A Study of LY3295668 Erbumine in Participants With Extensive-stage Small-Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT03898791 |
Recruitment Status :
Completed
First Posted : April 2, 2019
Last Update Posted : August 5, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Small Cell Lung Cancer | Drug: LY3295668 Erbumine | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
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 : | July 16, 2019 |
Actual Primary Completion Date : | June 2, 2020 |
Actual Study Completion Date : | March 30, 2021 |
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 |
- Number of Participants with Dose Reductions [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: Predose Cyce 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles) ]PK: AUC of LY3295668 Erbumine
- 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
- 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
- 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
- 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
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898791
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 |
Responsible Party: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT03898791 |
Other Study ID Numbers: |
17248 J1O-MC-JZHB ( Other Identifier: Eli Lilly and Company ) 2018-003485-14 ( EudraCT Number ) |
First Posted: | April 2, 2019 Key Record Dates |
Last Update Posted: | August 5, 2021 |
Last Verified: | July 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | 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 Materials: |
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: | https://vivli.org/ |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
aurora kinase A kinase aurora A aurora kinase inhibitor |
aurora kinase A inhibitor kinase inhibitor AURKA AurA |
Lung Neoplasms Small Cell Lung Carcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |