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Completed

NCT Number: NCT03898791

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

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.

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Key information

Conditions

Small Cell Lung Cancer Brain Diseases Bronchial Neoplasms Carcinoma, Bronchogenic Central Nervous System Diseases Epilepsy Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Grand Hopital de Charleroi-Site Notre-Dame, Charleroi, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LY3295668 Erbumine

Drug

oral capsules

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Phase 1b Study of LY3295668 Erbumine Monotherapy in Patients With Platinum-Sensitive, Extensive-Stage Small-Cell Lung Cancer

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Apr 2, 2019
Registry last updated
Aug 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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