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Also known as SAR302503 (TG101348)
SAR302503 · 8 trials · 6 indications
Best response categories per IWG-MRT response criteria across studies TED12037 and TED12015 combined. Responses were assessed using IWG-MRT criteria and categorized as complete remission (CR), partial remission (PR), clinical improvement (CI), stable disease (SD), or progressive disease (PD). CR and PR reflect disease modification with resolution or partial resolution of disease features; CI reflects improvement in key clinical parameters without full remission; SD indicates no meaningful change; and PD indicates disease worsening.
| 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 studied in oncology for myelofibrosis and other hematopoietic neoplasms, as well as solid tumors. It has also been evaluated in pharmacokinetic studies in patients with renal impairment and hepatic impairment. It is not approved and remains in clinical development.
SAR302503 is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is the sponsor of the clinical trials evaluating the drug in myelofibrosis, solid tumors, and organ impairment populations.
SAR302503 is in Phase 2 development. The highest phase among its completed trials is a Phase 2 study in Japanese patients with intermediate-2 or high risk primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis with splenomegaly.
Yes, SAR302503 is also known as TG101348. Both names refer to the same investigational small molecule developed by Bristol-Myers Squibb. Searches for either name point to the same drug candidate and its clinical program.
SAR302503 has been studied in completed trials including NCT01692366, a Phase 2 study in Japanese patients with myelofibrosis; NCT01836705, a Phase 1 ECG study in solid tumors; NCT01763190, a Phase 1 pharmacokinetic study in renal impairment; and NCT01762462, a Phase 1 pharmacokinetic study in hepatic impairment.
SAR302503 is not approved and remains an investigational drug in clinical development. Its trials are listed as completed, and no regulatory approval has been granted for any indication. It has been studied in myelofibrosis, solid tumors, renal impairment, and hepatic impairment.