Conditions: Advanced Cancer
Keywords: Metastatic Cancer Solid Tumors
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 35
Healthy volunteers: no

Brief summary:
The objective of this phase 1 study is to evaluate the safety and tolerability of Notch Inhibitor in participants with advanced cancer. This study includes dose escalation and dose confirmation components.

Detailed description:

Arms:
arm 1: Dose escalation phase: 2 milligrams (mg), 4 mg, 8 mg, 15 mg, 30 mg, 45 mg and 60mg LY900009 administered orally 3 times per week (Monday, Wednesday, Friday) for 4 weeks of a 28-day cycle.

Dose confirmation phase: 30 mg LY900009 administered orally 3 times per week (Monday, Wednesday, Friday) for 4 weeks of a 28-day cycle.

Participants experiencing clinical benefit may continue treatment unless discontinuation criteria are met.

Interventions: intervention 1: LY900009 - Dose Escalation Phase (Part A) intervention 2: LY900009 - Dose Confirmation Phase (Part B)
Intervention descriptions: intervention 1: 2 milligrams (mg), 4 mg, 8 mg, 15 mg, 30 mg, 45 mg and 60mg LY900009 administered orally 3 times per week (Monday, Wednesday, Friday) for 4 weeks of a 28-day cycle.

Participants experiencing clinical benefit may continue treatment unless discontinuation criteria are met. intervention 2: 30 mg LY900009 orally 3 times per week (Monday, Wednesday, Friday) for 4 weeks of a 28-day cycle.

Participants experiencing clinical benefit may continue treatment unless discontinuation criteria are met.

Protocol document: