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A Study of Merestinib (LY2801653) in Japanese Participants With Advanced or Metastatic 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: NCT03027284
Recruitment Status : Active, not recruiting
First Posted : January 23, 2017
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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
Advanced Cancer Metastatic Cancer Biliary Tract Carcinoma Cholangiocarcinoma Gall Bladder Carcinoma Solid Tumor Non-Hodgkin's Lymphoma Drug: Merestinib Drug: Cisplatin Drug: Gemcitabine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 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 : February 3, 2017
Actual Primary Completion Date : June 20, 2019
Estimated Study Completion Date : March 31, 2020


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 Name: 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 Name: 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 Name: LY2801653

Drug: Cisplatin
Administered IV

Drug: Gemcitabine
Administered IV
Other Name: LY188011




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03027284


Locations
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Japan
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
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
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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

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03027284     History of Changes
Other Study ID Numbers: 16330
I3O-JE-JSBG ( Other Identifier: Eli Lilly and Company )
First Posted: January 23, 2017    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 1, 2019

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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:
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Carcinoma
Lymphoma, Non-Hodgkin
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Cholangiocarcinoma
Urinary Bladder Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Lymphoma
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplastic Processes
Pathologic Processes
Adenocarcinoma
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Cisplatin
Gemcitabine
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents