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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1119-2906 | Other Identifier | UTN |
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Primary Objective:
- To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for SAR245409 when administered in combination with rituximab or bendamustine plus rituximab
Secondary Objectives:
All subjects will take SAR245409 twice daily. All subjects will receive SAR245409 as long as there is clinical benefit.
Combination therapy with SAR245409, bendamustine and rituximab , will be administered over a 28 day cycle for up to 6 to 8 cycles.
Subjects receiving the doublet combination , SAR245409 plus rituximab will receive weekly rituximab for 4 - 8 weeks. Monthly Rituximab may be continued beyond 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAR245409 + rituximab | Experimental | Subjects will receive oral SAR245409 twice daily continuously and weekly rituximab intravenously |
|
| SAR245409 + rituximab + bendamustine (iNHL, MCL) | Experimental | Subjects will receive oral SAR245409 twice daily continuously and monthly bendamustine intravenously. |
|
| SAR245409 + rituximab+ bendamustine (CLL) | Experimental | Subjects will receive oral SAR245409 twice daily continuously and monthly bendamustine and rituximab intravenously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAR245409 | Drug | Pharmaceutical form:capsule Route of administration: oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Identification Of Dose-Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD) | 4 weeks to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with treatment emergent adverse events | Time from receiving first dose of SAR245409 until 30 days after the last dose | |
| Pharmacokinetics (Cmax) of SAR245409 | up to 2 months | |
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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 840004 | Aurora | Colorado | 80045 | United States | ||
| Investigational Site Number 840006 |
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| Pharmacokinetics (tmax) of SAR245409 |
| up to 2 months |
| Pharmacokinetics (AUC0-12h) of SAR245409 | up to 2 months |
| Pharmacokinetics (Ctrough) of SAR245409 | up to 2 months |
| Pharmacokinetics (AUC) of bendamustine | up to 2 months |
| Pharmacokinetics (AUClast) of bendamustine | up to 2 months |
| Pharmacokinetics (Ceoi) of bendamustine | up to 2 months |
| Pharmacokinetics (tmax) of bendamustine | up to 2 months |
| Pharmacokinetics (Cl) of bendamustine | up to 2 months |
| Pharmacokinetics (Vss) of bendamustine | up to 2 months |
| Pharmacokinetics (AUC0-7h) of rituximab | up to 2 months |
| Pharmacokinetics (Ceoi) of rituximab | up to 2 months |
| Pharmacokinetics (tmax) of rituximab | up to 2 months |
| Efficacy as determined by objective response rate (ORR) | up to 4 years |
| Augusta |
| Georgia |
| 30912 |
| United States |
| Investigational Site Number 840002 | Charleston | South Carolina | 29406 | United States |
| ID | Term |
|---|---|
| D020522 | Lymphoma, Mantle-Cell |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| 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 |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C576808 | XL765 |
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