Clinical Trials /

A Study of Prexasertib (LY2606368) in Participants With Extensive Stage Disease Small Cell Lung Cancer

NCT02735980

Description:

The purpose of this study is to evaluate the safety and efficacy of prexasertib when given to participants with extensive stage disease small cell lung cancer (ED-SCLC). The study will evaluate how the body processes the drug and how the drug affects the body. The study will also evaluate the association between tumor response and the participant's perceived quality of life.

Related Conditions:
  • Small Cell Lung Carcinoma
Recruiting Status:

Completed

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of Prexasertib (LY2606368) in Participants With Extensive Stage Disease Small Cell Lung Cancer
  • Official Title: A Phase 2 Study of LY2606368 in Patients With Extensive Stage Disease Small Cell Lung Cancer

Clinical Trial IDs

  • ORG STUDY ID: 16015
  • SECONDARY ID: I4D-MC-JTJH
  • SECONDARY ID: 2015-005069-21
  • NCT ID: NCT02735980

Conditions

  • Small Cell Lung Cancer

Interventions

DrugSynonymsArms
PrexasertibLY2606368Prexasertib (Platinum Sensitive Disease)

Purpose

The purpose of this study is to evaluate the safety and efficacy of prexasertib when given to participants with extensive stage disease small cell lung cancer (ED-SCLC). The study will evaluate how the body processes the drug and how the drug affects the body. The study will also evaluate the association between tumor response and the participant's perceived quality of life.

Trial Arms

NameTypeDescriptionInterventions
Prexasertib (Platinum Sensitive Disease)ExperimentalIntravenous (IV) prexasertib administered on day 1 of every 14 day cycle
  • Prexasertib
Prexasertib (Platinum Resistant Disease)ExperimentalIV prexasertib administered on day 1 of every 14 day cycle
  • Prexasertib

Eligibility Criteria

        Inclusion Criteria:

          -  Have ED-SCLC and have received a prior platinum-based regimen

          -  Participants in Cohort 1 must have had an objective response to prior platinum-based
             therapy with subsequent progression ≥90 days after the last dose of platinum

          -  Participants in Cohort 2 must have either not had an objective response to prior
             platinum based therapy or had progression <90 days after the last dose of platinum

          -  Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group scale

        Exclusion Criteria:

          -  Have received more than 2 prior therapies for ED-SCLC (including immunotherapy,
             targeted therapies, or chemotherapy)

          -  Have symptomatic central nervous system (CNS) malignancy or metastasis. Asymptomatic
             participants with treated CNS metastases are eligible for this study if they are not
             currently receiving corticosteroids to treat CNS metastases

          -  Have previously completed or withdrawn from this study or any other study
             investigating prexasertib or a checkpoint kinase I (CHK1) inhibitor or have shown
             hypersensitivity to any of the components of the prexasertib formulation

          -  Have a serious cardiac condition
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR)
Time Frame:Baseline through Disease Progression or Death (estimated at up to 28 months)
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Pharmacokinetics: Maximum Concentration of Prexasertib
Time Frame:Cycle 1 Predose through Cycle 7 End of Infusion Day 1 (14 day cycles)
Safety Issue:
Description:
Measure:Pharmacokinetics: Area Under the Concentration Curve of Prexasertib
Time Frame:Cycle 1 Predose through Cycle 7 End of Infusion Day 1 (14 day cycles)
Safety Issue:
Description:
Measure:Disease Control Rate: Percentage of Participants with a Best Overall Response of CR, PR, or Stable Disease (SD)
Time Frame:Baseline through Disease Progression or Death from Any Cause (estimated at up to 28 months)
Safety Issue:
Description:
Measure:Progression-Free Survival
Time Frame:Baseline to Disease Progression or Death (estimated at up to 28 months)
Safety Issue:
Description:
Measure:Duration of Response
Time Frame:Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (estimated at up to 28 months)
Safety Issue:
Description:
Measure:Overall Survival
Time Frame:Baseline to Date of Death from Any Cause (estimated at up to 28 months)
Safety Issue:
Description:
Measure:Change From Baseline in Lung Cancer Symptom Scale Score
Time Frame:Baseline, Short Term Follow-Up (estimated at up to 28 months)
Safety Issue:
Description:
Measure:Change from Baseline on the Average Symptom Burden Index (ASBI)
Time Frame:Baseline, Short Term Follow-Up (estimated at up to 28 months)
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Eli Lilly and Company

Trial Keywords

  • SCLC
  • LY2606368
  • CHK1

Last Updated

April 19, 2017