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Epitinib

Phase 1

Solid Tumor | Small molecule | Oncology |HUTCHMED (China) Limited|Last Updated: Feb 17, 2020

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment108
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02590952A Phase I Study of Epitinib(HMPL-813) in Patients With Advanced Solid TumorsPHASE1 COMPLETED 108Oct 31, 2011Apr 30, 2019Feb 17, 20201 China
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Study Endpoints
Primary Endpoints
incidence of all types/grades of adverse events
from first patient in till 30 days after the last patient last visit. It is estimated that last patient last visit happens in Oct 2016.

for each patient, adverse events are collected from the date of consent until 30 days after trial discontinuation

Secondary Endpoints
Objective Response Rate
An average of one year
Area under the plasma concentration versus time curve (AUC)
At single-dose stage (day 1-day 7): predose, 0.5,1, 2, 3, 4, 5, 6, 8,12,24, 36, 48, 72, 144 hours post-dose.
Peak Plasma Concentration (Cmax)
At single-dose stage (day 1-day 7): predose, 0.5,1, 2, 3, 4, 5, 6, 8,12,24, 36, 48, 72, 144 hours post-dose.
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
EpitinibEXPERIMENTALEpitinib is a capsule in the form of 5mg,20 mg, and 40 mg. Route: oral (daily)
Interventions
NameTypeDescription
EpitinibDRUGThe starting daily dose is 20 mg. Dose escalation will follow daily dose of 40 mg,80 mg, 120 mg, 160 mg, 200 mg, and 250 mg. A 3+3 design applies to this study. Patients will continue taking Epitinib until they experience intolerable adverse events or their diseases are confirmed to be progressed.
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Histopathology confirmed solid tumors * Failed to standard treatment or no standard treatments for uncontrolled, recurrent and/or metastatic advance tumor (whatever previous surgery conditions) * Age 18-70 * ECOG 0-2, and no worse within 7days * Life expected \> 12 weeks * wri...

Countries:China
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