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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02514603
Recruitment Status : Completed
First Posted : August 3, 2015
Last Update Posted : May 22, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Neoplasm Drug: Prexasertib Phase 1

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Study Type : Interventional  (Clinical Trial)
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 : October 2015
Actual Primary Completion Date : April 10, 2017
Actual Study Completion Date : April 10, 2017

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 Name: LY2606368




Primary Outcome Measures :
  1. Number of Participants with Prexasertib Dose-Limiting Toxicities (DLT) [ Time Frame: Cycle 1 (14 day cycle) ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02514603


Locations
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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, 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
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02514603    
Other Study ID Numbers: 16018
I4D-JE-JTJK ( Other Identifier: Eli Lilly and Company )
First Posted: August 3, 2015    Key Record Dates
Last Update Posted: May 22, 2017
Last Verified: May 2017
Keywords provided by Eli Lilly and Company:
Neoplasm metastasis
Checkpoint Kinase 1
CHK1
CHK1 inhibitor
Additional relevant MeSH terms:
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Neoplasms