A Study of LY3405105 in Participants With Advanced Cancer

Arms (1)

1. type

   EXPERIMENTAL

   label

   LY3405105

   description

   This study was designed to be conducted in two phases: Phase 1a: This is a dose-escalation phase with a starting dose of LY3405105 1 milligram (mg) once daily (Part A1) or 2 mg three times per week (Part A2) on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason. Each dose-level will be determined and will have participants enrolled to it based on dose-limiting toxicity rate observed at previous dose-level. Intermediate, alternate, or higher dose levels will be explored if deemed necessary. Phase 1b: This is a dose-expansion phase designed to explore the anti-tumor activity of recommended LY3405105 dose and dosing schedule determined in phase 1a, in participants with multiple tumor types. \[Phase 1b was planned but not initiated based on the sponsor's decision and limited efficacy observed in phase 1a\]

   interventionNames

   1. Drug: LY3405105

Primary outcomes (2)

1. measure

   Phase 1a: Number of Participants With Dose Limiting Toxicities (DLTs)

   timeFrame

   Cycle 1 (Up To 28 Days)

   description

   A DLT is a clinically significant adverse event that is possibly related to the study drug and fulfils any one of the following criteria using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) v4.0: 1\) Nonhematologic Grade ≥3 toxicity, except nausea, constipation, diarrhoea, vomiting or electrolyte disturbance lasting for \<72 hours and can be controlled with treatment, fatigue/anorexia lasting for \<5 days, transient grade 3 elevations of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST), without evidence of other hepatic injury; 2) Total bilirubin \>2×upper limit of normal (ULN) with ALT/AST \>3×ULN in the absence of cholestasis (alkaline phosphatase \<2×ULN); 3) Grade 4 neutropenia \>5 days duration, Any febrile neutropenia, Grade 4 thrombocytopenia of any duration, Grade 3 thrombocytopenia with clinically significant bleeding, Grade 3/4 anemia or any other significant toxicity deemed to be dose limiting by investigators.