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SAR302503 · 8 trials · 6 indications
| Arm | Type | Description |
|---|---|---|
| SAR302503 300mg | EXPERIMENTAL | SAR302503 will be self-administered, orally, once daily, as a single agent, in consecutive, 28-day cycles at the dose level of 300mg. SAR302503 will be taken on an empty stomach at approximately the same time each day |
| SAR302503 400 mg | EXPERIMENTAL | SAR302503 will be self-administered, orally, once daily, as a single agent, in consecutive, 28-day cycles at the dose level of 400 mg. SAR302503 will be taken on an empty stomach at approximately the same time each day |
| SAR302503 500 mg | EXPERIMENTAL | SAR302503 will be self-administered, orally, once daily, as a single agent, in consecutive, 28-day cycles at the dose level of 500 mg. SAR302503 will be taken on an empty stomach at approximately the same time each day |
| SAR302503 100 mg | EXPERIMENTAL | once daily X 28 days |
| SAR302503 200 mg | EXPERIMENTAL | once daily X 28 days |
| SAR302503 600 mg | EXPERIMENTAL | once daily X 28 days |
| SAR02503 300 mg qd | EXPERIMENTAL | daily X 28 days |
| SAR302503 400 mg qd | EXPERIMENTAL | daily X 28 days |
| SAR302503 500 mg qd | EXPERIMENTAL | daily X 28 days |
| Single-sequence | EXPERIMENTAL | SAR302503 Placebo (1 day)-SAR302503 (500 mg, oral, qd, 14 days) |
| SAR302503 | EXPERIMENTAL | single treatment with oral dose up to 300 mg of SAR302503 |
| Segment 1 | EXPERIMENTAL | two single doses of omeprazol/metoprolol/midazolam on day-1 and day 15 without food, SAR302503 500 mg once daily without food for 15 days |
| Segment 2 | EXPERIMENTAL | SAR302503 500 mg once daily without food in 28-day per cycle |
| 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| SAR302503 | DRUG | Pharmaceutical form:Capsule Route of administration: oral |
| SAR302503 (TG101348) | DRUG | Pharmaceutical form:capsule Route of administration: oral |
| Placebo SAR302503 | DRUG | Pharmaceutical form:capsule Route of administration: oral |
| Panolosetron | DRUG | Pharmaceutical form:solution Route of administration: intravenous |
| omeprazol | DRUG | Pharmaceutical form:capsule Route of administration: oral |
| metoprolol | DRUG | Pharmaceutical form:tablet Route of administration: oral |
| midazolam | DRUG | Pharmaceutical form:solution Route of administration: oral |
Inclusion criteria : * Diagnosis of primary or post-polycythemia vera or post-essential thrombocythemia myelofibrosis * Myelofibrosis classified as high-risk or intermediate-risk level 2 * Enlarged spleen, palpable at least 5 cm below costal margin * Active symptoms of myelofibrosis * At least 20 y...
SAR302503 is an investigational small molecule being developed by Bristol-Myers Squibb Company (BMY) for oncology indications. It has been studied in patients with solid tumors, myelofibrosis, hepatic impairment, malignant neoplasms, hematopoietic neoplasms, and renal impairment. The drug has completed Phase 1 trials and is currently in Phase 2 development.
SAR302503 is being studied for use in solid tumors, myelofibrosis, hepatic impairment, malignant neoplasms, hematopoietic neoplasms, and renal impairment. It is an investigational oncology drug that has completed Phase 1 trials and is currently in Phase 2 development. It has not been approved by the FDA.
SAR302503 is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in various oncology and organ impairment conditions.
SAR302503 is currently in Phase 2 development. It has completed two Phase 1 trials, with a total of 111 patients enrolled across all studies. The drug is investigational and has not received FDA approval.
SAR302503 has completed four clinical trials: NCT01585623, a drug interaction study in solid tumor patients; NCT01762462, a pharmacokinetic study in hepatic impairment; NCT01763190, a pharmacokinetic study in renal impairment; and NCT01836705, an ECG activity study in patients with malignant neoplasms. All trials were Phase 1 and are now completed.
SAR302503 is not known to have alternative names. It is being developed by Bristol-Myers Squibb Company under this identifier. The drug is a small molecule in the oncology therapeutic area, currently in Phase 2 clinical development.