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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
19
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, Japan
Number of Participants with Merestinib Dose-Limiting Toxicities (DLTs)
Number of participants with DLTs
Time frame: Cycle 1 (Part A = 28 Days or Part B = 21 Days)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Merestinib and its Metabolites
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)
PK: Area Under the Concentration Time Curve (AUC) of Merestinib and its Metabolites
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)
Objective Response Rate (ORR): Percentage of Participants With a Complete or Partial Response
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)
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
Time frame: Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Estimated as up to 8 Months)
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