MEK Inhibitor PD-325901 To Treat Advanced Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00174369
Recruitment Status : Terminated (Terminated [See Detailed Description for Termination Reason.])
First Posted : September 15, 2005
Last Update Posted : March 17, 2009
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Brief Summary:
MEK is a critical member of the MAPK pathway involved in growth and survival of cancer cells. PD-325901 is a new drug designed to block this pathway and kill cancer cells. The purpose of this study is to study the effectiveness of PD-325901 in patients with non-small cell lung cancer. PD-325901 will be given by mouth as a pill twice a day, CT scans will be done and biopsies of a tumor and a blood sample will be taken before treatment to examine the how genes affect tumor response to the study medication. Blood samples will be taken to measure the amount of drug in the blood.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: PD-0325901 Phase 2

Detailed Description:
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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study Of The MEK Inhibitor PD-0325901 In Patients With Advanced Non-Small Cell Lung Cancer
Study Start Date : November 2005
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: PD0325901
15 mg BID
Drug: PD-0325901
15 mg BID

Primary Outcome Measures :
  1. To determine the activity of PD-0325901 in advanced non-small cell lung cancer [ Time Frame: Duration of trial ]

Secondary Outcome Measures :
  1. To determine the progression-free survival [ Time Frame: Duration of trial ]
  2. To determine the duration of response [ Time Frame: Duration of trial ]
  3. To determine the overall survival [ Time Frame: Duration of trial ]
  4. To determine the safety profile of PD-0325901 [ Time Frame: Duration of trial ]
  5. To explore pharmacogenomic and cancer biomarkers (gene and/or protein expression profiling) relationships with cancer- and treatment-related outcomes duration of response [ Time Frame: Duration of trial ]
  6. To evaluate PD-0325901 population pharmacokinetics and explore its correlation with efficacy and safety parameters [ Time Frame: Duration of trial ]
  7. To explore pharmacogenomic and cancer biomarkers (gene and/or protein expression profiling) relationships with cancer- and treatment-related outcomes [ Time Frame: Duration of trial ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00174369

United States, California
Pfizer Investigational Site
Greenbrae, California, United States, 94904
Pfizer Investigational Site
La Jolla, California, United States, 92093
Pfizer Investigational Site
LaJolla, California, United States, 92037
Pfizer Investigational Site
San Diego, California, United States, 92103
Pfizer Investigational Site
San Mateo, California, United States, 94402
United States, Florida
Pfizer Investigational Site
Tampa, Florida, United States, 33612
United States, Michigan
Pfizer Investigational Site
Ann Arbor, Michigan, United States, 48106-0995
Pfizer Investigational Site
Detroit, Michigan, United States, 48201
Pfizer Investigational Site
Farmington Hills, Michigan, United States, 48334
United States, Minnesota
Pfizer Investigational Site
Coon Rapids, Minnesota, United States, 55433
Pfizer Investigational Site
Fridley, Minnesota, United States, 55432
Pfizer Investigational Site
Robbinsdale, Minnesota, United States, 55422
United States, New York
Pfizer Investigational Site
New York, New York, United States, 11725
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19111
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00174369     History of Changes
Other Study ID Numbers: A4581002
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: March 17, 2009
Last Verified: February 2009

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases