
| D018205 | Neoplasms, Adipose Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C552428 | cabazitaxel |
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| 3 years from first patient in |
| Objective tumor response | Objective tumor response as defined by RECIST 1.1 | 3 years from first patient in |
| Time to onset of response | Time to onset of response will be measured for patients achieving an objective response | 3 years from first patient in |
| Duration of response | Duration of response will be measured for patients achieving an objective response | 3 years from first patient in |
| Occurence of adverse events | This study will use the International Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, for adverse event reporting. | 3 years from first patient in |
| Brussels |
| Belgium |
| CHU de Dijon - Centre Georges-Francois-Leclerc (229) | Dijon | 21079 | France |
| Centre Leon Berard (227) | Lyon | France |
| Assistance Publique - Hopitaux de Marseille - Hôpital de La Timone (287) | Marseille | France |
| Fondazione IRCCS Istituto Nazionale dei Tumori (704) | Milan | Italy |
| Istituto Oncologico Veneto IRCCS - Ospedale Busonera (3908) | Padova | Italy |
| Clatterbridge Centre for Oncology NHS Trust - Clatterbridge Cancer Centre NHS Foundation Trust (659) | Bebington | United Kingdom |
| Western General Hospital | Edinburgh | EH4 2XU | United Kingdom |
| Royal Marsden Hospital - Chelsea, London (613) | London | United Kingdom |
| The Christie NHS Foundation Trust (610) | Manchester | United Kingdom |
| D012509 | Sarcoma |