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Also known as SAR245408 (XL147)
SAR245408 · 4 trials · 2 indications
Any untoward medical occurrence in a participant who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. Serious adverse event (SAE): any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial/prolonged in-patient hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect/considered as medically important event. TEAEs: AEs that developed/worsened/became serious during on-treatment period (time from IMP until 30 days after last dose of any IMP). Any TEAE included participants with both SAE \& non-SAEs. TEAE included participants with any treatment-emergent SAE (TESAE). TEAEs that led to death, dose reduction and/or delay, discontinuation \& AEs related to treatment were reported. Grades (3=severe, 4=life-threatening/disabling) represents severity of AEs.
Hematological parameters assessed were anemia, neutropenia and thrombocytopenia. Parameters were assessed as per the National Cancer Institute Common Terminology Criteria for Adverse Experience version 4.03 (NCI-CTCAE v 4.03), where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs.
Biochemical parameters assessed were hyperglycemia, aspartate aminotransferase (ASAT) increased, alanine aminotransferase (ALAT) increased, hyperbilirubinemia, hypocalcemia, creatinine increased. Parameters were assessed as per the NCI-CTCAE v 4.03, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs.
| Arm | Type | Description |
|---|---|---|
| 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 |
| SAR245408: Monotherapy | EXPERIMENTAL | Participants received SAR245408 400 milligrams (mg) once daily or at the established dose as monotherapy in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245408 were available (up to 1959 days). |
| SAR245408: Combination Regimen | EXPERIMENTAL | Participants received SAR245408 400 mg once daily or at the established dose as combination regimen in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245408 were available (up to 1959 days). Commercially available drugs were used as combination medications with SAR245408 (depending on the parental study, the following drugs were used in combination with SAR245408: paclitaxel and carboplatin, letrozole, trastuzumab, paclitaxel and trastuzumab). |
| SAR245409: Monotherapy | EXPERIMENTAL | Participants received SAR245409 50 mg twice daily or at the established dose as monotherapy in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245409 were available (up to 1917 days). |
| SAR245409: Combination Regimen | EXPERIMENTAL | Participants received SAR245409 50 mg twice daily or at the established dose as combination regimen in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245409 were available (up to 1917 days). Commercially available drugs were used as combination medications with SAR245409 (depending on the parental study, the following drugs were used in combination with SAR245409: letrozole, temozolomide, rituximab, bendamustine and rituximab). |
| SAR245408 | EXPERIMENTAL | single cohort: SAR245408 administered once daily |
| Dose Escalation | EXPERIMENTAL | Dose escalation phase The starting dose of SAR245408 will be 25-mg once daily (up to 200-mg). The starting dose of MSC1936369B will be 15- mg once daily (up to 90-mg) |
| Name | Type | Description |
|---|---|---|
| SAR245408 | DRUG | Pharmaceutical form: tablet Route of administration: oral |
| SAR245409 | DRUG | Pharmaceutical form: capsule or tablet Route of administration: oral |
| SAR245408 (XL147) | DRUG | Pharmaceutical form:capsule and tablet Route of administration: oral |
| MSC1936369B | DRUG | Pharmaceutical form:capsule Route of administration: oral |
Inclusion criteria : * Solid tumor that is metastatic or unresectable, or relapsed or refractory lymphoma (including chronic lymphocytic leukemia/small lymphocytic lymphoma), for which standard therapies are no longer effective or there are no therapies known to prolong survival or patient cannot t...
SAR245408 is an investigational small molecule developed by Sanofi for the treatment of malignant neoplasms and solid tumors. It is an oncology candidate that has been studied in Phase 1 clinical trials. SAR245408 is also known as XL147.
SAR245408 has been studied in patients with malignant neoplasms, including solid tumors and lymphoma. All clinical testing has been in the oncology setting, and the compound remains investigational rather than approved for any indication.
SAR245408 is developed by Sanofi, which trades under the ticker SNY. Sanofi sponsored the Phase 1 clinical program evaluating the compound in patients with solid tumors and lymphoma.
SAR245408 is in Phase 1 development. All four listed trials were Phase 1 studies, and all have completed. The drug is investigational and has not been approved by the FDA for any indication.
SAR245408 has been evaluated in completed Phase 1 trials including NCT01943838 in Belgium, NCT01587040 across the United States, Belgium, France and Spain, NCT01392924 in Japan, and NCT01357330 in the United States. Total enrollment across these studies was 89 patients.
Yes, SAR245408 is also known as XL147. The two names refer to the same investigational compound, and the Phase 1 trial NCT01357330 lists it as oral SAR245408 (XL147) in patients with locally advanced or metastatic solid tumors.