Clinical trial NCT02514603: A Study of Prexasertib (LY2606368) in Japanese Participants With Advanced Cancers
Official title: A Phase 1 Study of LY2606368 in Japanese Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasm
Keywords: Neoplasm metastasis
Checkpoint Kinase 1
CHK1
CHK1 inhibitor
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2015-08-03
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Number of Participants with Prexasertib Dose-Limiting Toxicities (DLT)
timeFrame: Cycle 1 (14 day cycle)
Secondary outcomes:
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Prexasertib
timeFrame: Pre-dose up to 7 Days Post Treatment in Cycle 1/2 (Approximately 7 Days)
measure: Pharmacokinetics (PK): Area Under Curve (AUC) of Prexasertib
timeFrame: Pre-dose up to 7 Days Post Treatment in Cycle1/2 (Approximately 7 Days)
measure: Percentage of Participants with a Tumor Response
timeFrame: Baseline to Study Completion (Approximately 24 weeks)
Other outcomes:
Locations:
city: Chiba
country: Japan
facility: 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.
city: Tokyo
country: Japan
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: