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

May 19, 2017 updated by: Eli Lilly and Company

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chiba, Japan, 277 8577
        • 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, 104-0045
        • 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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Prexasertib
Administered IV
Other Names:
  • LY2606368

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

April 10, 2017

Study Completion (Actual)

April 10, 2017

Study Registration Dates

First Submitted

July 31, 2015

First Submitted That Met QC Criteria

July 31, 2015

First Posted (Estimate)

August 3, 2015

Study Record Updates

Last Update Posted (Actual)

May 22, 2017

Last Update Submitted That Met QC Criteria

May 19, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16018
  • I4D-JE-JTJK (Other Identifier: Eli Lilly and Company)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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