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

Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02514603
• Other study ID #: 16018
• Secondary ID: I4D-JE-JTJK
• Status: Completed
• Phase: Phase 1
• First received: July 31, 2015
• Last updated: May 19, 2017
• Start date: October 2015
• Est. completion date: April 10, 2017

Study information

• Verified date: May 2017
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 10, 2017
• Est. primary completion date: April 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasm

Intervention

Drug:
• Prexasertib
Administered IV

Locations

Country	Name	City	State
Japan	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.	Chiba
Japan	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Prexasertib Dose-Limiting Toxicities (DLT)		Cycle 1 (14 day cycle)
Secondary	Pharmacokinetics (PK): Maximum Concentration (Cmax) of Prexasertib		Pre-dose up to 7 Days Post Treatment in Cycle 1/2 (Approximately 7 Days)
Secondary	Pharmacokinetics (PK): Area Under Curve (AUC) of Prexasertib		Pre-dose up to 7 Days Post Treatment in Cycle1/2 (Approximately 7 Days)
Secondary	Percentage of Participants with a Tumor Response		Baseline to Study Completion (Approximately 24 weeks)