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CP-751, 871

Phase 2

Colorectal Neoplasm | Monoclonal antibody | Oncology |Pfizer, Inc.|Last Updated: May 20, 2013

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 Enrollment168
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00560560Study Using CP-751,871 In Patients With Stage IV Colorectal Cancer That Has Not Responded To Previous Anti-Cancer TreatmentsPHASE2 COMPLETED 168 — — Dec 1, 2007Sep 1, 2010May 20, 201312 United States, Spain +1
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Study Endpoints
Primary Endpoints
Estimate of the 6 Month Survival Probability
Baseline up to Month 6

The 6 month survival probability was defined as the probability of survival at 6 months based on the Kaplan-Meier estimate. The time was from date of enrollment to date of death due to any cause. For participants who were last known to be alive, overall survival was censored at the last contact date.

Secondary Endpoints
Overall Survival
From date of enrollment until death or censorship, up to 33 months
Progression-Free Survival (PFS)
Baseline until tumor progression or censorship, up to 33 months. The frequency of tumor assessments was screening, every cycle, end of treatment (within 28 days of last dose of study drug), and follow-up.
Percentage of Participants With Objective Response
Baseline, every cycle (Day 15-21 or according to local standard), end of treatment (within 28 days of last dose of study drug) and follow-up (150 days after last dose of study drug), up to 33 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALSingle arm study
Interventions
NameTypeDescription
CP-751, 871BIOLOGICALHuman IgG2 Monoclonal Antibody. 20mg/kg or 30 mg/kg every 3 weeks for 17 cycles, until progression or unacceptable toxicity develops.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Patients who have stage IV colorectal cancer * Patients whose disease has worsened despite prior anti-cancer therapy * Patients who have satisfactory bonemarrow, kidney and liver function Exclusion Criteria: * Patients who are being simultaneously treated with another anti-c...

Countries:United StatesSpainUnited Kingdom
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