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PF-03732010

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment43

FDA Designations

No designations recorded

Clinical trial landscape

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 used for?

PF-03732010 is an investigational small molecule being developed for the treatment of neoplasms, which are abnormal growths of tissue that can be benign or malignant. It was studied in patients with advanced solid tumors in a Phase 1 clinical trial.

Who makes PF-03732010?

PF-03732010 is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE.

What phase is PF-03732010 in?

PF-03732010 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed.

What clinical trials is PF-03732010 in?

PF-03732010 was studied in one completed Phase 1 clinical trial, NCT00557505, titled "A Study Of PF-03732010 In Patients With Advanced Solid Tumors." The trial enrolled 43 participants with neoplasms and was conducted in the United States, Australia, and South Korea.

Is PF-03732010 the same as any other drug?

No alternative names for PF-03732010 have been reported. It is identified solely by its compound code PF-03732010 in clinical trial records.