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

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ClinicalTrials.gov Identifier: NCT03898791
Recruitment Status : Not yet recruiting
First Posted : April 2, 2019
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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
Small Cell Lung Cancer Drug: LY3295668 Erbumine Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 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
Estimated Study Start Date : May 15, 2019
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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




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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

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


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 clinicaltrials.gov@lilly.com

  Show 40 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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

Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03898791     History of Changes
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: May 20, 2019
Last Verified: May 15, 2019
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: http://www.clinicalstudydatarequest.com

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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:
aurora kinase A
kinase
aurora A
aurora kinase inhibitor
aurora kinase A inhibitor
kinase inhibitor
AURKA
AurA

Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms