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
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Charleroi, Belgium, 6000
- Grand Hopital de Charleroi-Site Notre-Dame
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Gent, Belgium, 9000
- Universitair Ziekenhuis Gent
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Leuven, Belgium, 3000
- Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
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Roeselare, Belgium, 8800
- AZ Delta
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Bordeaux, France, 33076
- Institut Bergonie
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Dijon Cedex, France, 21000
- Centre Georges François Leclerc
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Lyon Cedex 08, France, 69373
- Centre de lutte contre le cancer Léon Bérard
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Marseille, France, 13385
- APHM Hopital de la Timone
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Paris CEDEX 05, France, 75248
- Institut Curie
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Saint Herblain Cedex, France, 44805
- Institut de cancérologie de l'Ouest Centre René GAUDUCHEAU
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Tokyo
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Chuo-Ku, Tokyo, Japan, 104-0045
- National Cancer Center Hospital
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Seoul, Korea, Republic of, 05505
- Asan Medical Center
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Korea
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Seoul, Korea, Korea, Republic of, 06351
- Samsung Medical Center
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Seoul, Korea, Korea, Republic of, 03722
- Severance Hospital Yonsei University Health System
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Barcelona, Spain, 08035
- Hospital Universitari Vall d'Hebron
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Madrid, Spain, 28034
- Hospital Universitario Ramon Y Cajal
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Madrid, Spain, 28041
- Hospital Universitario 12 De Octubre
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Valencia, Spain, 46026
- Hospital Universitario La Fe de Valencia
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Andalucia
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Malaga, Andalucia, Spain, 29010
- Hospital Clinico Universitario Virgen de la Victoria
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Barcelona
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L'Hospitalet de Llobregat, Barcelona, Spain, 08907
- Institut Catala d'Oncologia
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Ankara, Turkey, 06200
- Dr.Abdurrahman Yurtaslan Ankara Oncology Training & Res Hosp
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Izmir, Turkey, 35100
- Ege University Faculty of Medicine
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Surrey
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London, Surrey, United Kingdom, SE1 9RT
- Guys/St. Thomas Hospital
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Sutton, Surrey, United Kingdom, SM2 5PT
- Royal Marsden Hospital
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Arkansas
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Fayetteville, Arkansas, United States, 72703
- Highlands Oncology Group
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Colorado
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Denver, Colorado, United States, 80218
- Rocky Mountain Cancer Center
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Florida
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Tampa, Florida, United States, 33612
- H Lee Moffitt Cancer Center
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, United States, 02215
- Dana Farber Cancer Institute
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University Medical School
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New Hampshire
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Lebanon, New Hampshire, United States, 03756-0001
- Dartmouth Hitchcock Medical Center
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New York
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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North Carolina
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Charlotte, North Carolina, United States, 28204
- Levine Cancer Institute- Carolinas Medical Center
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15232
- University of Pittsburgh Medical Center
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South Carolina
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Greenville, South Carolina, United States, 29605
- Prisma Health Cancer Institute
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Texas
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Austin, Texas, United States, 78705
- Texas Oncology Cancer Center
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Fort Worth, Texas, United States, 76104
- Texas Oncology Fort Worth
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Houston, Texas, United States, 77030
- University of Texas MD Anderson Cancer Center
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The Woodlands, Texas, United States, 77380
- US Oncology
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Tyler, Texas, United States, 75702
- Tyler Cancer Center
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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 |
|---|---|
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Experimental: LY3295668 Erbumine Cohort A
LY3295668 erbumine administered orally.
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oral capsules
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Experimental: LY3295668 Erbumine Cohort B
LY3295668 erbumine administered orally.
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oral capsules
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Experimental: LY3295668 Part JP
LY3295668 erbumine administered orally.
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oral capsules
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of Participants with Dose Reductions
Time Frame: Baseline through Cycle 1 (28 Day Cycle)
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Number of Participants with Dose Reductions
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Baseline through Cycle 1 (28 Day Cycle)
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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)
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ORR: Percentage of participants who achieve CR or PR
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Baseline through Measured Progressive Disease (Estimated up to 20 Months)
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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)
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PK: AUC of LY3295668 Erbumine
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Predose Cyce 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
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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)
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DoR
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Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated up to 20 Months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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PK: Maximum Concentration (Cmax) of LY3295668 Erbumine
Time Frame: Predose Cyce 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
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PK: Cmax of LY3295668 Erbumine
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Predose Cyce 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
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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)
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BOR
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Baseline to Date of Objective Disease Progression (Estimated up to 20 Months)
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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)
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DCR
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Baseline through Measured Progressive Disease (Estimated up to 20 Months)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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.