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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003368-39 | EudraCT Number | ||
| U1111-1132-9056 | Other Identifier | UTN |
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Primary Objective:
- To assess the safety, tolerability and plasma pharmacokinetics (PK) of SAR245408 given once daily as a tablet formulation of polymorph E in subjects with solid tumors or lymphoma.
Screening: 1 to 28 days Study treatment period: two 28-day cycles (56 days) End-of-treatment visit: no later than 7 days after the last study drug administration Subjects not eligible for treatment continuation after Cycle 2 will be followed up for safety; a follow-up visit will be performed within 30 ± 3 days after the last study drug administration Subjects eligible for treatment continuation after Cycle 2 will be offered the opportunity to enroll in the treatment-extension study TED12414.
Total duration of study participation for each patient: 58 to 118 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAR245408 polymorph E tablets | Experimental | Escalating doses of SAR245408 polymorph E tablets, once daily dosing with morning meal every day for two 28-days cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAR245408 | Drug | Pharmaceutical form: tablet Route of administration: oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicities | Up to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with treatment-emergent adverse events | From first dose of SAR245408 up to 30 days after the last dose | |
| Maximum SAR245408 plasma concentration | Days 1, 2, 8, 15, 29 and 30 | |
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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 056001 | Leuven | 3000 | Belgium |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C581157 | XL147 |
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| Area under the SAR245408 plasma concentration versus time curve |
| Days 1, 2, 8, 15, 29 and 30 |