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PELITREXOL/AG-2037

Phase 2

Colorectal Neoplasms | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Nov 9, 2006

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment56
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00078468Study of the GARFT Inhibitor AG2037 in Patients With Metastatic Colorectal Cancer Who Failed TreatmentPHASE2 COMPLETED 56 — — Dec 1, 2003Sep 1, 2004Nov 9, 20064 United States
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Study Endpoints
Primary Endpoints
To determine the overall objective response rate (complete and partial responses) of AG-2037 in patients with metastatic colorectal cancer who failed treatment with 5FU/LV regimen and up to one other chemotherapeutic regimen.
Secondary Endpoints
To estimate time to progression (TTP).
To evaluate the overall survival (1-year) of patients treated with AG-2037.
To assess changes in patient reported outcomes using health-related quality of life questionnaires.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
PELITREXOL/AG-2037DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum * Stage IV or recurrent disease * Measurable disease * Disease progression or recurrence during or after completion of prior first-line chemotherapy with fluorouracil and leucovorin calc...

Countries:United States
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