Clinical trial NCT03898791: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Small Cell Lung Cancer
Keywords: aurora kinase A
kinase
aurora A
aurora kinase inhibitor
aurora kinase A inhibitor
kinase inhibitor
AURKA
AurA
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-04-02
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Participants with Dose Reductions
timeFrame: Baseline through Cycle 1 (28 Day Cycle)
measure: Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
timeFrame: Baseline through Measured Progressive Disease (Estimated up to 20 Months)
measure: Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3295668 Erbumine
timeFrame: Predose Cyce 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
measure: Duration of Response (DoR)
timeFrame: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated up to 20 Months)
Secondary outcomes:
measure: PK: Maximum Concentration (Cmax) of LY3295668 Erbumine
timeFrame: Predose Cyce 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
measure: Best Overall Response (BOR): Percentage of Participants with CR, PR, Stable Disease (SD), or Progressive Disease (PD)
timeFrame: Baseline to Date of Objective Disease Progression (Estimated up to 20 Months)
measure: Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, and SD
timeFrame: Baseline through Measured Progressive Disease (Estimated up to 20 Months)
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Denver
country: United States
facility: Rocky Mountain Cancer Center
state: Colorado
city: Tampa
country: United States
facility: H Lee Moffitt Cancer Center
state: Florida
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University Medical School
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Charlotte
country: United States
facility: Levine Cancer Institute- Carolinas Medical Center
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Greenville
country: United States
facility: Prisma Health Cancer Institute
state: South Carolina
city: Austin
country: United States
facility: Texas Oncology Cancer Center
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology Fort Worth
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: The Woodlands
country: United States
facility: US Oncology
state: Texas
city: Tyler
country: United States
facility: Tyler Cancer Center
state: Texas
city: Charleroi
country: Belgium
facility: Grand Hopital de Charleroi-Site Notre-Dame
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
city: Roeselare
country: Belgium
facility: AZ Delta
city: Bordeaux
country: France
facility: Institut Bergonie
city: Dijon Cedex
country: France
facility: Centre Georges Francois Leclerc
city: Lyon Cedex 08
country: France
facility: Centre de Lutte Contre le Cancer Leon Berard
city: Marseille
country: France
facility: APHM Hôpital de la Timone
city: Paris CEDEX 05
country: France
facility: Institut Curie
city: Saint Herblain Cedex
country: France
facility: Institut de Cancérologie de l'Ouest Centre René Gauducheau
city: Chuo-Ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
state: Korea
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Korea
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Malaga
country: Spain
facility: Hospital Clinico Universitario Virgen de la Victoria
state: Andalucia
city: L'Hospitalet de Llobregat
country: Spain
facility: Institut Catala d'Oncologia
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Valencia
country: Spain
facility: Hospital Universitario La Fe de Valencia
city: Ankara
country: Turkey
facility: Dr.Abdurrahman Yurtaslan Ankara Oncology Training & Res Hosp
city: Izmir
country: Turkey
facility: Ege University Faculty of Medicine
city: London
country: United Kingdom
facility: Guys/St. Thomas Hospital
state: Surrey
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
state: Surrey
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: