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

NCT ID: NCT02514603

Last Updated: 2017-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-04-10

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.

Detailed Description

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Conditions

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Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Prexasertib

Intervention Type DRUG

Administered IV

Interventions

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Prexasertib

Administered IV

Intervention Type DRUG

Other Intervention Names

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LY2606368

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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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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

Site Status

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

Site Status

Countries

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Japan

Other Identifiers

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I4D-JE-JTJK

Identifier Type: OTHER

Identifier Source: secondary_id

16018

Identifier Type: -

Identifier Source: org_study_id

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