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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02514603

Enrollment

Registered

2015-08-03

Start date

2015-10-31

Completion date

2017-04-10

Last updated

2017-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasm

Keywords

Neoplasm metastasis, Checkpoint Kinase 1, CHK1, CHK1 inhibitor

Brief summary

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

Interventions

DRUGPrexasertib

Administered IV

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Number of Participants with Prexasertib Dose-Limiting Toxicities (DLT)	Cycle 1 (14 day cycle)

Secondary

Measure	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)

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026