Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1123-1488 | Other Identifier | UTN |
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
Primary Objective:
- To evaluate the safety and tolerability of SAR245409 tablets administered once or twice a day in patients with solid tumors or lymphoma.
Secondary Objectives:
The total study duration per patient will be 58 to 128 days and will include a screening period (1 to 28 days), a food interaction investigation period (when applicable; 4 to 11 days), two 28-day treatment cycles (56 days), an end-of-treatment visit (within 7 days after the last SAR245409 administration) and a follow-up visit (within 30 ± 3 days after the last SAR245409 administration).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Once daily dosing | Experimental | escalating doses, once daily dosing every day, no eating for 2 hours prior and 1 hour after dose |
|
| Twice daily dosing | Experimental | escalating doses, twice daily dosing every day, no eating for 2 hours prior and 1 hour after dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAR245409 | 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 SAR245409 until 30 days after the last dose | |
| Maximum SAR245409 plasma concentration | Cycle 1 Days 1, 2, 8, 15, and 28, and Cycle 2 Day 1 |
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 |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 840001 | Detroit | Michigan | 48201 | United States | ||
| Investigational Site Number 840002 |
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C576808 | XL765 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Area under the SAR245409 plasma concentration versus time curve | Cycle 1 Days 1, 2, 8, 15, and 28, and Cycle 2 Day 1 |
| Ratio of maximum SAR245409 plasma concentration between fed and fasted dosing | Days 1, 2, 3, and 4 of the food interaction period |
| Ratio of area under the SAR245409 plasma concentration versus time curve between fed and fasted dosing | Days 1, 2, 3, and 4 of the food interaction period |
| New Brunswick |
| New Jersey |
| 08903 |
| United States |
| Investigational Site Number 840003 | Dallas | Texas | 75230 | United States |