Conditions: Metastatic Solid Tumors
Keywords: INK1117 PIK3CA KINASE TUMOR CANCER Locally advanced or metastatic solid tumors not eligible for standard of care therapy
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 125
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the maximum tolerated dose (MTD) and/or optimal biologic dose(OBD), safety and tolerability, dose-limiting toxicity (DLT) of TAK-117 when administered orally in subjects with advanced solid malignancies.

Detailed description:

Arms:
arm 1: TAK-117 administered once a day orally arm 2: TAK-117 administered orally intermittently, once every other day (Monday, Wednesday, and Friday) each week arm 3: TAK-117 administered orally intermittently, once a day for 3 consecutive days (Monday, Tuesday, and Wednesday) each week

Interventions: intervention 1: TAK-117
Intervention descriptions: intervention 1: oral administration of TAK-117, daily and intermittent schedules.

Protocol document: