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PF-00337210

Phase 1

Neoplasm | Small molecule | Oncology |Pfizer, Inc.|Trials Updated: Mar 19, 2013

PF-00337210 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Apr 2010

PF-00337210 target and mechanism

Molecular targetKDR
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment46

FDA Designations

No designations recorded

PF-00337210 clinical trials

PF-00337210 · 1 trial · 1 indication

Phase 1 1
NCT01105533A Dose Finding Study Of A New Medication, PF-00337210 That Will Possibly Decrease Blood Supply To TumorsNeoplasm
COMPLETED46 Analytics
PHASE1COMPLETED
A Dose Finding Study Of A New Medication, PF-00337210 That Will Possibly Decrease Blood Supply To Tumors
NeoplasmUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Dose-limiting Toxicities (DLTs)
Baseline up to Day 28

DLTs included events occurring in Cycle 1: blood pressure of 180/110 millimeters of mercury (mmHg) or higher for 3 readings over 3 hours regardless of use of anti-hypertensive drugs or greater than (\>) 160/100 mmHg for 3 readings over 3 days on maximum anti-hypertensive drugs; afebrile Grade 4 neutropenia for greater than or equal to (\>=) 7 days or \>=Grade 3 neutropenia associated with fever (1 reading of oral temperature \>38.5 degree Celsius \[degree C\] or 3 readings of oral temperature \>38.0 degree C in 24-hour period); Grade 4 thrombocytopenia; hemoptysis of \>1/2 teaspoon of bright red blood per day; proteinuria of \>=2 grams/24 hours; inability to resume PF-00337210 dosing at current dose level within 14 days of stopping due to treatment-related toxicity; \>=Grade 3 nonhematological toxicities (except alopecia and blood pressure/hypertension); Grade 3 nonhematological toxicities that could be controlled to Grade 2 or less with appropriate treatment were not considered dose limiting.

Maximum Tolerated Dose (MTD)
Day 28

MTD: dose level at which no more than 1 of 6 participants experienced DLT during Cycle 1. DLTs: blood pressure of 180/110 mmHg or higher for 3 readings over 3 hours regardless of use of anti-hypertensive drugs or \>160/100 mmHg for 3 readings over 3 days on maximum anti-hypertensive drugs; afebrile Grade 4 neutropenia \>=7 days or \>= Grade 3 neutropenia associated with fever (1 reading of oral temperature \>38.5 degree C or 3 readings of oral temperature \>38.0 degree C in 24-hour period); Grade 4 thrombocytopenia; hemoptysis of \>1/2 teaspoon of bright red blood per day; proteinuria of \>=2 grams/24 hours; inability to resume PF-00337210 dosing at current dose level within 14 days of stopping due to treatment-related toxicity; \>=Grade 3 nonhematological toxicities (except alopecia and blood pressure/hypertension); Grade 3 nonhematological toxicities that could be controlled to Grade 2 or less with appropriate treatment were not considered dose limiting.

Maximum Administered Dose (MAD)
Day 28

MAD: dose level at which 2 or more out of 6 participants experienced DLT during Cycle 1. DLTs: blood pressure of 180/110 mmHg or higher for 3 readings over 3 hours regardless of use of anti-hypertensive drugs or \>160/100 mmHg for 3 readings over 3 days on maximum anti-hypertensive drugs; afebrile Grade 4 neutropenia \>=7 days or \>= Grade 3 neutropenia associated with fever (1 reading of oral temperature \>38.5 degree C or 3 readings of oral temperature \>38.0 degree C in 24-hour period); Grade 4 thrombocytopenia; hemoptysis of \>1/2 teaspoon of bright red blood per day; proteinuria of \>=2 grams/24 hours; inability to resume PF-00337210 dosing at current dose level within 14 days of stopping due to treatment-related toxicity; \>=Grade 3 nonhematological toxicities (except alopecia and blood pressure/hypertension); Grade 3 nonhematological toxicities that could be controlled to Grade 2 or less with appropriate treatment were not considered dose limiting.

Recommended Phase-2 Dose (RP2D)
Day 28

RP2D was determined based on the safety profile and pharmacodynamic findings. The twice daily dosing was preferred over once daily dosing for RP2D, as per investigator's discretion, due to more consistent changes in pharmacodynamic markers and greater clinical benefit observed in twice daily dosing.

Secondary Endpoints

Maximum Observed Plasma Concentration (Cmax)
Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hours(hrs) post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57
Plasma Decay Half-Life (t1/2)
Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hrs post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)]
Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hrs post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTAL -
Cohort 2EXPERIMENTAL -
Cohort 3EXPERIMENTAL -
Cohort 4EXPERIMENTAL -
Cohort 5EXPERIMENTAL -
Cohort 6EXPERIMENTAL -
Cohort 7EXPERIMENTAL -
Cohort 8EXPERIMENTAL -
Cohort 9EXPERIMENTAL -
Cohort 10EXPERIMENTAL -

Interventions

NameTypeDescription
PF-00337210DRUG0.67mg Capsule Once Daily (Accelerated Dose Escalation) Continuous
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Histologically or cytologically confirmed advanced solid tumors un-responsive to currently available therapies or for which there is no standard therapy. * At least 1 measurable disease site as defined by Response Evaluation Criterion in Solid Tumors \[RECIST\]. * Adequate bon...

Countries:United States
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Frequently asked questions about PF-00337210

What is PF-00337210?

PF-00337210 is an investigational small molecule developed by Pfizer, Inc. (ticker PFE) for the treatment of neoplasm, the medical term for tumors. It is in Phase 1 clinical development in the oncology therapeutic area. It has not been approved by the FDA and remains an experimental agent studied in research settings.

What does PF-00337210 target?

PF-00337210 targets KDR, also known as vascular endothelial growth factor receptor 2. It is an inhibitor of this target. Because KDR signaling drives the growth of blood vessels that feed tumors, inhibiting it is intended to possibly decrease blood supply to tumors, which is the rationale described in its clinical study.

Who makes PF-00337210?

Pfizer, Inc. is the developer of PF-00337210. Pfizer trades on the New York Stock Exchange under the ticker symbol PFE. The company sponsored the Phase 1 dose finding study of the compound in patients with neoplasm.

What phase is PF-00337210 in?

PF-00337210 is in Phase 1 clinical development. It is an investigational drug and is not FDA approved. One Phase 1 trial has been completed, and no trials are currently listed as active. The program enrolled 46 participants in total.

What clinical trials is PF-00337210 in?

PF-00337210 has been studied in one clinical trial, NCT01105533, titled A Dose Finding Study Of A New Medication, PF-00337210 That Will Possibly Decrease Blood Supply To Tumors. That Phase 1 trial is completed and enrolled 46 participants with neoplasm in the United States. It was controlled, open label, and not randomized.