Clinical Trials /

A Study of LY3200882 in Participants With Solid Tumors

NCT02937272

Description:

The main purpose of this study is to evaluate the safety of the study drug known as LY3200882 in participants with solid tumors.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

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

  • Solid Tumor

Interventions

DrugSynonymsArms
LY3200882LY3200882 Schedule 1 Escalation
LY3300054LY3200882 + LY3300054
GemcitabineLY3200882 + Gemcitabine + nab-Paclitaxel
nab-PaclitaxelLY3200882 + Gemcitabine + nab-Paclitaxel
CisplatinLY3200882 + 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

NameTypeDescriptionInterventions
LY3200882 Schedule 1 EscalationExperimental
  • LY3200882
LY3200882 Schedule 2 EscalationExperimental
  • LY3200882
LY3200882 Schedule 1 ExpansionExperimental
  • LY3200882
LY3200882 Schedule 2 ExpansionExperimental
  • LY3200882
LY3200882 + LY3300054Experimental
  • LY3200882
  • LY3300054
LY3200882 + Gemcitabine + nab-PaclitaxelExperimental
  • LY3200882
  • Gemcitabine
  • nab-Paclitaxel
LY3200882 + Cisplatin + RadiationExperimental
  • LY3200882
  • Cisplatin
Japanese Arm LY3200882Experimental
  • LY3200882

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:Recruiting
Lead Sponsor:Eli Lilly and Company

Trial Keywords

  • TGF Beta

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