CompletedPhase 2NCT02735980
Official study title

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

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedPrexasertib

The study team can explain what participation involves.

Who it may be forSmall cell lung cancer (SCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 17, 2020 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?41 U.S. locations

Locations may change over time.

Who runs it?Eli Lilly and Company

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Eli Lilly and Company
Interventions being studied
Drug: Prexasertib
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Have ED-SCLC and have received a prior platinum-based regimen
  • Participants in Cohort 1 and in the addendum 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Highlands Oncology GroupFayetteville, Arkansas
  • Yale University School of MedicineNew Haven, Connecticut
  • Georgetown University Medical CenterWashington D.C., District of Columbia
  • Florida Cancer SpecialistsFort Myers, Florida
  • Florida Cancer Specialists and Research InstituteSt. Petersburg, Florida
  • Massachusetts General HospitalDanvers, Massachusetts
  • Washington University Medical CenterSt Louis, Missouri
  • Dartmouth Hitchcock Medical CenterLebanon, New Hampshire
  • Chattanooga Oncology Hematology AssociatesChattanooga, Tennessee
  • Sarah Cannon Cancer CenterNashville, Tennessee
  • Tennessee Oncology PLLCNashville, Tennessee
  • Vanderbilt University Medical CenterNashville, Tennessee

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 17, 2020. Always confirm current availability with the study team.

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