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TAK-931 PIC · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Part1: TAK-931 80 mg PIC + TAK-931 80 mg Tablet | EXPERIMENTAL | TAK-931 80 milligram (mg), PIC, orally, once on Day 1 Cycle 0 (16-day treatment cycle), followed by TAK-931 80 mg, tablet, orally, once on Day 3 Cycle 0, further followed by TAK-931 50 mg, PIC, orally, once daily from Day 5 to Day 16 Cycle 0. Participants will receive TAK-931 50 mg PIC, orally, once daily for up to 14 days in 21-day treatment cycles until progressive disease (PD), or unacceptable toxicity or any treatment discontinuation is determined. |
| Part1: TAK-931 80 mg Tablet + TAK-931 80 mg PIC | EXPERIMENTAL | TAK-931 80 mg, tablet, orally, once on Day 1 of Cycle 0 (16-day treatment cycle), followed by TAK-931 80 mg, PIC, orally, once on Day 3 Cycle 0, further followed by TAK-931 50 mg, PIC, orally, once daily from Day 5 to Day 16 Cycle 0. Participants will receive TAK-931 50 mg PIC, orally, once daily for up to 14 days in 21-day treatment cycles until PD, or unacceptable toxicity or any treatment discontinuation is determined. |
| Part 2: TAK-931 Fed + TAK-931 Fasted + Esomeprazole 40 mg | EXPERIMENTAL | TAK-931 tablet, orally, once under fed state on Day 1 Cycle 0 (22-day treatment cycle), followed by TAK-931 tablet, orally, once under fasted state on Day 3 Cycle 0, further followed by esomeprazole 40 mg, tablet, orally, once daily from Day 5 to Day 13 Cycle 0 and TAK-931 tablet, orally, once on Day 12, Day 14 to Day 22. Participants will receive TAK-931 tablets, orally, once daily for up to 14 days in 21-day treatment cycles until PD, unacceptable toxicity or any treatment discontinuation is determined. Dose of TAK-931 in Part 2 will be determined based on relative bioavailability data available from Part 1 of the study. |
| Part 2: TAK-931 Fasted + TAK-931 Fed + Esomeprazole 40 mg | EXPERIMENTAL | TAK-931 tablet, orally, once under fasted state on Day 1 Cycle 0 (22-day treatment cycle), followed by TAK-931 tablet, orally, once under fed state on Day 3 Cycle 0, further followed by esomeprazole 40 mg, tablet, orally, once daily from Day 5 to Day 13 Cycle 0 and TAK-931 tablet, orally, once on Day 12, Day 14 to Day 22. Participants will receive TAK-931 tablets, orally, once daily for up to 14 days in 21-day treatment cycles until PD, unacceptable toxicity or any treatment discontinuation is determined. Dose of TAK-931 in Part 2 will be determined based on relative bioavailability data available from Part 1 of the study. |
| Name | Type | Description |
|---|---|---|
| TAK-931 PIC | DRUG | TAK-931 PICs. |
| TAK-931 Tablet | DRUG | TAK-931 Tablets. |
| Esomeprazole | DRUG | Esomeprazole Tablets. |
Inclusion Criteria: 1. Adult participants with histologically or cytologically confirmed metastatic or locally advanced or metastatic solid tumors for whom there is no available standard treatment with proven survival benefit, this therapy is not indicated, or it is refused by the participant. Base...
TAK-931 PIC is an investigational small molecule being studied for the treatment of advanced solid tumors, including neoplasms. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
TAK-931 PIC is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics in patients with advanced solid tumors.
TAK-931 PIC is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies and is still being studied for safety and dosing in patients with advanced solid tumors.
TAK-931 PIC has one completed Phase 1 trial, NCT03708211, which assessed the relative bioavailability, effect of food, and gastric pH modification on the pharmacokinetics of the drug in participants with advanced solid tumors. The trial enrolled 20 participants in the Netherlands.
TAK-931 PIC is a formulation of TAK-931, a small molecule being developed by Takeda. The PIC designation likely refers to a specific formulation or salt form used in clinical studies, but both names refer to the same investigational drug.