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Completed

NCT Number: NCT02514603

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

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

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Key information

Conditions

Neoplasm Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary 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., Chiba, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prexasertib

Drug

Administered IV

Other names: LY2606368

Primary outcomes

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

    Time frame: Cycle 1 (14 day cycle)

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 1 Study of LY2606368 in Japanese Patients With Advanced Solid Tumors

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 3, 2015
Registry last updated
May 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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