| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01449370 | Dose Escalation Study of TAK-117 (MLN1117) in Subjects With Advanced Cancer | PHASE1 | COMPLETED | 125 | — | — | Oct 1, 2011 | Jan 1, 2016 | Mar 9, 2017 | 5 | United States, Spain +1 |
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 |
| Name | Type | Description |
|---|---|---|
| TAK-117 | DRUG | oral administration of TAK-117, daily and intermittent schedules. |
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, V503, GARDASIL |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| AstraZeneca PLC | AZN | 1 | — | Trastuzumab deruxtecan |