Sample size and statistical analyses
toxicity
DISEASE
Approximately, 25 patients were planned to be enrolled. The mTPI dosing schema was planned to maximize patients treated at or near the MTD. Any excessive toxicity, defined as the probability of the DLT level exceeding 25% being greater than 95%, would prevent the escalation to next or higher dose levels and would lead to early termination of the study.Statistical analyses were primarily descriptive and graphical in nature with no formal hypothesis testing. The safety population included all patients who received at least one dose of TAK-164. The response-evaluable population included all patients with measurable disease who received ≥ 1 dose of TAK-164 and had ≥ 1 post-baseline response assessment. The PK-evaluable population was defined as all patients with sufficient dosing and PK data to reliably estimate PK parameters.