A Study of Prexasertib (LY2606368) in Japanese Participants With Advanced Cancers

Study Overview
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Brief Summary
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The primary purpose of this study is to assess the tolerability of prexasertib in Japanese participants with advanced solid cancers.

Official Title
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A Phase 1 Study of LY2606368 in Japanese Patients With Advanced Solid Tumors

Conditions
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Neoplasm

Intervention / Treatment
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* Drug: Prexasertib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant must be appropriate candidate for experimental therapy, as determined by investigator, after available standard therapies have failed Participant must have diagnosis of cancer that is advanced or metastatic Participant must have discontinued previous treatments for cancer and recovered from the acute effects of that therapy If participant is of reproductive potential, must agree to use medically approved contraceptive precautions during the study and for three months following the last dose of study drug If the participant is a female of childbearing potential, must have had a negative serum or urine pregnancy test within 7 days of the first dose of study drug and must not be breast feeding Exclusion Criteria: Participant must not have symptomatic central nervous system malignancy or metastasis Participant must not have current hematologic malignancy Participant must not have an active symptomatic fungal, bacterial or viral infection, including human immunodeficiency virus (HIV) or Hepatitis A, B, or C Participant must not have a serious cardiac condition

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prexasertib<br>Prexasertib intravenously (IV) on day 1 of a 14 day cycle. Treatment with prexasertib may continue until disease progression, unacceptable toxicity, or other discontinuation criteria are met. | Drug: Prexasertib<br>* Administered IV<br>* Other names: LY2606368;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Prexasertib Dose-Limiting Toxicities (DLT) |  | Cycle 1 (14 day cycle) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Prexasertib |  | Pre-dose up to 7 Days Post Treatment in Cycle 1/2 (Approximately 7 Days) | 
| Pharmacokinetics (PK): Area Under Curve (AUC) of Prexasertib |  | Pre-dose up to 7 Days Post Treatment in Cycle1/2 (Approximately 7 Days) | 
| Percentage of Participants with a Tumor Response |  | Baseline to Study Completion (Approximately 24 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neoplasm metastasis, Checkpoint Kinase 1, CHK1, CHK1 inhibitor