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CPG 7909

Phase 2

Carcinoma, Melanoma | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Feb 10, 2009

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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment184
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00070642CPG 7909 Injection in MelanomaPHASE2 COMPLETED 184Dec 1, 2003Dec 1, 2005Feb 10, 2009 -
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Study Endpoints
Primary Endpoints
Phase II: Assess the anti-neoplastic activity, as determined by overall response rate (complete plus partial responses) according to the RECIST criteria.
indeterminate
Phase III: Evaluate and compare the survival time of the two treatment groups, as selected in Phase II.
Indeterminate
Secondary Endpoints
Phase III: Assess the overall response rate
indeterminate
Asses the degree of clinical benefit defined as the proportion of patients experiencing complete and partial responses as well as stable disease.
indeterminate
Determine the duration of response.
indeterminate
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CPG 7909 Injection plus chemotherapyEXPERIMENTALCPG 7909 Injection plus DTIC
Chemotherapy aloneACTIVE_COMPARATORdacarbazine
CPG 7909 Injection 10 mgEXPERIMENTAL -
CPG 7909 Injection 40 mgEXPERIMENTAL -
Interventions
NameTypeDescription
CPG 7909 InjectionDRUGCPG 7909 Injection administered subcutaneously at a dose of 40 mg weekly.
dacarbazineDRUGdacarbazine 850mg/m2 in three-week cycles until disease progression
ChemotherapyDRUGChemotherapy in three-week cycles until disease progression: dacarbazine 850mg/m2
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Histologically or cytologically confirmed melanoma that is metastatic. * Measurable disease according to the RECIST criteria. * Karnofsky Performance Status of \> 70. Exclusion Criteria: * Prior treatment with anti-neoplastic biologic or chemotherapy for recurrent or metasta...

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