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

NCT ID: NCT03898791

Last Updated: 2021-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-16

Study Completion Date

2021-03-30

Brief Summary

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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.

Detailed Description

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Conditions

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Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LY3295668 Erbumine Cohort A

LY3295668 erbumine administered orally.

Group Type EXPERIMENTAL

LY3295668 Erbumine

Intervention Type DRUG

oral capsules

LY3295668 Erbumine Cohort B

LY3295668 erbumine administered orally.

Group Type EXPERIMENTAL

LY3295668 Erbumine

Intervention Type DRUG

oral capsules

LY3295668 Part JP

LY3295668 erbumine administered orally.

Group Type EXPERIMENTAL

LY3295668 Erbumine

Intervention Type DRUG

oral capsules

Interventions

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LY3295668 Erbumine

oral capsules

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Highlands Oncology Group

Fayetteville, Arkansas, United States

Site Status

Rocky Mountain Cancer Center

Denver, Colorado, United States

Site Status

H Lee Moffitt Cancer Center

Tampa, Florida, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Washington University Medical School

St Louis, Missouri, United States

Site Status

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Levine Cancer Institute- Carolinas Medical Center

Charlotte, North Carolina, United States

Site Status

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Prisma Health Cancer Institute

Greenville, South Carolina, United States

Site Status

Texas Oncology Cancer Center

Austin, Texas, United States

Site Status

Texas Oncology Fort Worth

Fort Worth, Texas, United States

Site Status

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status

US Oncology

The Woodlands, Texas, United States

Site Status

Tyler Cancer Center

Tyler, Texas, United States

Site Status

Grand Hopital de Charleroi-Site Notre-Dame

Charleroi, , Belgium

Site Status

Universitair Ziekenhuis Gent

Ghent, , Belgium

Site Status

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

Leuven, , Belgium

Site Status

AZ Delta

Roeselare, , Belgium

Site Status

Institut Bergonie

Bordeaux, , France

Site Status

Centre Georges Francois Leclerc

Dijon, , France

Site Status

Centre de Lutte Contre le Cancer Leon Berard

Lyon, , France

Site Status

APHM Hôpital de la Timone

Marseille, , France

Site Status

Institut Curie

Paris, , France

Site Status

Institut de Cancérologie de l'Ouest Centre René Gauducheau

Saint-Herblain, , France

Site Status

National Cancer Center Hospital

Chuo-Ku, Tokyo, Japan

Site Status

Severance Hospital Yonsei University Health System

Seoul, Korea, South Korea

Site Status

Samsung Medical Center

Seoul, Korea, South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Hospital Clinico Universitario Virgen de la Victoria

Málaga, Andalusia, Spain

Site Status

Institut Catala d'Oncologia

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Site Status

Hospital Universitario Ramon y Cajal

Madrid, , Spain

Site Status

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status

Hospital Universitario La Fe de Valencia

Valencia, , Spain

Site Status

Dr.Abdurrahman Yurtaslan Ankara Oncology Training & Res Hosp

Ankara, , Turkey (Türkiye)

Site Status

Ege University Faculty of Medicine

Izmir, , Turkey (Türkiye)

Site Status

Guys/St. Thomas Hospital

London, Surrey, United Kingdom

Site Status

Royal Marsden Hospital

Sutton, Surrey, United Kingdom

Site Status

Countries

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United States Belgium France Japan South Korea Spain Turkey (Türkiye) United Kingdom

Related Links

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https://trials.lillytrialguide.com/en-US/trial/466NNvH4TeYW4gBJz8K9Xp

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

Other Identifiers

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J1O-MC-JZHB

Identifier Type: OTHER

Identifier Source: secondary_id

2018-003485-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

17248

Identifier Type: -

Identifier Source: org_study_id

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