Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TAK-117 · 2 trials · 2 indications
MTD is highest dose level of TAK-117 at which no more than 1 out of 6 participants had a dose limiting toxicity (DLT) during first cycle. DLT was any 1 of following events occurring within first 21 days of Cycle 1 of TAK-117 administration, Grade 2: fasting hyperglycemia for \>14 days. Grade 3: nausea and/or vomiting/diarrhea for \>7 days; rash for \>7 days; thrombocytopenia with bleeding; fasting hyperglycemia for \>24 hours(hr). Grade \>=3:nonhematologic toxicity considered clinically significant by investigator. Grade 4:neutropenia (absolute neutrophil count \<=0.5\*10\^9per liter\[/L\]) for \>7 days in absence of growth factor support; neutropenia of any duration accompanied with fever \>=38.5 degree Celsius and/or systemic infection. Grade \>=4:hematologic toxicity. Inability to administer at least 75% of planned doses of TAK-117 within Cycle 1 due to its related toxicity;Any clinically significant occurrence that investigators and sponsor agreed would place participants at undue safety risk.
Severity of AEs was evaluated based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0 as follow: Grade 1 (mild); Grade 2 (moderate); Grade 3 (severe); Grade 4 (life-threatening); Grade 5 (fatal).
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | TAK-117 administered once a day orally |
| Arm B | EXPERIMENTAL | TAK-117 administered orally intermittently, once every other day (Monday, Wednesday, and Friday) each week |
| Arm C | EXPERIMENTAL | TAK-117 administered orally intermittently, once a day for 3 consecutive days (Monday, Tuesday, and Wednesday) each week |
| Part 1: TAK-117 9*100 mg + TAK-117 3*300 mg | EXPERIMENTAL | TAK-117900 milligram (mg), capsules, orally, once on Day 1, followed by 2 weeks of washout, followed by TAK-117 900 mg, tablets, orally, once on Day 15. |
| Part 1: TAK-117 3*300 mg + TAK-117 9*100 mg | EXPERIMENTAL | TAK-117 900 mg tablets, orally, once on Day 1, followed by 2 weeks of washout, followed by TAK-117 900 mg, capsules, orally, once on Day 15. |
| Part 2: TAK-117 Fasted + TAK-117 Fed | EXPERIMENTAL | TAK-117 at the dose determined in Part 1, tablets, in fasted condition, orally, once on Day 1, followed by 2 weeks of washout, followed by TAK-117 at the dose determined in Part 1, tablets, with a standard high-fat meal, orally, once on Day 15. |
| Part 2: TAK-117 Fed + TAK-117 Fasted | EXPERIMENTAL | TAK-117 at the dose determined in Part 1, tablets, with a standard high-fat meal, orally, once on Day 1, followed by 2 weeks of washout, followed by TAK-117 at the dose determined in Part 1, tablets, in fasted condition, orally, once on Day 15. |
| Part 3: TAK-117 + Lansoprazole | EXPERIMENTAL | TAK-117 at the dose determined in Part 1, tablets, orally, once on Day 1, followed by lansoprazole 30 mg, tablets or capsules, once daily from Day 10 to Day 15, followed by TAK-117 at the dose determined in Part 1, tablets, orally, once on Day 15. |
| Name | Type | Description |
|---|---|---|
| TAK-117 | DRUG | oral administration of TAK-117, daily and intermittent schedules. |
| Lansoprazole | DRUG | Lansoprazole capsules |
Inclusion Criteria: * Subjects have had their PIK3CA gene mutation status assessed prior to enrolling into the study * Subjects must have documented disease progression prior to enrolling into the study * locally advanced or metastatic solid tumors with the exception of primary brain tumor, and hav...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
TAK-117 is an investigational small molecule being studied for the treatment of metastatic solid tumors and advanced or metastatic neoplasms. It is in Phase 1 clinical development for these oncology indications. The drug is not approved and remains under investigation.
TAK-117 is a small molecule being developed for oncology. Its specific molecular target has not been disclosed in available information. The drug is being studied in patients with advanced or metastatic cancers to evaluate its safety and pharmacokinetics.
TAK-117 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 tolerability in patients with advanced cancers.
TAK-117 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing to assess its safety, tolerability, and pharmacokinetic profile in patients with advanced or metastatic solid tumors.
TAK-117 has been studied in two completed Phase 1 trials. NCT01449370 was a dose escalation study in 125 patients with metastatic solid tumors conducted in the United States, Spain, and the United Kingdom. NCT02625259 evaluated the drug's bioavailability and food effects in 54 healthy participants.
TAK-117 is also known as MLN1117. Clinical trial records refer to the drug by both names, with studies titled 'TAK-117 (MLN1117)' to indicate the same compound. This naming convention is used in the dose escalation study and the pharmacokinetic study.