NCT02514603

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 3, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2017

Completed
Last Updated

May 22, 2017

Status Verified

May 1, 2017

Enrollment Period

1.5 years

First QC Date

July 31, 2015

Last Update Submit

May 19, 2017

Conditions

Neoplasm

Keywords

Neoplasm metastasisCheckpoint Kinase 1CHK1CHK1 inhibitor

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Prexasertib Dose-Limiting Toxicities (DLT)

    Cycle 1 (14 day cycle)

Secondary Outcomes (3)

  • Pharmacokinetics (PK): Maximum Concentration (Cmax) of Prexasertib

    Pre-dose up to 7 Days Post Treatment in Cycle 1/2 (Approximately 7 Days)

  • Pharmacokinetics (PK): Area Under Curve (AUC) of Prexasertib

    Pre-dose up to 7 Days Post Treatment in Cycle1/2 (Approximately 7 Days)

  • Percentage of Participants with a Tumor Response

    Baseline to Study Completion (Approximately 24 weeks)

Study Arms (1)

Prexasertib

EXPERIMENTAL

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

Interventions

PrexasertibDRUG

Administered IV

Also known as: LY2606368
Prexasertib

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (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.

Chiba, 277 8577, Japan

Location

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, 104-0045, Japan

Location

MeSH Terms

Conditions

NeoplasmsNeoplasm Metastasis

Interventions

prexasertib

Condition Hierarchy (Ancestors)

Neoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 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 DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2015

First Posted

August 3, 2015

Study Start

October 1, 2015

Primary Completion

April 10, 2017

Study Completion

April 10, 2017

Last Updated

May 22, 2017

Record last verified: 2017-05

Locations

JP(2)