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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03027284
Other study ID # 16330
Secondary ID I3O-JE-JSBG
Status Completed
Phase Phase 1
First received
Last updated
Start date February 3, 2017
Est. completion date March 17, 2020

Study information

Verified date May 15, 2020
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date March 17, 2020
Est. primary completion date June 20, 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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 Design


Intervention

Drug:
Merestinib
Administered orally
Cisplatin
Administered IV
Gemcitabine
Administered IV

Locations

Country Name City State
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 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

Sponsors (1)

Lead Sponsor Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants with Merestinib Dose-Limiting Toxicities (DLTs) Number of participants with DLTs Cycle 1 (Part A = 28 Days or Part B = 21 Days)
Secondary Pharmacokinetics (PK): Maximum Concentration (Cmax) of Merestinib and its Metabolites 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)
Secondary PK: Area Under the Concentration Time Curve (AUC) of Merestinib and its Metabolites 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)
Secondary Objective Response Rate (ORR): Percentage of Participants With a Complete or Partial Response 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)
Secondary 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 Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Estimated as up to 8 Months)
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