Back to resultsA Study of Merestinib (LY2801653) in Japanese Participants With Advanced or Metastatic Cancer
Primary Purpose
Advanced Cancer, Metastatic Cancer, Biliary Tract Carcinoma
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Merestinib
Cisplatin
Gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Cancer focused on measuring Neoplasm
Eligibility Criteria
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).
Sites / Locations
- 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
- 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
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Merestinib (Part A Dose Level 1)
Merestinib (Part A Dose Level 2)
Merestinib + Cisplatin + Gemcitabine (Part B)
Arm Description
Merestinib administered orally. Treatment will continue until disease progression, development of unacceptable toxicity, or other discontinuation criteria are met.
Merestinib administered orally. Treatment will continue until disease progression, development of unacceptable toxicity, or other discontinuation criteria are met.
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.
Outcomes
Primary Outcome Measures
Number of Participants with Merestinib Dose-Limiting Toxicities (DLTs)
Number of participants with DLTs
Secondary Outcome Measures
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Merestinib and its Metabolites
PK: Cmax of merestinib and its metabolites
PK: Area Under the Concentration Time Curve (AUC) of Merestinib and its Metabolites
PK: AUC of merestinib and its metabolites
Objective Response Rate (ORR): Percentage of Participants With a Complete or Partial Response
ORR: Percentage of participants with a complete or partial response
Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of Complete Response, Partial Response, and Stable Disease
DCR: Percentage of participants with a best overall response of complete response, partial response, and stable disease
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03027284
Brief Title
A Study of Merestinib (LY2801653) in Japanese Participants With Advanced or Metastatic Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 15, 2020
Overall Recruitment Status
Completed
Study Start Date
February 3, 2017 (Actual)
Primary Completion Date
June 20, 2019 (Actual)
Study Completion Date
March 17, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Cancer, Metastatic Cancer, Biliary Tract Carcinoma, Cholangiocarcinoma, Gall Bladder Carcinoma, Solid Tumor, Non-Hodgkin's Lymphoma
Keywords
Neoplasm
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Merestinib (Part A Dose Level 1)
Arm Type
Experimental
Arm Description
Merestinib administered orally. Treatment will continue until disease progression, development of unacceptable toxicity, or other discontinuation criteria are met.
Arm Title
Merestinib (Part A Dose Level 2)
Arm Type
Experimental
Arm Description
Merestinib administered orally. Treatment will continue until disease progression, development of unacceptable toxicity, or other discontinuation criteria are met.
Arm Title
Merestinib + Cisplatin + Gemcitabine (Part B)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Merestinib
Other Intervention Name(s)
LY2801653
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Administered IV
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
LY188011
Intervention Description
Administered IV
Primary Outcome Measure Information:
Title
Number of Participants with Merestinib Dose-Limiting Toxicities (DLTs)
Description
Number of participants with DLTs
Time Frame
Cycle 1 (Part A = 28 Days or Part B = 21 Days)
Secondary Outcome Measure Information:
Title
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Merestinib and its Metabolites
Description
PK: 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)
Title
PK: Area Under the Concentration Time Curve (AUC) of Merestinib and its Metabolites
Description
PK: 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)
Title
Objective Response Rate (ORR): Percentage of Participants With a Complete or Partial Response
Description
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)
Title
Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of Complete Response, Partial Response, and Stable Disease
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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
City
Chiba
ZIP/Postal Code
277 8577
Country
Japan
Facility Name
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
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
34499416
Citation
Doi T, Yamamoto N, Naito Y, Kuboki Y, Koyama T, Piao Y, Tsujimoto N, Asou H, Inoue K, Kondo S. Merestinib monotherapy or in combination for japanese patients with advanced and/or metastatic cancer: A phase 1 study. Cancer Med. 2021 Oct;10(19):6579-6589. doi: 10.1002/cam4.4110. Epub 2021 Sep 9.
Results Reference
derived
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A Study of Merestinib (LY2801653) in Japanese Participants With Advanced or Metastatic Cancer
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