A Study of LY3295668 Erbumine in Participants With Extensive-stage Small-Cell Lung Cancer

July 30, 2021 updated by: Eli Lilly and Company

Phase 1b Study of LY3295668 Erbumine Monotherapy in Patients With Platinum-Sensitive, Extensive-Stage Small-Cell Lung Cancer

The purpose of this study is to determine the recommended phase 2 dose of LY3295668 erbumine in participants with platinum-sensitive, extensive-stage small-cell lung cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

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

  • Belgium
      • Charleroi, Belgium, 6000
        • Grand Hopital de Charleroi-Site Notre-Dame
      • Gent, Belgium, 9000
        • Universitair Ziekenhuis Gent
      • Leuven, Belgium, 3000
        • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
      • Roeselare, Belgium, 8800
        • AZ Delta
  • France
      • Bordeaux, France, 33076
        • Institut Bergonie
      • Dijon Cedex, France, 21000
        • Centre Georges François Leclerc
      • Lyon Cedex 08, France, 69373
        • Centre de lutte contre le Cancer Leon Berard
      • Marseille, France, 13385
        • APHM Hopital de la Timone
      • Paris CEDEX 05, France, 75248
        • Institut Curie
      • Saint Herblain Cedex, France, 44805
        • Institut de cancérologie de l'Ouest Centre René GAUDUCHEAU
  • Japan
    • Tokyo
      • Chuo-Ku, Tokyo, Japan, 104-0045
        • National Cancer Center Hospital
  • Korea, Republic of
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
    • Korea
      • Seoul, Korea, Korea, Republic of, 06351
        • Samsung Medical Center
      • Seoul, Korea, Korea, Republic of, 03722
        • Severance Hospital Yonsei University Health System
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Valencia, Spain, 46026
        • Hospital Universitario La Fe de Valencia
    • Andalucia
      • Malaga, Andalucia, Spain, 29010
        • Hospital Clinico Universitario Virgen de la Victoria
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Institut Catala d'Oncologia
  • Turkey
      • Ankara, Turkey, 06200
        • Dr.Abdurrahman Yurtaslan Ankara Oncology Training & Res Hosp
      • Izmir, Turkey, 35100
        • Ege University Faculty of Medicine
  • United Kingdom
    • Surrey
      • London, Surrey, United Kingdom, SE1 9RT
        • Guys/St. Thomas Hospital
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Royal Marsden Hospital
  • United States
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Highlands Oncology Group
    • Colorado
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Center
    • Florida
      • Tampa, Florida, United States, 33612
        • H Lee Moffitt Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University Medical School
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756-0001
        • Dartmouth Hitchcock Medical Center
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Levine Cancer Institute- Carolinas Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh Medical Center
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Prisma Health Cancer Institute
    • Texas
      • Austin, Texas, United States, 78705
        • Texas Oncology Cancer Center
      • Fort Worth, Texas, United States, 76104
        • Texas Oncology Fort Worth
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center
      • The Woodlands, Texas, United States, 77380
        • US Oncology
      • Tyler, Texas, United States, 75702
        • Tyler 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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have histological or cytological evidence of a diagnosis of platinum sensitive small cell lung cancer that is extensive stage.
  • Have adequate organ function.
  • Have a performance status (PS) of ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale.
  • Have discontinued previous treatments for cancer.
  • Are able to swallow capsules.

Exclusion Criteria:

  • Currently enrolled in a clinical study.
  • Have a serious concomitant systemic disorder.
  • Have a symptomatic human immunodeficiency virus infection or symptomatic activated/reactivated hepatitis B or C.
  • Have a significant cardiac condition.
  • Have previously received an aurora kinase inhibitor.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LY3295668 Erbumine Cohort A
LY3295668 erbumine administered orally.
Drug: LY3295668 Erbumine
oral capsules
Experimental: LY3295668 Erbumine Cohort B
LY3295668 erbumine administered orally.
Drug: LY3295668 Erbumine
oral capsules
Experimental: LY3295668 Part JP
LY3295668 erbumine administered orally.
Drug: LY3295668 Erbumine
oral capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Dose Reductions
Time Frame: Baseline through Cycle 1 (28 Day Cycle)
Number of Participants with Dose Reductions
Baseline through Cycle 1 (28 Day Cycle)
Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
Time Frame: Baseline through Measured Progressive Disease (Estimated up to 20 Months)
ORR: Percentage of participants who achieve CR or PR
Baseline through Measured Progressive Disease (Estimated up to 20 Months)
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3295668 Erbumine
Time Frame: Predose Cyce 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
PK: AUC of LY3295668 Erbumine
Predose Cyce 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
Duration of Response (DoR)
Time Frame: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated up to 20 Months)
DoR
Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated up to 20 Months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PK: Maximum Concentration (Cmax) of LY3295668 Erbumine
Time Frame: Predose Cyce 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
PK: Cmax of LY3295668 Erbumine
Predose Cyce 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
Best Overall Response (BOR): Percentage of Participants with CR, PR, Stable Disease (SD), or Progressive Disease (PD)
Time Frame: Baseline to Date of Objective Disease Progression (Estimated up to 20 Months)
BOR
Baseline to Date of Objective Disease Progression (Estimated up to 20 Months)
Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, and SD
Time Frame: Baseline through Measured Progressive Disease (Estimated up to 20 Months)
DCR
Baseline through Measured Progressive Disease (Estimated up to 20 Months)

Collaborators and Investigators

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

Sponsor

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.

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)

July 16, 2019

Primary Completion (Actual)

June 2, 2020

Study Completion (Actual)

March 30, 2021

Study Registration Dates

First Submitted

April 1, 2019

First Submitted That Met QC Criteria

April 1, 2019

First Posted (Actual)

April 2, 2019

Study Record Updates

Last Update Posted (Actual)

August 5, 2021

Last Update Submitted That Met QC Criteria

July 30, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17248
  • J1O-MC-JZHB (Other Identifier: Eli Lilly and Company)
  • 2018-003485-14 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Small Cell Lung Cancer

Clinical Trials on LY3295668 Erbumine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe