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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

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment17

FDA Designations

No designations recorded

Clinical trial landscape

SCH 721015 with SCH 209702 · 1 trial · 1 indication

Phase 1 1
NCT00536588A Safety and Tolerability Study of SCH 721015 in Patients With Transitional Cell Carcinoma of the Bladder (Study P03816)Bladder Neoplasms
COMPLETED17 Analytics
PHASE1COMPLETED
A Safety and Tolerability Study of SCH 721015 in Patients With Transitional Cell Carcinoma of the Bladder (Study P03816)
Bladder NeoplasmsUnlock trial analytics

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 to 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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Frequently asked questions about SCH 721015 with SCH 209702

What is SCH 721015 with SCH 209702 used for?

SCH 721015 with SCH 209702 is an investigational gene therapy being studied for the treatment of bladder neoplasms, specifically transitional cell carcinoma of the bladder. It is in Phase 1 clinical development and has not been approved by the FDA.

Who makes SCH 721015 with SCH 209702?

SCH 721015 with SCH 209702 is being developed by Merck & Company, Inc., which is publicly traded under the ticker symbol MRK on the New York Stock Exchange.

What phase is SCH 721015 with SCH 209702 in?

SCH 721015 with SCH 209702 is in Phase 1 clinical development. It is an investigational gene therapy for bladder neoplasms and is not yet approved for commercial use.

What clinical trials is SCH 721015 with SCH 209702 in?

SCH 721015 with SCH 209702 has one completed Phase 1 clinical trial, identified as NCT00536588, which evaluated its safety and tolerability in patients with transitional cell carcinoma of the bladder. The trial enrolled 17 participants.

Is SCH 721015 with SCH 209702 the same as SCH 209702?

SCH 721015 with SCH 209702 is a combination therapy that includes SCH 209702 as one of its components. The drug name refers to the combined regimen being studied for bladder cancer.