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apatinib

Phase 2

Colorectal Neoplasms | Small molecule | Oncology |PLUS THERAPEUTICS, Inc.|Last Updated: Jan 14, 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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment54
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03190616Apatinib in Refractory Colorectal CancerPHASE2 COMPLETED 54 — — Jul 1, 2017Dec 30, 2019Jan 14, 20204 China
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Study Endpoints
Primary Endpoints
Progression-free Survival(PFS)
From assignment of the first subject to 3 months later after the last participant is recruited.The last participant will be recruited before Mar 30,2019

PFS was defined as the time from assignment to disease progression radiological/clinical or death due to any cause, whichever occurs first. Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation.

Secondary Endpoints
Overall Survival (OS)
From assignment of the first subject until 40 death events observed, up to 2 years.
Disease control rate (DCR)
From assignment of the first subject to 3 months later after the last participant is recruited.The last participant will be recruited before Mar 30,2019
Objective response rate(ORR)
From assignment of the first subject to 3 months later after the last participant is recruited.The last participant will be recruited before Mar 30,2019
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
drug,apatinibEXPERIMENTALapatinib 500mg/qd, 28d/cycle
Interventions
NameTypeDescription
apatinibDRUGapatinib 500mg/qd, 28d/cycle
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Histological or cytological documentation of adenocarcinoma of the colon or rectum. All other histological types are excluded. * Subjects with metastatic colorectal cancer(CRC) (Stage IV). * Subjects must have failed at least two lines of prior treatment, which must include a ...

Countries:China
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