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

Primary Purpose

Small Cell Lung Cancer

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
LY3295668 Erbumine
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring aurora kinase A, kinase, aurora A, aurora kinase inhibitor, aurora kinase A inhibitor, kinase inhibitor, AURKA, AurA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Highlands Oncology Group
  • Rocky Mountain Cancer Center
  • H Lee Moffitt Cancer Center
  • Massachusetts General Hospital
  • Dana Farber Cancer Institute
  • Washington University Medical School
  • Dartmouth Hitchcock Medical Center
  • Memorial Sloan Kettering Cancer Center
  • Levine Cancer Institute- Carolinas Medical Center
  • University of Pittsburgh Medical Center
  • Prisma Health Cancer Institute
  • Texas Oncology Cancer Center
  • Texas Oncology Fort Worth
  • University of Texas MD Anderson Cancer Center
  • US Oncology
  • Tyler Cancer Center
  • Grand Hopital de Charleroi-Site Notre-Dame
  • Universitair Ziekenhuis Gent
  • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
  • AZ Delta
  • Institut Bergonie
  • Centre Georges Francois Leclerc
  • Centre de Lutte Contre le Cancer Leon Berard
  • APHM Hôpital de la Timone
  • Institut Curie
  • Institut de Cancérologie de l'Ouest Centre René Gauducheau
  • National Cancer Center Hospital
  • Severance Hospital Yonsei University Health System
  • Samsung Medical Center
  • Asan Medical Center
  • Hospital Clinico Universitario Virgen de la Victoria
  • Institut Catala d'Oncologia
  • Hospital Universitari Vall d'Hebron
  • Hospital Universitario Ramon y Cajal
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario La Fe de Valencia
  • Dr.Abdurrahman Yurtaslan Ankara Oncology Training & Res Hosp
  • Ege University Faculty of Medicine
  • Guys/St. Thomas Hospital
  • Royal Marsden Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

LY3295668 Erbumine Cohort A

LY3295668 Erbumine Cohort B

LY3295668 Part JP

Arm Description

LY3295668 erbumine administered orally.

LY3295668 erbumine administered orally.

LY3295668 erbumine administered orally.

Outcomes

Primary Outcome Measures

Number of Participants with Dose Reductions
Number of Participants with Dose Reductions
Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
ORR: Percentage of participants who achieve CR or PR
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3295668 Erbumine
PK: AUC of LY3295668 Erbumine
Duration of Response (DoR)
DoR

Secondary Outcome Measures

PK: Maximum Concentration (Cmax) of LY3295668 Erbumine
PK: Cmax of LY3295668 Erbumine
Best Overall Response (BOR): Percentage of Participants with CR, PR, Stable Disease (SD), or Progressive Disease (PD)
BOR
Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, and SD
DCR

Full Information

First Posted
April 1, 2019
Last Updated
July 30, 2021
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT03898791
Brief Title
A Study of LY3295668 Erbumine in Participants With Extensive-stage Small-Cell Lung Cancer
Official Title
Phase 1b Study of LY3295668 Erbumine Monotherapy in Patients With Platinum-Sensitive, Extensive-Stage Small-Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
July 16, 2019 (Actual)
Primary Completion Date
June 2, 2020 (Actual)
Study Completion Date
March 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer
Keywords
aurora kinase A, kinase, aurora A, aurora kinase inhibitor, aurora kinase A inhibitor, kinase inhibitor, AURKA, AurA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LY3295668 Erbumine Cohort A
Arm Type
Experimental
Arm Description
LY3295668 erbumine administered orally.
Arm Title
LY3295668 Erbumine Cohort B
Arm Type
Experimental
Arm Description
LY3295668 erbumine administered orally.
Arm Title
LY3295668 Part JP
Arm Type
Experimental
Arm Description
LY3295668 erbumine administered orally.
Intervention Type
Drug
Intervention Name(s)
LY3295668 Erbumine
Intervention Description
oral capsules
Primary Outcome Measure Information:
Title
Number of Participants with Dose Reductions
Description
Number of Participants with Dose Reductions
Time Frame
Baseline through Cycle 1 (28 Day Cycle)
Title
Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
Description
ORR: Percentage of participants who achieve CR or PR
Time Frame
Baseline through Measured Progressive Disease (Estimated up to 20 Months)
Title
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3295668 Erbumine
Description
PK: AUC of LY3295668 Erbumine
Time Frame
Predose Cyce 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
Title
Duration of Response (DoR)
Description
DoR
Time Frame
Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated up to 20 Months)
Secondary Outcome Measure Information:
Title
PK: Maximum Concentration (Cmax) of LY3295668 Erbumine
Description
PK: Cmax of LY3295668 Erbumine
Time Frame
Predose Cyce 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
Title
Best Overall Response (BOR): Percentage of Participants with CR, PR, Stable Disease (SD), or Progressive Disease (PD)
Description
BOR
Time Frame
Baseline to Date of Objective Disease Progression (Estimated up to 20 Months)
Title
Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, and SD
Description
DCR
Time Frame
Baseline through Measured Progressive Disease (Estimated up to 20 Months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Highlands Oncology Group
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
Rocky Mountain Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
H Lee Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Washington University Medical School
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0001
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Levine Cancer Institute- Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Prisma Health Cancer Institute
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Texas Oncology Cancer Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Texas Oncology Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
US Oncology
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Facility Name
Tyler Cancer Center
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Grand Hopital de Charleroi-Site Notre-Dame
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
AZ Delta
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Centre Georges Francois Leclerc
City
Dijon Cedex
ZIP/Postal Code
21000
Country
France
Facility Name
Centre de Lutte Contre le Cancer Leon Berard
City
Lyon Cedex 08
ZIP/Postal Code
69373
Country
France
Facility Name
APHM Hôpital de la Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Institut Curie
City
Paris CEDEX 05
ZIP/Postal Code
75248
Country
France
Facility Name
Institut de Cancérologie de l'Ouest Centre René Gauducheau
City
Saint Herblain Cedex
ZIP/Postal Code
44805
Country
France
Facility Name
National Cancer Center Hospital
City
Chuo-Ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Severance Hospital Yonsei University Health System
City
Seoul
State/Province
Korea
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Korea
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Hospital Clinico Universitario Virgen de la Victoria
City
Malaga
State/Province
Andalucia
ZIP/Postal Code
29010
Country
Spain
Facility Name
Institut Catala d'Oncologia
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Dr.Abdurrahman Yurtaslan Ankara Oncology Training & Res Hosp
City
Ankara
ZIP/Postal Code
06200
Country
Turkey
Facility Name
Ege University Faculty of Medicine
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Guys/St. Thomas Hospital
City
London
State/Province
Surrey
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/466NNvH4TeYW4gBJz8K9Xp
Description
A Study of LY3295668 Erbumine in Participants With Extensive-stage Small-Cell Lung Cancer

Learn more about this trial

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

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