Solid Tumor
Conditions
Keywords
TGF Beta
Brief summary
The main purpose of this study is to evaluate the safety of the study drug known as LY3200882 in participants with solid tumors.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
* The participant must have histological or cytological evidence of cancer. * Have adequate organ function. * Have Eastern Cooperative Oncology Group (ECOG) scale performance status of 0 or 1. * Are able to swallow capsules and tablets.
Exclusion criteria
* Have moderate or severe cardiovascular disease. * Have a serious concomitant systemic disorder. * Have acute leukemia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | Cycle 1 (28 days) |
| Part B: Overall Response Rate (ORR): Percentage of Participants with Complete Response (CR) or Partial Response (PR) | Baseline through Disease Progression or Death (estimated at up to 12 months) |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK): Area Under the Curve (AUC) (AUC[0-24]) at Steady State of LY3200882 | Cycle 1 Day 1 through Cycle 2 Day 14 (28 day cycles) |
| PK: AUC Zero to Infinity (AUC[0-∞]) at Steady State of LY3200882 | Cycle 1 Day 1 through Cycle 2 Day 14 (28 day cycles) |
| ORR: Percentage of Participants with CR or PR | Baseline through Disease Progression or Death (estimated at up to 12 months) |
| Overall Survival (OS) | Baseline to Date of Death from Any Cause (estimated at up to 12 months) |
| Duration of Response (DoR) | Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (estimated at up to 12 months) |
| Progression-Free Survival (PFS) | Baseline to Disease Progression or Death (estimated at up to 12 months) |
Countries
Australia, Canada, France, Germany, Italy, Japan, Spain, United States
Contacts
Eli Lilly and Company