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PF00299804

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

Clinical trial landscape

PF00299804 · 1 trial · 1 indication

Phase 1 1
NCT01034748A Radiolabeled Mass Balance Study Of [14C]PF-00299804 In Healthy Male VolunteersCarcinoma, Non-Small-Cell Lung
COMPLETED6 Analytics
PHASE1COMPLETED
A Radiolabeled Mass Balance Study Of [14C]PF-00299804 In Healthy Male Volunteers
Carcinoma, Non-Small-Cell Lung
NCT010347486
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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 to 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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Frequently asked questions about PF00299804

What is PF-00299804 used for?

PF-00299804 is an investigational small molecule being studied for the treatment of advanced non-small cell lung cancer, head and neck neoplasms, and other solid tumors. It has been evaluated in patients with non-small cell lung cancer who have failed prior chemotherapy and erlotinib treatment.

Who makes PF-00299804?

PF-00299804 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is an oral small molecule in the oncology therapeutic area.

What phase is PF-00299804 in?

PF-00299804 is an investigational drug that has completed Phase 1 and Phase 2 clinical trials. It is not FDA approved and remains in clinical development. All four completed trials were uncontrolled, non-randomized studies.

What clinical trials is PF-00299804 in?

PF-00299804 has been studied in four completed clinical trials. NCT00548093 and NCT00553254 were Phase 2 trials in advanced non-small cell lung cancer. NCT00728390 was a Phase 1 combination study with CP-751,871. NCT00728468 was a Phase 1 drug interaction study with dextromethorphan.

What is the mechanism of action of PF-00299804?

PF-00299804 is a small molecule developed by Pfizer for oncology indications. Its specific molecular target has not been disclosed in the available clinical trial information. The drug has been evaluated as a single agent and in combination with other therapies for advanced solid tumors.