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Famitinib

Phase 2

Recurrent Nasopharyngeal Carcinoma | Small molecule | Oncology |Co-Diagnostics, Inc.|Last Updated: Jan 22, 2019

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 Enrollment58
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01392235Famitinib in Treating Patients With Recurrent and/or Metastatic Nasopharyngeal Carcinoma (NPC)PHASE2 COMPLETED 58Jul 1, 2011Aug 1, 2016Jan 22, 20191 China
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Study Endpoints
Primary Endpoints
CBR(Clinical Benefit Rate)
12 weeks

To evaluate the efficacy (clinical benefit rate) of single-agent famitinib in patients with recurrent or metastatic NPC

Secondary Endpoints
ORR (Objective Response Rate)
12 weeks
PFS(Progress Free Survival)
3 years
DCR(Disease Control Rate)
12 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Drug: FamitinibEXPERIMENTAL -
Interventions
NameTypeDescription
FamitinibDRUG25 mg qd p.o. and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Histologically or cytologic confirmed recurrent and/or metastatic nasopharyngeal carcinoma( NPC ) * Have failed for ≥2 lines of chemotherapy * At least one measurable lesion, larger than 10 mm in diameter by spiral CT scan(scanning layer ≤ 5 mm ) * ≥ 18 and ≤ 70 years of age *...

Countries:China
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