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Phase 2 Study Of The MEK Inhibitor PD-0325901 In Patients With Advanced Non-Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Carcinoma, Non-Small-Cell Lung

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Trial Information

Phase 2 Study Of The MEK Inhibitor PD-0325901 In Patients With Advanced Non-Small Cell Lung Cancer

This study was terminated prematurely on 23 March 2007 due to safety issues (ocular and
neurological toxicity observed in another PD-0325901 study, A4581001) as well as lack of
objective responses

Inclusion Criteria:

- Histologically documented non-small cell lung cancer with metastases (Stage IV or
recurrent disease) or locally advanced (Stage IIIB) with malignant pleural effusion
with no expectation of further effects of prior anticancer therapy, and resolution of
all acute toxic effects

- Adequate renal, liver, and bone marrow function, determined within 2 weeks prior to
the first treatment and an ECOG status of <=1.

- Must have evidence of progression of disease within 6 months of most recent prior
systemic anticancer therapy.

Exclusion Criteria:

- No parathyroid disorder or history of malignancy associated hypercalcemia

- No ongoing radiation therapy or radio-cytotoxic therapy within prior 4 weeks; No
immunotherapy, biologic therapy, hormonal, or molecular targeted therapy within prior
2 weeks

- No concurrent serious infection or life-threatening illness (unrelated to tumor)

- No history of a malignancy (other tha non-small cell lung cancer) except those
treated with curative intent for skin cancer (other than melanoma) or in situ breast
or cervical cancer or those treated with curative intent for any other cancer with no
evidence of disease for 5 years.

- No active seizure disorders or untreated brain metastases.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the activity of PD-0325901 in advanced non-small cell lung cancer

Outcome Time Frame:

Duration of trial

Safety Issue:


Principal Investigator

Pfizer Call Center

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

November 2005

Completion Date:

June 2007

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Pfizer Investigational Site Blendora, California  91740
Pfizer Investigational Site Detroit, Michigan  48201
Pfizer Investigational Site Rochester, Minnesota  55905
Pfizer Investigational Site Bronx, New York  10461
Pfizer Investigational Site Clearwater, Florida  33761
Pfizer Investigational Site Kingston, Pennsylvania  18704-5535