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CI-1033

Phase 2

Breast Neoplasms | Small molecule | Oncology |Pfizer, Inc.|Last Updated: May 4, 2007

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 Enrollment168
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00051051A Phase II Study of CI-1033 in Treating Patients With Metastatic (Stage IV) Breast CancerPHASE2 COMPLETED 168Dec 1, 2002May 1, 2005May 4, 200766 United States, Belgium +7
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Study Endpoints
Primary Endpoints
The primary objective is to assess the antitumor activity of CI 1033 in patients with metastatic breast cancer.
Secondary Endpoints
Secondary objectives include an assessment of safety and patient reported outcomes (eg, quality of life [QOL])
correlations between erbB expression and efficacy
exploratory analyses of soluble erbB-2 or other biomarkers
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
CI-1033DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites66

Inclusion Criteria: * Female, at least 18 years of age * Histologically confirmed diagnosis of breast cancer * Metastatic (Stage IV) disease * Progressive or recurrent disease following the most recent therapy * No more than 2 different, prior cytotoxic chemotherapy regimens for metastatic disease ...

Countries:United StatesBelgiumCanadaFranceIrelandItalySpainSwedenUnited Kingdom
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