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A Study of Merestinib (LY2801653) in Japanese Participants With Advanced or Metastatic Cancer

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT03027284
Collaborator
(none)
19
Enrollment
2
Locations
3
Arms
37.4
Actual Duration (Months)
9.5
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of this study is to evaluate tolerability of merestinib monotherapy or in combination with other anti-cancer agents in Japanese participants with advanced and/or metastatic cancer.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I Study of Merestinib Monotherapy or in Combination With Other Anti-Cancer Agents in Japanese Patients With Advanced and/or Metastatic Cancer
Actual Study Start Date :
Feb 3, 2017
Actual Primary Completion Date :
Jun 20, 2019
Actual Study Completion Date :
Mar 17, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Merestinib (Part A Dose Level 1)

Merestinib administered orally. Treatment will continue until disease progression, development of unacceptable toxicity, or other discontinuation criteria are met.

Drug: Merestinib
Administered orally
Other Names:
  • LY2801653

    		•
    Experimental: Merestinib (Part A Dose Level 2)

    Merestinib administered orally. Treatment will continue until disease progression, development of unacceptable toxicity, or other discontinuation criteria are met.

    Drug: Merestinib
    Administered orally
    Other Names:
  • LY2801653

    		•
    Experimental: Merestinib + Cisplatin + Gemcitabine (Part B)

    Merestinib administered orally with cisplatin and gemcitabine administered intravenously (IV). Treatment will continue until disease progression, development of unacceptable toxicity, or other discontinuation criteria are met, but Cisplatin and gemcitabine treatment will be limited to a maximum of 8 cycles.

    Drug: Merestinib
    Administered orally
    Other Names:
  • LY2801653

    • Drug: Cisplatin
    Administered IV

    Drug: Gemcitabine
    Administered IV
    Other Names:
  • LY188011

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants with Merestinib Dose-Limiting Toxicities (DLTs) [Cycle 1 (Part A = 28 Days or Part B = 21 Days)]

      Number of participants with DLTs

    Secondary Outcome Measures

    1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Merestinib and its Metabolites [Predose Cycle 1 Throughout the First 2 Cycles (Part A = 28-Day Cycles, Part B = 21-Day Cycles)]

      PK: Cmax of merestinib and its metabolites

    2. PK: Area Under the Concentration Time Curve (AUC) of Merestinib and its Metabolites [Predose Cycle 1 Throughout the First 2 Cycles (Part A = 28-Day Cycles, Part B = 21-Day Cycles)]

      PK: AUC of merestinib and its metabolites

    3. Objective Response Rate (ORR): Percentage of Participants With a Complete or Partial Response [Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Estimated as up to 8 Months)]

      ORR: Percentage of participants with a complete or partial response

    4. Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of Complete Response, Partial Response, and Stable Disease [Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Estimated as up to 8 Months)]

      DCR: Percentage of participants with a best overall response of complete response, partial response, and stable disease

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Part A: Histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic (solid tumors or non-Hodgkin's lymphoma).

    • Part B: Biliary tract carcinoma that is unresectable, recurrent, or metastatic. The participant must not have received prior systemic front-line therapy for metastatic or resectable disease.

    • Part A: Measurable or nonmeasurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or Cheson Criteria.

    • Part B: Measurable disease as defined by RECIST v1.1.

    • Adequate organ function including hematologic, hepatic and renal.

    • Eastern Cooperative Oncology Group (ECOG) scale of 0 or 1.

    • Are able to swallow tablets.

    • For participants in Part B, a tumor tissue sample is mandatory for biomarker analysis.

    • 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 a chronic underlying infection.

    • Have symptomatic central nervous system malignancy or metastasis.

    • Have an active fungal, bacterial, and/or known viral infection.

    • Part B: Have mixed hepatocellular biliary tract carcinoma histology.

    • Have liver cirrhosis with a Child-Pugh stage of B or higher, or have received a liver transplant.

    • Have a history of congestive heart failure with New York Heart Association (NYHA) class greater than 2, unstable angina, or have recent history of myocardial infarction, transient ischemic attacks, stroke, or arterial or venous vascular disease.

    • Have a corrected QT interval >470 milliseconds as calculated be the Fredericia equation.

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

    • Have any evidence of clinically active interstitial lung disease (ILD).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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 277 8577
    2 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 Tokyo Japan 104-0045

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT03027284
    Other Study ID Numbers:
    • 16330
    • I3O-JE-JSBG
    First Posted:
    Jan 23, 2017
    Last Update Posted:
    May 19, 2020
    Last Verified:
    May 15, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Eli Lilly and Company
    Neoplasm
    Additional relevant MeSH terms:
    Carcinoma
    Cholangiocarcinoma
    Neoplasm Metastasis
    Neoplasms
    Neoplasms, Second Primary
    Urinary Bladder Neoplasms
    Gemcitabine

    Study Results

    No Results Posted as of May 19, 2020