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REOLYSIN

Phase 3

Carcinoma, Squamous Cell of the Head and Neck | Monoclonal antibody | Oncology |Oncolytics Biotech Inc.|Last Updated: Nov 5, 2014

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment181
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01166542Efficacy Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Platinum-Refractory Head and Neck CancersPHASE3 COMPLETED 167 — — Jun 1, 2010May 1, 2014Nov 5, 201477 United States, Belgium +11
NCT00753038Phase 2 Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Patients With Head and Neck CarcinomaPHASE2 COMPLETED 14 — — Aug 1, 2008May 1, 2013Nov 4, 20142 United States
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Study Endpoints
Primary Endpoints
Overall survival
every 3 months until death.
Determine the objective response rate (complete response (CR) + partial response (PR)) of the treatment regimen in the study population
For PR or CR, changes in tumor measurements must be confirmed 4 weeks after the criteria for response are first met.
Secondary Endpoints
Progression-free survival
Assessed every 6 weeks until disease progression or death.
Objective response (complete response (CR) + partial response (PR)) rate and duration
Evaluation of response is conducted every 6 weeks on and after study. Duration of objective response is measured from the time measurement criteria are first met for CR or PR until recurrent or progressive disease is objectively documented.
Number of participants with adverse events as a measure of safety and tolerability of REOLYSIN when administered in combination with paclitaxel and carboplatin.
Within 30 days of the last dose of REOLYSIN.
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
REOLYSIN, paclitaxel, carboplatinACTIVE_COMPARATOR -
placebo, paclitaxel, carboplatinPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
REOLYSINBIOLOGICAL3E10 TCID50, 1 hour intravenous infusion, administered on Days 1, 2, 3, 4 and 5 of a 21 day cycle
CarboplatinDRUG5 AUC mg/mL min, 30 min intravenous infusion, given on Day 1 of a 21 day cycle
PaclitaxelDRUG175 mg/m2, 3 hour intravenous infusion, given on Day 1 of a 21 day cycle
PlaceboDRUGPlacebo
REOLYSIN®BIOLOGICAL3E10 TCID50, 1 hour intravenous infusion, administered on Days 1, 2, 3, 4 and 5 of a 21 day cycle
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites77

Inclusion Criteria: Each patient MUST: * have recurrent or metastatic (R/M) histologically confirmed squamous cell carcinoma (SCC) of the head and neck (oropharynx, oral cavity, larynx, hypopharynx) or squamous cell nasopharynx cancer (NPC) with distal metastasis(es) and no secondary cancers (Patie...

Countries:United StatesBelgiumCanadaFranceGermanyGreeceHungaryItalyPolandRussiaSloveniaSpainUnited Kingdom
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