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.
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
Interventions
Drug | Synonyms | Arms |
---|
LY3023414 | | LY3023414 |
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
Name | Type | Description | Interventions |
---|
LY3023414 | Experimental | LY3023414 administered orally, twice daily in 21-day cycles. Treatment will continue until disease progression, development of unacceptable toxicity, or other discontinuation criteria are met. | |
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 24, 2018