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

Lilly

Status and phase: Completed; Phase 1

Conditions: Neoplasm

Treatments: Drug: Prexasertib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02514603

16018

I4D-JE-JTJK (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Prexasertib

Experimental group

Description:

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.

Treatment:

Drug: Prexasertib