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genexolPM + cisplatin

Phase 2

Locally Advanced Head and Neck Squamous Cell Carcinoma | Small molecule | Oncology |Solid Biosciences Inc.|Last Updated: Dec 8, 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 Enrollment53
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01689194Efficacy Study of Genexol-PM and Cisplatin in Locally Advanced Head and Neck CancerPHASE2 COMPLETED 53 — — Feb 1, 2013Aug 31, 2017Dec 8, 20202 South Korea
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Study Endpoints
Primary Endpoints
response rate
every 2 cycles, 6wk later after chemotherapy

RECIST

Secondary Endpoints
Locoregional control rate
every 3wk (every cycle)
Quality of life
every 3wk (every cycle)
safety
every 3wk (every cycle)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
genexolPM + cisplatinEXPERIMENTAL -
Interventions
NameTypeDescription
genexolPM + cisplatinDRUG -
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * locally advanced head and neck squamous cell carcinoma * oral cavity, oropharynx, hypopharynx, larynx * measurable lesion * unresectable * age 18 or more * ECOG 0 or 1 Exclusion Criteria: * distant metastasis * pregnancy * prior chemotherapy or radiation therapy * 2ndary mal...

Countries:South Korea
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