Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sapanisertib · 1 trial · 1 indication
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. An SAE is defined as an untoward medical occurrence, significant hazard, contraindication, side effect or precaution that at any dose: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
| Arm | Type | Description |
|---|---|---|
| Single-Agent QD Arm: Sapanisertib 3 mg | EXPERIMENTAL | Following Pharmacokinetic (PK) - Run in Period, sapanisertib 3 mg milled capsules, orally, once, daily in a 28-day Cycle, under fasted conditions, starting from Cycle 2 for up to 9 cycles. The dose of sapanisertib was modified based on safety and tolerability during each 28-day cycle. |
| Single-Agent QD Arm: Sapanisertib 4 mg | EXPERIMENTAL | Following PK Run-In Period, sapanisertib 4 mg milled capsules, orally, once, daily in a 28-day Cycle, under fasted conditions, for up to 13 cycles. |
| Combination Arm: Sapanisertib 4 mg + Paclitaxel 80 mg/m^2 | EXPERIMENTAL | Sapanisertib 4 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 12 cycles, and paclitaxel 80 mg/m\^2, intravenously (IV), on Days 1, 8, and 15 in 28-day Cycle, for up to 6 cycles. |
| Combination Arm: Sapanisertib 6 mg + Paclitaxel 80 mg/m^2 | EXPERIMENTAL | Sapanisertib 6 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 9 cycles, and paclitaxel 80 mg/m\^2, IV, on Days 1, 8, and 15 in 28-day Cycle, for up to 9 cycles. The dose of sapanisertib was modified based on safety and tolerability during each 28-day cycle. |
| Single-Agent QW Arm: Sapanisertib 20 mg | EXPERIMENTAL | Sapanisertib 20 mg, capsules milled API, QW in a 28-day Cycle, for up to 6 cycles. |
| Single-Agent QW Arm: Sapanisertib 30 mg | EXPERIMENTAL | Sapanisertib 30 mg, capsules, milled API, QW in a 28-day Cycle, for up to 10 cycles. |
| Name | Type | Description |
|---|---|---|
| Sapanisertib | DRUG | Sapanisertib capsules |
| Paclitaxel | DRUG | Paclitaxel injection |
Inclusion Criteria: 1. Age is ≥ 18 years, including males and females. 2. Has Advanced nonhematologic malignancies, with the exception of primary brain tumor, and have failed or are not eligible for standard of care therapy. History of brain metastasis may be allowed if all the following criteria a...
Sapanisertib is an investigational small molecule developed by Takeda Pharmaceutical Company Limited for advanced non-hematologic malignancies. It is an mTOR inhibitor studied as a single agent and in combination with paclitaxel. It remains in clinical development and has completed one Phase 1 trial.
Sapanisertib has been studied in adults with advanced non-hematologic malignancies. The single completed Phase 1 trial evaluated it as a single agent and in combination with paclitaxel in that patient population. It is investigational and has not been established as a marketed treatment.
Sapanisertib targets MTOR, also known as the mechanistic target of rapamycin. It is classified as an mTOR inhibitor, a small molecule that acts on this kinase. The completed Phase 1 study assessed its safety, tolerability, and pharmacokinetics in advanced non-hematologic malignancies.
Sapanisertib is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The compound is also identified in chemical databases by the ChEMBL ID CHEMBL3545097. Takeda conducted the Phase 1 study of the agent.
Sapanisertib is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. The study enrolled 61 participants and evaluated the drug as a single agent and in combination with paclitaxel in adults with advanced non-hematologic malignancies.
Sapanisertib has been studied in the completed Phase 1 trial NCT02412722, titled a safety, tolerability, and pharmacokinetics study of MLN0128 as a single agent and in combination with paclitaxel in adults with advanced nonhematologic malignancies. It enrolled 61 participants across sites in the United States.
Yes, Sapanisertib is also known as MLN0128. The completed Phase 1 trial NCT02412722 refers to the drug as MLN0128, evaluating it as a single agent and in combination with paclitaxel in adults with advanced nonhematologic malignancies. Both names refer to the same Takeda mTOR inhibitor.