A Study of LY3200882 in Participants With Solid Tumors

March 14, 2024 updated by: Eli Lilly and Company

A Phase 1 Study of LY3200882 in Patients With Solid Tumors

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

223

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Newcastle, New South Wales, Australia, 2298
        • Calvary Mater Newcastle
      • Sydney, New South Wales, Australia, 2010
        • St Vincent's Hospital
    • Queensland
      • Greenslopes, Queensland, Australia, 4120
        • Greenslopes Private Hospital
  • Canada
    • Kowloon
      • Lai Chi Kok, Kowloon, Canada, M5G 2M9
        • Princess Margaret Hospital
  • France
      • Lille, France, 59037
        • CHRU de Lille - Hôpital Roger Salengro
      • Villejuif Cedex, France, 94805
        • Gustave Roussy
    • Cedex 10
      • Paris, Cedex 10, France, 75475
        • Hôpital Saint-Louis
  • Germany
      • Berlin, Germany, 12203
        • Charité Universitätsmedizin Berlin
    • Bayern
      • Würzburg, Bayern, Germany, 97080
        • Universitätsklinikum Würzburg
  • Italy
      • Verona, Italy, 37134
        • Ospedale Policlinico Giambattista Rossi, Borgo Roma
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Istituto Clinico Humanitas
  • Japan
    • Tokyo
      • Chuo-Ku, Tokyo, Japan, 104-0045
        • National Cancer Center Hospital
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario de Valencia
  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
    • New York
      • New York, New York, United States, 10021
        • Weill Cornell Medical College
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LY3200882 Schedule 1 Escalation
Drug: LY3200882
Administered orally
Experimental: LY3200882 Schedule 2 Escalation
Drug: LY3200882
Administered orally
Experimental: LY3200882 Schedule 1 Expansion
Drug: LY3200882
Administered orally
Experimental: LY3200882 Schedule 2 Expansion
Drug: LY3200882
Administered orally
Experimental: LY3200882 + LY3300054
Drug: LY3200882
Administered orally
Drug: LY3300054
Administered intravenously
Experimental: LY3200882 + Gemcitabine + nab-Paclitaxel
Drug: nab-Paclitaxel
Administered intravenously
Drug: Gemcitabine
Administered intravenously
Drug: LY3200882
Administered orally
Experimental: LY3200882 + Cisplatin + Radiation
Drug: Cisplatin
Administered intravenously
Drug: LY3200882
Administered orally
Radiation: Intensity Modulated Radiotherapy
Experimental: Japanese Arm LY3200882
Drug: LY3200882
Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
Time Frame: Cycle 1 (28 days)
Cycle 1 (28 days)
Part B: Overall Response Rate (ORR): Percentage of Participants with Complete Response (CR) or Partial Response (PR)
Time Frame: Baseline through Disease Progression or Death (estimated at up to 12 months)
Baseline through Disease Progression or Death (estimated at up to 12 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
Cycle 1 Day 1 through Cycle 2 Day 14 (28 day cycles)
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)
Cycle 1 Day 1 through Cycle 2 Day 14 (28 day cycles)
ORR: Percentage of Participants with CR or PR
Time Frame: Baseline through Disease Progression or Death (estimated at up to 12 months)
Baseline through Disease Progression or Death (estimated at up to 12 months)
Overall Survival (OS)
Time Frame: Baseline to Date of Death from Any Cause (estimated at up to 12 months)
Baseline to Date of Death from Any Cause (estimated at up to 12 months)
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)
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)
Time Frame: Baseline to Disease Progression or Death (estimated at up to 12 months)
Baseline to Disease Progression or Death (estimated at up to 12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2016

Primary Completion (Actual)

February 27, 2020

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

October 17, 2016

First Submitted That Met QC Criteria

October 17, 2016

First Posted (Estimated)

October 18, 2016

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16185
  • I8X-MC-JECA (Other Identifier: Eli Lilly and Company)
  • 2016-001431-12 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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