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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001616-57 | EudraCT Number | ||
| U1111-1118-6417 | Other Identifier | UTN |
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Primary Objective:
- To evaluate the efficacy of SAR245409 as determined by the objective response rate (ORR) in patients with 1 of following relapsed or refractory lymphoma or leukemia subtypes: mantle cell lymphoma (MCL), follicular lymphoma (FL), chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), or diffuse large B cell lymphoma (DLBCL)
Secondary Objectives:
There is a 21 day screening period followed by 28 day cycles. Patients will continue to receive SAR245409 as long as there is clinical benefit or until a study withdrawal criterion is met. The last posttreatment visit will be 30 days after the last dose or until IMP-related toxicities have resolved or are deemed irreversible, whichever is later.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mantle cell | Experimental | 50 mg twice daily: no eating for 2 hours prior and 1 hour after dose |
|
| follicular lymphoma | Experimental | 50 mg twice daily: no eating for 2 hours prior and 1 hour after dose |
|
| CLL/SLL | Experimental | 50 mg twice daily:no eating for 2 hours prior and 1 hour after dose |
|
| Diffuse large B cell lymphoma | Experimental | 50 mg twice daily:no eating for 2 hours prior and 1 hour after dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAR245409 | Drug | Pharmaceutical form:capsule Route of administration: oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) as defined as the proportion of patients who experience complete response/remission (CR) or partial response/remission (PR) | 2 months to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) at 6 months | 6 months to 2 years |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 840012 | Los Angeles | California | 90033 | United States | ||
| Investigational Site Number 840104 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29550382 | Derived | Brown JR, Hamadani M, Hayslip J, Janssens A, Wagner-Johnston N, Ottmann O, Arnason J, Tilly H, Millenson M, Offner F, Gabrail NY, Ganguly S, Ailawadhi S, Kasar S, Kater AP, Doorduijn JK, Gao L, Lager JJ, Wu B, Egile C, Kersten MJ. Voxtalisib (XL765) in patients with relapsed or refractory non-Hodgkin lymphoma or chronic lymphocytic leukaemia: an open-label, phase 2 trial. Lancet Haematol. 2018 Apr;5(4):e170-e180. doi: 10.1016/S2352-3026(18)30030-9. Epub 2018 Mar 14. |
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| Fort Meyers |
| Florida |
| 33919 |
| United States |
| Investigational Site Number 840006 | Augusta | Georgia | 30912 | United States |
| Investigational Site Number 840011 | Maywood | Illinois | 60153 | United States |
| Investigational Site Number 840010 | Kansas City | Kansas | 66160-7321 | United States |
| Investigational Site Number 840013 | Lexington | Kentucky | 40536 | United States |
| Investigational Site Number 840007 | Paducah | Kentucky | 42002 | United States |
| Investigational Site Number 840004 | Boston | Massachusetts | 02115 | United States |
| Investigational Site Number 840015 | St Louis | Missouri | 63110 | United States |
| Investigational Site Number 840014 | Canton | Ohio | 44718 | United States |
| Investigational Site Number 840001 | Philadelphia | Pennsylvania | 19111 | United States |
| Investigational Site Number 840002 | Morgantown | West Virginia | 26506 | United States |
| Investigational Site Number 036002 | Clayton | 3168 | Australia |
| Investigational Site Number 036001 | Hobart | 7001 | Australia |
| Investigational Site Number 036005 | Kingswood | 2747 | Australia |
| Investigational Site Number 036003 | Perth | 6000 | Australia |
| Investigational Site Number 056003 | Brussels | 1000 | Belgium |
| Investigational Site Number 056002 | Ghent | 9000 | Belgium |
| Investigational Site Number 056001 | Leuven | 3000 | Belgium |
| Investigational Site Number 250002 | Montpellier | 34295 | France |
| Investigational Site Number 250001 | Pierre-Bénite | 69495 | France |
| Investigational Site Number 250004 | Rennes | 35033 | France |
| Investigational Site Number 250005 | Rouen | 76038 | France |
| Investigational Site Number 250003 | Villejuif | 94805 | France |
| Investigational Site Number 276003 | Frankfurt am Main | 60590 | Germany |
| Investigational Site Number 276002 | Jena | 07747 | Germany |
| Investigational Site Number 276001 | Ulm | 89081 | Germany |
| Investigational Site Number 528001 | Amsterdam | 1105 AZ | Netherlands |
| Investigational Site Number 528003 | Groningen | 9713 GZ | Netherlands |
| Investigational Site Number 528002 | Rotterdam | 3075 EA | Netherlands |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C576808 | XL765 |
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