History of Changes for Study: NCT03898791

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

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Study Record Versions

Version	Submitted Date	Changes
1	April 1, 2019	None (earliest Version on record)
2	May 2, 2019	Contacts/Locations, Study Status and References
3	May 17, 2019	Contacts/Locations and Study Status
4	June 18, 2019	Study Status and Contacts/Locations
5	July 1, 2019	Contacts/Locations and Study Status
6	August 2, 2019	Recruitment Status, Study Status, Contacts/Locations and Oversight
7	August 16, 2019	Contacts/Locations and Study Status
8	August 19, 2019	Study Status
9	September 2, 2019	Study Status and Contacts/Locations
10	September 16, 2019	Contacts/Locations and Study Status
11	October 3, 2019	Study Status and Contacts/Locations
12	October 17, 2019	Contacts/Locations and Study Status
13	November 4, 2019	Study Status and Contacts/Locations
14	November 18, 2019	Contacts/Locations and Study Status
15	March 2, 2020	Study Status and Contacts/Locations
16	March 16, 2020	Contacts/Locations and Study Status
17	April 21, 2020	Contacts/Locations, Study Status and IPDSharing
18	May 4, 2020	Study Status
19	May 18, 2020	Contacts/Locations and Study Status
20	June 2, 2020	Contacts/Locations and Study Status
21	June 17, 2020	Recruitment Status, Study Status and Contacts/Locations
22	August 19, 2020	Study Status and Study Design
23	November 17, 2020	Study Status
24	March 2, 2021	Recruitment Status, Study Status and Study Design
25	July 30, 2021	Study Status and References

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	17248
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
Secondary IDs:	J1O-MC-JZHB [Eli Lilly and Company] 2018-003485-14 [EudraCT Number]

Study Status


Record Verification:	April 1, 2019
Overall Status:	Not yet recruiting
Study Start:	March 27, 2019
Primary Completion:	November 30, 2020 [Anticipated]
Study Completion:	November 30, 2020 [Anticipated]

First Submitted:	April 1, 2019
First Submitted that Met QC Criteria:	April 1, 2019
First Posted:	April 2, 2019 [Actual]

Last Update Submitted that Met QC Criteria:	April 1, 2019
Last Update Posted:	April 2, 2019 [Actual]

Sponsor/Collaborators


Sponsor:	Eli Lilly and Company
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:	No

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.
Detailed Description:

Conditions


Conditions:	Small Cell Lung Cancer
Keywords:	aurora kinase A kinase aurora A aurora kinase inhibitor aurora kinase A inhibitor kinase inhibitor AURKA AurA

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 1/Phase 2
Interventional Study Model:	Parallel Assignment
Number of Arms:	3
Masking:	None (Open Label)
Allocation:	Randomized
Enrollment:	64 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: LY3295668 Erbumine Cohort A LY3295668 erbumine administered orally.	Drug: LY3295668 Erbumine oral capsules
Experimental: LY3295668 Erbumine Cohort B LY3295668 erbumine administered orally.	Drug: LY3295668 Erbumine oral capsules
Experimental: LY3295668 Part JP LY3295668 erbumine administered orally.	Drug: LY3295668 Erbumine oral capsules

Outcome Measures


Primary Outcome Measures:
1.	Number of Participants with Dose Reductions [ Time Frame: Baseline through Cycle 1 (28 Day Cycle) ] Number of Participants with Dose Reductions
2.	Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR) [ Time Frame: Baseline through Measured Progressive Disease (Estimated up to 20 Months) ] ORR: Percentage of participants who achieve CR or PR
3.	Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3295668 Erbumine [ Time Frame: Predose Cyce 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles) ] PK: AUC of LY3295668 Erbumine
4.	Duration of Response (DoR) [ Time Frame: 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:
1.	PK: Maximum Concentration (Cmax) of LY3295668 Erbumine [ Time Frame: Predose Cyce 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles) ] PK: Cmax of LY3295668 Erbumine
2.	Best Overall Response (BOR): Percentage of Participants with CR, PR, Stable Disease (SD), or Progressive Disease (PD) [ Time Frame: Baseline to Date of Objective Disease Progression (Estimated up to 20 Months) ] BOR
3.	Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, and SD [ Time Frame: Baseline through Measured Progressive Disease (Estimated up to 20 Months) ] DCR

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
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.

Contacts/Locations


Central Contact Person:	There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or Telephone: 1-317-615-4559 Email: clinicaltrials.gov@lilly.com
Study Officials:	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) Study Director Eli Lilly and Company
Locations:	United States, Arkansas
	Highlands Oncology Group Fayetteville, Arkansas, United States, 72703 Contact:Principal Investigator: Eric S Schaefer
	United States, California
	City of Hope National Medical Center Duarte, California, United States, 91010-0269 Contact:Contact: 818-359-8111 Contact:Principal Investigator: Karen Reckamp
	United States, Colorado
	Rocky Mountain Cancer Center Denver, Colorado, United States, 80218 Contact:Contact: 303-388-4876 Contact:Principal Investigator: Robert Jotte
	United States, Florida
	H Lee Moffitt Cancer Center Tampa, Florida, United States, 33612 Contact:Principal Investigator: Alberto Chiappori
	United States, Massachusetts
	Massachusetts General Hospital Boston, Massachusetts, United States, 02114 Contact:Contact: 617-726-2515 Contact:Principal Investigator: Jacob Sands
	Dana Farber Cancer Institute Boston, Massachusetts, United States, 02215 Contact:Contact: 617-632-5869 Contact:Principal Investigator: Jacob Sands
	United States, Missouri
	Washington University Medical School Saint Louis, Missouri, United States, 63110 Contact:Contact: 314-362-1518 Contact:Principal Investigator: Siddhartha Devarakonda
	United States, New Hampshire
	Dartmouth Hitchcock Medical Center Lebanon, New Hampshire, United States, 03756-0001 Contact:Contact: 603-650-8162 Contact:Principal Investigator: Konstantin Dragnev
	United States, North Carolina
	Levine Cancer Institute- Carolinas Medical Center Charlotte, North Carolina, United States, 28204 Contact:Contact: 980-442-3105 Contact:Principal Investigator: Kathryn Mileham
	United States, Pennsylvania
	University of Pittsburgh Medical Center Pittsburgh, Pennsylvania, United States, 15232 Contact:Principal Investigator: Timothy F Burns
	United States, South Carolina
	Clinical Research Unit (ITOR) Greenville Hospital System Greenville, South Carolina, United States, 29605 Contact:Contact: 8644553600 Contact:Principal Investigator: William Jeffery Edenfield
	United States, Texas
	Texas Oncology Cancer Center Austin, Texas, United States, 78705 Contact:Contact: 512-421-4163 Contact:Principal Investigator: Jason M Melear
	Texas Oncology-Baylor Charles A. Sammons Cancer Center Fort Worth, Texas, United States, 76104 Contact:Contact: 817-413-1500 Contact:Principal Investigator: Stephen L Richey
	University of Texas MD Anderson Cancer Center Houston, Texas, United States, 77030 Contact:Contact: 713-792-6161 Contact:Principal Investigator: Lauren Byers
	US Oncology The Woodlands, Texas, United States, 77380 Contact:Contact: 281-863-1000 Contact:Principal Investigator: SMO US Oncology
	Tyler Cancer Center Tyler, Texas, United States, 75702 Contact:Contact: 903-579-9800 Contact:Principal Investigator: Donald A Richards
	Belgium
	Grand Hopital de Charleroi-Site Notre-Dame Charleroi, Belgium, 6000 Contact:Contact: 3271104700 Contact:Principal Investigator: Jean-Luc Canon
	Universitair Ziekenhuis Gent Gent, Belgium, 9000 Contact:Contact: 3293321530 Contact:Principal Investigator: Veerle Surmont
	Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg Leuven, Belgium, 3000 Contact:Contact: 3216346802 Contact:Principal Investigator: Kris Nackaerts
	AZ Delta Roeselare, Belgium, 8800 Contact:Contact: 3251237281 Contact:Principal Investigator: Ingel Demedts
	France
	Institut Bergonie Bordeaux, France, 33076 Contact:Contact: 33 5 47 30 60 88 Contact:Principal Investigator: Antoine Italiano
	Centre Georges Francois Leclerc Dijon Cedex, France, 21034 Contact:Contact: 33383737508 Contact:Principal Investigator: Nicolas ISAMBERT
	Centre Leon Berard Lyon Cedex 08, France, 69373 Contact:Principal Investigator: Philippe CASSIER
	APHM Hôpital de la Timone Marseille, France, 13385 Contact:Contact: 33491386578 Contact:Principal Investigator: Fabrice Barlesi
	Institut Curie Paris CEDEX 05, France, 75248 Contact:Contact: 330144324270 Contact:Principal Investigator: Catherine Daniel
	Centre René Gauducheau Saint Herblain Cedex, France, 44805 Contact:Contact: 33240679900 Contact:Principal Investigator: Judith Raimbourg
	Japan, Tokyo
	National Cancer Center Hospital Chuo-Ku, Tokyo, Japan, 104-0045 Contact:Contact: 81335422511 Contact:Principal Investigator: Noboru Yamamoto
	Korea, Republic of
	Asan Medical Center Seoul, Korea, Republic of, 05505 Contact:Contact: 82230103215 Contact:Principal Investigator: Sang-We Kim
	Korea, Republic of, Korea
	Severance Hospital Yonsei University Health System Seoul, Korea, Korea, Republic of, 03722 Contact:Contact: 82222288126 Contact:Principal Investigator: Byoung Chul Cho
	Samsung Medical Center Seoul, Korea, Korea, Republic of, 06351 Contact:Contact: 82234103459 Contact:Principal Investigator: Keunchil Park
	Spain
	Hospital Universitari Vall d'Hebron Barcelona, Spain, 08035 Contact:Principal Investigator: Alejandro Navarro
	Hospital Universitario Ramon y Cajal Madrid, Spain, 28034 Contact:Contact: 0034 91 336 8263 Contact:Principal Investigator: Maria Eugenia Olmedo
	Hospital Universitario 12 de Octubre Madrid, Spain, 28041 Contact:Contact: 34913908923 Contact:Principal Investigator: Luis Paz-Ares Rodríguez
	Hospital Universitario La Fe de Valencia Valencia, Spain, 46026 Contact:Contact: 34618734852 Contact:Principal Investigator: Óscar Juan Vidal
	Spain, Andalucia
	Hospital Clinico Universitario Virgen de la Victoria Malaga, Andalucia, Spain, 29010 Contact:Contact: 34951032274 Contact:Principal Investigator: José M. Trigo Pérez
	Spain, Barcelona
	Institut Catala d'Oncologia L'Hospitalet de Llobregat, Barcelona, Spain, 08907 Contact:Contact: 34932607744 Contact:Principal Investigator: Ernest Nadal Alforja
	Turkey
	Dr.Abdurrahman Yurtaslan Ankara Oncology Training & Res Hosp Ankara, Turkey, 06200 Contact:Contact: 905067521275 Contact:Principal Investigator: Umut Demirci
	Ege University Faculty of Medicine Izmir, Turkey, 35100 Contact:Contact: 905322202675 Contact:Principal Investigator: Tuncay Goksel
	United Kingdom
	Churchill Hospital Oxford, United Kingdom, OX3 7LJ Contact:Contact: 441865235991 Contact:Principal Investigator: Meenali Chitnis
	United Kingdom, Surrey
	Guys/St. Thomas Hospital London, Surrey, United Kingdom, SE1 9RT Contact:Contact: 442071887188 Contact:Principal Investigator: Eleni Karapanagiotou
	Royal Marsden Hospital Sutton, Surrey, United Kingdom, SM2 5PT Contact:Contact: +4420 8915 6142 Contact:Principal Investigator: Anna Minchom

IPDSharing


Plan to Share IPD:	Yes 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.
	Supporting Information: Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR)
	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.
	Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
	URL: http://www.clinicalstudydatarequest.com

References


Citations:
Links:
Available IPD/Information: