A Study of LY3295668 Erbumine in Participants With Extensive-stage Small-Cell Lung Cancer
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT03898791
Collaborator
(none)
48
40
3
20.5
1.2
0.1
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase 1b Study of LY3295668 Erbumine Monotherapy in Patients With Platinum-Sensitive, Extensive-Stage Small-Cell Lung Cancer
Actual Study Start Date
:
Jul 16, 2019
Actual Primary Completion Date
:
Jun 2, 2020
Actual Study Completion Date
:
Mar 30, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
- Number of Participants with Dose Reductions [Baseline through Cycle 1 (28 Day Cycle)]
Number of Participants with Dose Reductions
- 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
- 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
- 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
- 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
- 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
- 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
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Highlands Oncology Group | Fayetteville | Arkansas | United States | 72703 |
| 2 | Rocky Mountain Cancer Center | Denver | Colorado | United States | 80218 |
| 3 | H Lee Moffitt Cancer Center | Tampa | Florida | United States | 33612 |
| 4 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 5 | Dana Farber Cancer Institute | Boston | Massachusetts | United States | 02215 |
| 6 | Washington University Medical School | Saint Louis | Missouri | United States | 63110 |
| 7 | Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756-0001 |
| 8 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
| 9 | Levine Cancer Institute- Carolinas Medical Center | Charlotte | North Carolina | United States | 28204 |
| 10 | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | United States | 15232 |
| 11 | Prisma Health Cancer Institute | Greenville | South Carolina | United States | 29605 |
| 12 | Texas Oncology Cancer Center | Austin | Texas | United States | 78705 |
| 13 | Texas Oncology Fort Worth | Fort Worth | Texas | United States | 76104 |
| 14 | University of Texas MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
| 15 | US Oncology | The Woodlands | Texas | United States | 77380 |
| 16 | Tyler Cancer Center | Tyler | Texas | United States | 75702 |
| 17 | Grand Hopital de Charleroi-Site Notre-Dame | Charleroi | Belgium | 6000 | |
| 18 | Universitair Ziekenhuis Gent | Gent | Belgium | 9000 | |
| 19 | Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg | Leuven | Belgium | 3000 | |
| 20 | AZ Delta | Roeselare | Belgium | 8800 | |
| 21 | Institut Bergonie | Bordeaux | France | 33076 | |
| 22 | Centre Georges Francois Leclerc | Dijon Cedex | France | 21000 | |
| 23 | Centre de Lutte Contre le Cancer Leon Berard | Lyon Cedex 08 | France | 69373 | |
| 24 | APHM Hôpital de la Timone | Marseille | France | 13385 | |
| 25 | Institut Curie | Paris CEDEX 05 | France | 75248 | |
| 26 | Institut de Cancérologie de l'Ouest Centre René Gauducheau | Saint Herblain Cedex | France | 44805 | |
| 27 | National Cancer Center Hospital | Chuo-Ku | Tokyo | Japan | 104-0045 |
| 28 | Severance Hospital Yonsei University Health System | Seoul | Korea | Korea, Republic of | 03722 |
| 29 | Samsung Medical Center | Seoul | Korea | Korea, Republic of | 06351 |
| 30 | Asan Medical Center | Seoul | Korea, Republic of | 05505 | |
| 31 | Hospital Clinico Universitario Virgen de la Victoria | Malaga | Andalucia | Spain | 29010 |
| 32 | Institut Catala d'Oncologia | L'Hospitalet de Llobregat | Barcelona | Spain | 08907 |
| 33 | Hospital Universitari Vall d'Hebron | Barcelona | Spain | 08035 | |
| 34 | Hospital Universitario Ramon y Cajal | Madrid | Spain | 28034 | |
| 35 | Hospital Universitario 12 de Octubre | Madrid | Spain | 28041 | |
| 36 | Hospital Universitario La Fe de Valencia | Valencia | Spain | 46026 | |
| 37 | Dr.Abdurrahman Yurtaslan Ankara Oncology Training & Res Hosp | Ankara | Turkey | 06200 | |
| 38 | Ege University Faculty of Medicine | Izmir | Turkey | 35100 | |
| 39 | Guys/St. Thomas Hospital | London | Surrey | United Kingdom | SE1 9RT |
| 40 | Royal Marsden Hospital | Sutton | Surrey | United Kingdom | SM2 5PT |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: 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), Eli Lilly and Company
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT03898791
Other Study ID Numbers:
- 17248
- J1O-MC-JZHB
- 2018-003485-14
First Posted:
Apr 2, 2019
Last Update Posted:
Aug 5, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Eli Lilly and Company
Additional relevant MeSH terms: