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

May 18, 2020 updated by: Eli Lilly and Company

A Phase I Study of Merestinib Monotherapy or in Combination With Other Anti-Cancer Agents in Japanese Patients With Advanced and/or Metastatic Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chiba, Japan, 277 8577
        • 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
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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: Cisplatin
Administered IV
Drug: Gemcitabine
Administered IV
Other Names:
  • LY188011
Drug: Merestinib
Administered orally
Other Names:
  • LY2801653

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Merestinib Dose-Limiting Toxicities (DLTs)
Time Frame: Cycle 1 (Part A = 28 Days or Part B = 21 Days)
Number of participants with DLTs
Cycle 1 (Part A = 28 Days or Part B = 21 Days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Merestinib and its Metabolites
Time Frame: 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
Predose Cycle 1 Throughout the First 2 Cycles (Part A = 28-Day Cycles, Part B = 21-Day Cycles)
PK: Area Under the Concentration Time Curve (AUC) of Merestinib and its Metabolites
Time Frame: 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
Predose Cycle 1 Throughout the First 2 Cycles (Part A = 28-Day Cycles, Part B = 21-Day Cycles)
Objective Response Rate (ORR): Percentage of Participants With a Complete or Partial Response
Time Frame: 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
Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Estimated as up to 8 Months)
Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of Complete Response, Partial Response, and Stable Disease
Time Frame: 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
Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Estimated as up to 8 Months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2017

Primary Completion (Actual)

June 20, 2019

Study Completion (Actual)

March 17, 2020

Study Registration Dates

First Submitted

January 19, 2017

First Submitted That Met QC Criteria

January 19, 2017

First Posted (Estimate)

January 23, 2017

Study Record Updates

Last Update Posted (Actual)

May 19, 2020

Last Update Submitted That Met QC Criteria

May 18, 2020

Last Verified

May 15, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16330
  • I3O-JE-JSBG (Other Identifier: Eli Lilly and Company)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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