Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT 2007-004868-41 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective is to determine the maximum tolerated dose (MTD) of SAR3419 according to the dose limiting toxicities (DLTs) observed when administered as a single agent once weekly.
Secondary objectives are:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAR3419 | Drug | administered by intravenous infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of DLT(s) at each dose level | during the initial 3-week period of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative DLT(s) | over the entire period of treatment | |
| Incidence of Adverse Events and laboratory abnormalities | study period | |
| Tumor response (complete response, partial response) and duration of the response |
Not provided
Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bertrand COIFFIER, Professor of Hematology | Centre Hospitalier Lyon Sud, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Investigational Site Number 250004 | Créteil | 94010 | France | |||
| Sanofi-Aventis Investigational Site Number 250006 |
Not provided
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C569646 | coltuximab ravtansine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| study period |
| Pharmacokinetics parameters | Study period |
| Lille |
| 59037 |
| France |
| Sanofi-Aventis Investigational Site Number 250001 | Pierre-Bénite | 69495 | France |
| Sanofi-Aventis Investigational Site Number 250005 | Rennes | 35033 | France |
| Sanofi-Aventis Investigational Site Number 250003 | Rouen | 76038 | France |
| Sanofi-Aventis Investigational Site Number 250002 | Villejuif | 94805 | France |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |