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A Study of LY3023414 in Japanese Participants With Advanced Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02536586
Recruitment Status : Completed
First Posted : September 1, 2015
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE August 28, 2015
First Posted Date  ICMJE September 1, 2015
Last Update Posted Date July 24, 2018
Study Start Date  ICMJE September 2015
Actual Primary Completion Date February 9, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2015)
Number of Participants with LY3023414 Dose-Limiting Toxicities (DLT) [ Time Frame: Cycle 1 (21 days) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02536586 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2015)
  • Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve (AUC) of LY3023414 [ Time Frame: Predose Cycle 1 through predose Cycle 3. (Cycle = 21 days.) ]
  • Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3023414 [ Time Frame: Predose Cycle 1 through predose Cycle 3. (Cycle = 21 days.) ]
  • 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) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of LY3023414 in Japanese Participants With Advanced Cancer
Official Title  ICMJE A Phase 1 Study of LY3023414 in Japanese Patients With Advanced Malignancies
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neoplasm
Intervention  ICMJE Drug: LY3023414
LY3023414 administered orally.
Study Arms  ICMJE Experimental: LY3023414
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.
Intervention: Drug: LY3023414
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 28, 2015)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 9, 2017
Actual Primary Completion Date February 9, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02536586
Other Study ID Numbers  ICMJE 15838
I6A-JE-CBBH ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: 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) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP