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Merestinib

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: May 19, 2020

Success Probability
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Market & Valuation
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Trial Design
RandomizedCONTROLLED
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical trial landscape

Merestinib · 2 trials · 8 indications

Phase 1 2
NCT03027284A Study of Merestinib (LY2801653) in Japanese Participants With Advanced or Metastatic CancerAdvanced Cancer
COMPLETED19 Analytics
NCT02779738A Study of Merestinib (LY2801653) in Healthy ParticipantsHealthy
COMPLETED24 Analytics
PHASE1COMPLETED
A Study of Merestinib (LY2801653) in Japanese Participants With Advanced or Metastatic Cancer
Advanced Cancer
NCT0302728419
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PHASE1COMPLETED
A Study of Merestinib (LY2801653) in Healthy Participants
Healthy
NCT0277973824
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Study Endpoints
Primary Endpoints
Number of Participants with Merestinib Dose-Limiting Toxicities (DLTs)
Cycle 1 (Part A = 28 Days or Part B = 21 Days)

Number of participants with DLTs

Pharmacokinetics (PK): Maximum Concentration (Cmax) for Merestinib for High-Fat Meal and Fasted State
Predose through 120 hours after administration of study drug
Pharmacokinetics: Maximum Concentration (Cmax) for Merestinib for Standard Meal and Fasted State
Predose through 120 hours after administration of study drug
Pharmacokinetics: Area Under The Concentration Curve AUC(0-∞) for Merestinib for High-Fat Meal and Fasted State
Predose through 120 hours after administration of study drug
Pharmacokinetics: Area Under The Concentration Curve AUC(0-∞) for Merestinib for Standard Meal and Fasted State
Predose through 120 hours after administration of study drug
Secondary Endpoints
Pharmacokinetics (PK): Maximum Concentration (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
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
Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Estimated as up to 8 Months)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Merestinib (Part A Dose Level 1)EXPERIMENTALMerestinib administered orally. Treatment will continue until disease progression, development of unacceptable toxicity, or other discontinuation criteria are met.
Merestinib (Part A Dose Level 2)EXPERIMENTALMerestinib administered orally. Treatment will continue until disease progression, development of unacceptable toxicity, or other discontinuation criteria are met.
Merestinib + Cisplatin + Gemcitabine (Part B)EXPERIMENTALMerestinib 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.
Merestinib FastedEXPERIMENTALSingle dose of merestinib administered in fasted state in one of three periods
Merestinib Standard MealEXPERIMENTALSingle dose of merestinib administered with a standard meal in one of three periods
Merestinib High-Fat MealEXPERIMENTALSingle dose of merestinib administered with a high-fat meal in one of three periods
Interventions
NameTypeDescription
MerestinibDRUGAdministered orally
CisplatinDRUGAdministered IV
GemcitabineDRUGAdministered IV
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Eligibility Criteria
Age Range20 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

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 sys...

Countries:JapanUnited States
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