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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT02514603
Collaborator
(none)
12
Enrollment
2
Locations
1
Arm
18.3
Duration (Months)
6
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1 Study of LY2606368 in Japanese Patients With Advanced Solid Tumors
Study Start Date :
Oct 1, 2015
Actual Primary Completion Date :
Apr 10, 2017
Actual Study Completion Date :
Apr 10, 2017

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants with Prexasertib Dose-Limiting Toxicities (DLT) [Cycle 1 (14 day cycle)]

    Secondary Outcome Measures

    1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Prexasertib [Pre-dose up to 7 Days Post Treatment in Cycle 1/2 (Approximately 7 Days)]

    2. Pharmacokinetics (PK): Area Under Curve (AUC) of Prexasertib [Pre-dose up to 7 Days Post Treatment in Cycle1/2 (Approximately 7 Days)]

    3. Percentage of Participants with a Tumor Response [Baseline to Study Completion (Approximately 24 weeks)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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. Chiba Japan 277 8577
    2 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

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: 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), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT02514603
    Other Study ID Numbers:
    • 16018
    • I4D-JE-JTJK
    First Posted:
    Aug 3, 2015
    Last Update Posted:
    May 22, 2017
    Last Verified:
    May 1, 2017
    Keywords provided by Eli Lilly and Company
    Neoplasm metastasis
    Checkpoint Kinase 1
    CHK1
    CHK1 inhibitor
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of May 22, 2017