A Study of LY3295668 Erbumine in Participants With Extensive-stage Small-Cell Lung Cancer
- Registration Number
- NCT03898791
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LY3295668 Part JP LY3295668 Erbumine LY3295668 erbumine administered orally. LY3295668 Erbumine Cohort A LY3295668 Erbumine LY3295668 erbumine administered orally. LY3295668 Erbumine Cohort B LY3295668 Erbumine LY3295668 erbumine administered orally.
- Primary Outcome Measures
Name Time Method Number of Participants with Dose Reductions Baseline through Cycle 1 (28 Day Cycle) Number of Participants with Dose Reductions
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3295668 Erbumine Predose Cyce 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles) PK: AUC of LY3295668 Erbumine
Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR) Baseline through Measured Progressive Disease (Estimated up to 20 Months) ORR: Percentage of participants who achieve CR or PR
Duration of Response (DoR) Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated up to 20 Months) DoR
- Secondary Outcome Measures
Name Time Method PK: Maximum Concentration (Cmax) of LY3295668 Erbumine Predose Cyce 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles) PK: Cmax of LY3295668 Erbumine
Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, and SD Baseline through Measured Progressive Disease (Estimated up to 20 Months) DCR
Best Overall Response (BOR): Percentage of Participants with CR, PR, Stable Disease (SD), or Progressive Disease (PD) Baseline to Date of Objective Disease Progression (Estimated up to 20 Months) BOR
Trial Locations
- Locations (40)
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Highlands Oncology Group
🇺🇸Fayetteville, Arkansas, United States
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
Centre Georges Francois Leclerc
🇫🇷Dijon Cedex, France
APHM Hôpital de la Timone
🇫🇷Marseille, France
National Cancer Center Hospital
🇯🇵Chuo-Ku, Tokyo, Japan
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Hospital Clinico Universitario Virgen de la Victoria
🇪🇸Malaga, Andalucia, Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Universitario Ramon y Cajal
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Dr.Abdurrahman Yurtaslan Ankara Oncology Training & Res Hosp
🇹🇷Ankara, Turkey
Ege University Faculty of Medicine
🇹🇷Izmir, Turkey
Guys/St. Thomas Hospital
🇬🇧London, Surrey, United Kingdom
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Institut Curie
🇫🇷Paris CEDEX 05, France
Severance Hospital Yonsei University Health System
🇰🇷Seoul, Korea, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Korea, Republic of
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
🇧🇪Leuven, Belgium
Institut de Cancérologie de l'Ouest Centre René Gauducheau
🇫🇷Saint Herblain Cedex, France
Institut Catala d'Oncologia
🇪🇸L'Hospitalet de Llobregat, Barcelona, Spain
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
AZ Delta
🇧🇪Roeselare, Belgium
Prisma Health Cancer Institute
🇺🇸Greenville, South Carolina, United States
Grand Hopital de Charleroi-Site Notre-Dame
🇧🇪Charleroi, Belgium
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Institut Bergonie
🇫🇷Bordeaux, France
Centre de Lutte Contre le Cancer Leon Berard
🇫🇷Lyon Cedex 08, France
Royal Marsden Hospital
🇬🇧Sutton, Surrey, United Kingdom
Washington University Medical School
🇺🇸Saint Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Levine Cancer Institute- Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
US Oncology
🇺🇸The Woodlands, Texas, United States
Texas Oncology Fort Worth
🇺🇸Fort Worth, Texas, United States
Tyler Cancer Center
🇺🇸Tyler, Texas, United States
Hospital Universitario La Fe de Valencia
🇪🇸Valencia, Spain
Rocky Mountain Cancer Center
🇺🇸Denver, Colorado, United States
University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
H Lee Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Texas Oncology Cancer Center
🇺🇸Austin, Texas, United States