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SCH 721015 with SCH 209702

Phase 1

Bladder Neoplasms | Gene therapy | Oncology |Merck & Company, Inc.|Last Updated: Mar 27, 2015

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
UNCONTROLLED
Total Trials1
Total Enrollment17
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00536588A Safety and Tolerability Study of SCH 721015 in Patients With Transitional Cell Carcinoma of the Bladder (Study P03816)PHASE1 COMPLETED 17Sep 1, 2006Aug 1, 2009Mar 27, 2015 -
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Study Endpoints
Primary Endpoints
Adverse events, laboratory safety tests, dose-limiting toxicity
CBC/chemistry: predose, Days 1-3, 7, 14, 21, & 28, Week 12.
Secondary Endpoints
Timed urine collections for IFNα2b excretion & IP-10.
Days 1-7, 10, 14, 21, & 28/29.
Urine samples for SCH 721015 DNA content.
Predose, Days 1-7 & 14.
Blood samples for SCH 721015 DNA; SCH 209702, & IFNα2b levels; antiadenoviral & anti-IFNα2b antibodies
Pre- & postdose for SCH 721015 DNA; SCH 721015, & IFNα2b levels; & postdose for antibodies.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SCH 721015 with SCH 209702EXPERIMENTAL -
Interventions
NameTypeDescription
SCH 721015 with SCH 209702GENETICEach subject receives a single intravesical administration of SCH 721015 with SCH 209702 at dose levels of 1 x 10\^9 to 3 x 10\^11 particles/mL (based on assessment of tolerability, intermediate dose levels may be used).
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Histologically proven recurrent transitional cell carcinoma of the bladder, Stage Tis, Ta. * Patients with recurrent T1 disease who do not wish to have cystectomy. * Subjects must have failed at least two prior courses of BCG with or without recombinant interferon alpha admini...

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