Description:
The main purpose of this study is to evaluate the safety of the study drug known as LY3200882
in participants with solid tumors.
Title
- Brief Title: A Study of LY3200882 in Participants With Solid Tumors
- Official Title: A Phase 1 Study of LY3200882 in Patients With Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
16185
- SECONDARY ID:
I8X-MC-JECA
- SECONDARY ID:
2016-001431-12
- NCT ID:
NCT02937272
Conditions
Interventions
Drug | Synonyms | Arms |
---|
LY3200882 | | Japanese Arm LY3200882 |
LY3300054 | | LY3200882 + LY3300054 |
Gemcitabine | | LY3200882 + Gemcitabine + nab-Paclitaxel |
nab-Paclitaxel | | LY3200882 + Gemcitabine + nab-Paclitaxel |
Cisplatin | | LY3200882 + Cisplatin + Radiation |
Purpose
The main purpose of this study is to evaluate the safety of the study drug known as LY3200882
in participants with solid tumors.
Trial Arms
Name | Type | Description | Interventions |
---|
LY3200882 Schedule 1 Escalation | Experimental | | |
LY3200882 Schedule 2 Escalation | Experimental | | |
LY3200882 Schedule 1 Expansion | Experimental | | |
LY3200882 Schedule 2 Expansion | Experimental | | |
LY3200882 + LY3300054 | Experimental | | |
LY3200882 + Gemcitabine + nab-Paclitaxel | Experimental | | - LY3200882
- Gemcitabine
- nab-Paclitaxel
|
LY3200882 + Cisplatin + Radiation | Experimental | | |
Japanese Arm LY3200882 | Experimental | | |
Eligibility Criteria
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) |
Time Frame: | Cycle 1 (28 days) |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Pharmacokinetics (PK): Area Under the Curve (AUC) (AUC[0-24]) at Steady State of LY3200882 |
Time Frame: | Cycle 1 Day 1 through Cycle 2 Day 14 (28 day cycles) |
Safety Issue: | |
Description: | |
Measure: | PK: AUC Zero to Infinity (AUC[0-∞]) at Steady State of LY3200882 |
Time Frame: | Cycle 1 Day 1 through Cycle 2 Day 14 (28 day cycles) |
Safety Issue: | |
Description: | |
Measure: | ORR: Percentage of Participants with CR or PR |
Time Frame: | Baseline through Disease Progression or Death (estimated at up to 12 months) |
Safety Issue: | |
Description: | |
Measure: | Overall Survival (OS) |
Time Frame: | Baseline to Date of Death from Any Cause (estimated at up to 12 months) |
Safety Issue: | |
Description: | |
Measure: | Duration of Response (DoR) |
Time Frame: | Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (estimated at up to 12 months) |
Safety Issue: | |
Description: | |
Measure: | Progression-Free Survival (PFS) |
Time Frame: | Baseline to Disease Progression or Death (estimated at up to 12 months) |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Eli Lilly and Company |
Trial Keywords
Last Updated
August 5, 2021