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

Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03898791
• Other study ID #: 17248
• Secondary ID: J1O-MC-JZHB2018-
• Status: Completed
• Phase: Phase 1
• Start date: July 16, 2019
• Est. completion date: March 30, 2021

Study information

• Verified date: July 2021
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 30, 2021
• Est. primary completion date: June 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• LY3295668 Erbumine
oral capsules

Locations

Country	Name	City	State
Belgium	Grand Hopital de Charleroi-Site Notre-Dame	Charleroi
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg	Leuven
Belgium	AZ Delta	Roeselare
France	Institut Bergonie	Bordeaux
France	Centre Georges Francois Leclerc	Dijon Cedex
France	Centre de Lutte Contre le Cancer Leon Berard	Lyon Cedex 08
France	APHM Hôpital de la Timone	Marseille
France	Institut Curie	Paris CEDEX 05
France	Institut de Cancérologie de l'Ouest Centre René Gauducheau	Saint Herblain Cedex
Japan	National Cancer Center Hospital	Chuo-Ku	Tokyo
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul	Korea
Korea, Republic of	Severance Hospital Yonsei University Health System	Seoul	Korea
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Institut Catala d'Oncologia	L'Hospitalet de Llobregat	Barcelona
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Ramon y Cajal	Madrid
Spain	Hospital Clinico Universitario Virgen de la Victoria	Malaga	Andalucia
Spain	Hospital Universitario La Fe de Valencia	Valencia
Turkey	Dr.Abdurrahman Yurtaslan Ankara Oncology Training & Res Hosp	Ankara
Turkey	Ege University Faculty of Medicine	Izmir
United Kingdom	Guys/St. Thomas Hospital	London	Surrey
United Kingdom	Royal Marsden Hospital	Sutton	Surrey
United States	Texas Oncology Cancer Center	Austin	Texas
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Levine Cancer Institute- Carolinas Medical Center	Charlotte	North Carolina
United States	Rocky Mountain Cancer Center	Denver	Colorado
United States	Highlands Oncology Group	Fayetteville	Arkansas
United States	Texas Oncology Fort Worth	Fort Worth	Texas
United States	Prisma Health Cancer Institute	Greenville	South Carolina
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Washington University Medical School	Saint Louis	Missouri
United States	H Lee Moffitt Cancer Center	Tampa	Florida
United States	US Oncology	The Woodlands	Texas
United States	Tyler Cancer Center	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Belgium,  France,  Japan,  Korea, Republic of,  Spain,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Dose Reductions	Number of Participants with Dose Reductions	Baseline through Cycle 1 (28 Day Cycle)
Primary	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	Baseline through Measured Progressive Disease (Estimated up to 20 Months)
Primary	Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3295668 Erbumine	PK: AUC of LY3295668 Erbumine	Predose Cyce 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
Primary	Duration of Response (DoR)	DoR	Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated up to 20 Months)
Secondary	PK: Maximum Concentration (Cmax) of LY3295668 Erbumine	PK: Cmax of LY3295668 Erbumine	Predose Cyce 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
Secondary	Best Overall Response (BOR): Percentage of Participants with CR, PR, Stable Disease (SD), or Progressive Disease (PD)	BOR	Baseline to Date of Objective Disease Progression (Estimated up to 20 Months)
Secondary	Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, and SD	DCR	Baseline through Measured Progressive Disease (Estimated up to 20 Months)

External Links

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