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Edotecarin

Phase 3

Glioblastoma | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Apr 1, 2008

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
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment118
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00068952Study of IV Edotecarin Vs Temozolomide or Carmustine (BCNU) or Lomustine (CCNU) in Patients With Glioblastoma MultiformePHASE3 COMPLETED 118 — — Aug 1, 2003Mar 1, 2006Apr 1, 200852 United States, Australia +12
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Study Endpoints
Primary Endpoints
To compare the overall survival associated with edotecarin versus that associated with temozolomide or BCNU or CCNU for the treatment of patients with GBM at first relapse previously treated with alkylator-based (neo)adjuvant therapy
Secondary Endpoints
To assess measures of tumor control To evaluate measures of clinical benefit To assess the safety profile of edotecarin To assess the PK profile of edotecarin and the potential for drug interactions between anticonvulsants and edotecarin
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
EdotecarinDRUG -
TemozolomideDRUG -
Carmustine (BCNU)DRUG -
Lomustine (CCNU)DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites52

Inclusion Criteria: * Must have biopsy-proven GBM. First relapse (progression or recurrence) of GBM after surgery (or biopsy) and treatment with radiotherapy (conventional fractionated external beam) and chemotherapy (temozolomide- or nitrosurea-based therapy) * Must have past biopsy samples availa...

Countries:United StatesAustraliaAustriaCanadaCroatiaCzechiaFranceGermanyIndiaItalyRussiaSouth AfricaSpain
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