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PF-03732010

Phase 1

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

PF-03732010 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Nov 2007

PF-03732010 target and mechanism

Molecular targetCDH3
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment43

FDA Designations

No designations recorded

PF-03732010 clinical trials

PF-03732010 · 1 trial · 1 indication

Phase 1 1
NCT00557505A Study Of PF-03732010 In Patients With Advanced Solid TumorsNeoplasms
COMPLETED43 Analytics
PHASE1COMPLETED
A Study Of PF-03732010 In Patients With Advanced Solid Tumors
NeoplasmsUnlock trial analytics

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
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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.
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Eligibility Criteria

Age Range18 Years to 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
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Frequently asked questions about PF-03732010

What is PF-03732010?

PF-03732010 is an investigational small molecule developed by Pfizer, Inc. for the treatment of advanced solid tumors and other neoplasms. It was studied in a single Phase 1 clinical trial in patients with advanced solid tumors. It is an experimental agent and is not an approved medicine.

What does PF-03732010 target?

PF-03732010 targets CDH3, also known as P-cadherin, and acts as an inhibitor of this target. CDH3 is a cell adhesion protein that is overexpressed in several tumor types, which made it an attractive target for an anti-cancer therapy. The compound was designed to inhibit CDH3 activity in tumor cells.

Who makes PF-03732010?

PF-03732010 is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the Phase 1 study of the compound in patients with advanced solid tumors. The drug remains an investigational Pfizer oncology asset.

What phase is PF-03732010 in?

PF-03732010 is in Phase 1 development. It has completed one Phase 1 clinical trial in patients with advanced solid tumors, and no later-stage trials have been conducted. The compound is investigational and has not been approved by the FDA or any other regulatory agency for any indication.

What clinical trials is PF-03732010 in?

PF-03732010 was evaluated in one Phase 1 trial, NCT00557505, titled A Study Of PF-03732010 In Patients With Advanced Solid Tumors. That trial is completed and enrolled 43 patients across the United States, Australia, and South Korea. It was an uncontrolled study without randomization or blinding.

What is PF-03732010 used for in neoplasms?

PF-03732010 was studied for the treatment of advanced solid tumors, which fall under the broader category of neoplasms. The Phase 1 trial enrolled 43 adult patients of any sex with advanced solid tumors. Because the compound is investigational, it is not currently used as a marketed treatment for neoplasms.