Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02412722 | A Safety, Tolerability, and Pharmacokinetics Study of MLN0128 as a Single Agent and in Combination With Paclitaxel in Adults With Advanced Nonhematologic Malignancies | PHASE1 | COMPLETED | 61 | — | — | Mar 26, 2015 | May 31, 2018 | Feb 28, 2020 | 5 | United States |
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...