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

Phase 1

Completed

• Conditions: Neoplasm
• Interventions: Drug: Prexasertib

• Registration Number: NCT02514603
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-31
• Study First Submitted QC: 2015-07-31
• Study First Posted: 2015-08-03
• Study Start: 2015-10
• Primary Completion: 2017-04-10
• Study Completion: 2017-04-10
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-19
• Last Update Posted: 2017-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prexasertib	Prexasertib	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇯🇵 Tokyo, Japan