Recent Updates
Recently added Catalysts

PF-03732010

Phase 1

Neoplasms | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Mar 26, 2012

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment43
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00557505A Study Of PF-03732010 In Patients With Advanced Solid TumorsPHASE1 COMPLETED 43Dec 1, 2007Feb 1, 2011Mar 26, 20123 United States, Australia +1
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Maximum Tolerated Dose (MTD)
Baseline up to end of treatment (EOT) or withdrawal assessed up to Day 7 of last cycle
Recommended Phase-2 Dose (RP2D)
Baseline up to EOT or withdrawal assessed up to Day 7 of last cycle
Secondary Endpoints
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-28 Day)]
0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal
Time to Reach Maximum Observed Serum Concentration (Tmax)
0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal
Minimum Observed Serum Trough Concentration (Cmin)
0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal
Unlock Study Endpoints
Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PF-03732010EXPERIMENTALSingle Arm study
Interventions
NameTypeDescription
PF-03732010DRUGIV infusion. Escalating dose levels, starting at 0.5 mg/kg to Maximum Tolerated Dose. Cycle length of 4 weeks for first cycle, and 2 weekly for subsequently cycles was originally explored, yet based on emerging PK data the Cycle 1 duration is 2 weeks and then weekly. Number of Cycles: Until Progression or unacceptable toxicity develops.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Advanced solid tumors refractory to (or intolerant of) established therapy known to provide clinical benefit, or for which there is no standard therapy * Age \>= 18 years of age * Adequate bone marrow function as defined by: absolute neutrophil count (ANC) ≥1500/uL, hemoglobin...

Countries:United StatesAustraliaSouth Korea
Unlock Eligibility Criteria