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PF00299804

Phase 1

Carcinoma, Non-Small-Cell Lung | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Mar 12, 2010

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 Enrollment6
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01034748A Radiolabeled Mass Balance Study Of [14C]PF-00299804 In Healthy Male VolunteersPHASE1 COMPLETED 6 — — Jan 1, 2010Feb 1, 2010Mar 12, 20101 United States
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Study Endpoints
Primary Endpoints
Pharmacokinetic parameters: Estimation of PK parameters (Cmax, Tmax, AUClast, AUCinf, t1/2, CL/F and Vd/F, as data permit) for PF 00299804, major metabolites (if possible), and total radioactivity.
1 month
Mass balance: Calculation of % total recovery of total radioactivity in urine and feces; calculation of % dose excreted of major metabolites (if possible).
1 month
Metabolic profiling / metabolite identification: Metabolic profile of PF 00299804 derived from plasma, urine and fecal samples; identification of major metabolites of PF-00299804 in plasma, urine and/or feces if possible.
1 month
Secondary Endpoints
Safety laboratory tests, physical examination, vital signs, ECGs, concomitant medications and adverse event monitoring.
1 month
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
1EXPERIMENTALSingle 45 mg oral dose of \[14C\]PF-00299804
Interventions
NameTypeDescription
[14C]PF00299804DRUGSingle 45 mg oral dose of radiolabelled PF-00299804
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical l...

Countries:United States
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