Clinical Trials /

A Study of LY3023414 in Japanese Participants With Advanced Cancer

NCT02536586

Description:

The main purpose of this study is to evaluate the tolerability of an investigational drug known as LY3023414 in Japanese participants with advanced cancer or cancer that has spread to another part(s) of the body. The study will also explore the safety of the drug. It will measure how much of the drug gets into the blood steam and how long the body takes to get rid of it. It will investigate anti-cancer activity.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Completed

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of LY3023414 in Japanese Participants With Advanced Cancer
  • Official Title: A Phase 1 Study of LY3023414 in Japanese Patients With Advanced Malignancies

Clinical Trial IDs

  • ORG STUDY ID: 15838
  • SECONDARY ID: I6A-JE-CBBH
  • NCT ID: NCT02536586

Conditions

  • Neoplasm

Interventions

DrugSynonymsArms
LY3023414LY3023414

Purpose

The main purpose of this study is to evaluate the tolerability of an investigational drug known as LY3023414 in Japanese participants with advanced cancer or cancer that has spread to another part(s) of the body. The study will also explore the safety of the drug. It will measure how much of the drug gets into the blood steam and how long the body takes to get rid of it. It will investigate anti-cancer activity.

Trial Arms

NameTypeDescriptionInterventions
LY3023414ExperimentalLY3023414 administered orally, twice daily in 21-day cycles. Treatment will continue until disease progression, development of unacceptable toxicity, or other discontinuation criteria are met.
  • LY3023414

Eligibility Criteria

        Inclusion Criteria

          -  Have histological or cytological evidence of a diagnosis of solid tumor that is
             advanced and/or metastatic and must be, in the judgment of the investigator, an
             appropriate candidate for experimental therapy after available standard therapies have
             failed or for whom standard therapy would not be appropriate.

          -  Have the presence of measurable or non-measurable disease as defined by Response
             Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

          -  Have adequate organ and coagulation function.

          -  Have discontinued all previous cancer therapies, and any agents that have not received
             regulatory approval for any indication, for at least 21 days or 5 half-lives prior to
             study treatment, whichever is shorter, and recovered from the acute effects of
             therapy. Participants must have discontinued mitomycin-C or nitrosourea therapy for at
             least 42 days.

          -  Are able to swallow capsules.

          -  Males must agree to use medically approved barrier contraceptive precautions during
             the study and for 3 months following the last dose of study drug.

          -  Females with childbearing potential: Must agree to use medically approved
             contraceptive precautions during the study and for 3 months following the last dose of
             study drug, must have had a negative serum or urine pregnancy test ≤7 days before the
             first dose of study drug.

          -  A breastfeeding woman must not be breastfeeding. If a female who stops breastfeeding
             enters the study, breastfeeding must cease from the day of the first study drug
             administration until at least 3 months after the last administration.

        Exclusion Criteria

          -  Have serious pre-existing medical conditions.

          -  Have symptomatic central nervous system malignancy or metastasis.

          -  Have known acute or chronic leukemia or current hematologic malignancies that, in the
             judgment of the investigator and sponsor, may affect the interpretation of results.

          -  Have a known active fungal, bacterial, and/or known viral infection.

          -  Intolerance to any previous treatment with any phosphatidylinositol 3-kinase
             (PI3K)/AKT/mammalian target of rapamycin (mTOR) inhibitor. Treatment with any
             PI3K/AKT/mTOR inhibitor must have discontinued for at least 21 days or 5 half-lives
             prior to first study drug administration, whichever is shorter, and participants must
             have recovered from the acute effects of therapy.

          -  Have a second primary malignancy that, in the judgment of the investigator, and
             sponsor may affect the interpretation of results.

          -  Participants with active alcohol abuse, as determined by the investigator.

          -  Have a history of heart failure according to New York Heart Association Class ≥3.

          -  Have corrected QT (QTc) interval of >470 milliseconds (msec) on screening
             electrocardiogram (ECG).

          -  Have insulin-dependent diabetes mellitus or a history of gestational diabetes
             mellitus.

          -  Have any evidence of clinically active interstitial lung disease (ILD).
      
Maximum Eligible Age:N/A
Minimum Eligible Age:20 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of Participants with LY3023414 Dose-Limiting Toxicities (DLT)
Time Frame:Cycle 1 (21 days)
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve (AUC) of LY3023414
Time Frame:Predose Cycle 1 through predose Cycle 3. (Cycle = 21 days.)
Safety Issue:
Description:
Measure:Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3023414
Time Frame:Predose Cycle 1 through predose Cycle 3. (Cycle = 21 days.)
Safety Issue:
Description:
Measure:Proportion of Participants With Best Overall Response (OR) of Partial Response (PR) or Complete Response (CR) (Overall Response Rate [ORR])
Time Frame:Baseline through study completion (estimated as up to five months)
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:Eli Lilly and Company

Last Updated

July 20, 2018