- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00174369
MEK Inhibitor PD-325901 To Treat Advanced Non-Small Cell Lung Cancer
March 16, 2009 updated by: Pfizer
Phase 2 Study Of The MEK Inhibitor PD-0325901 In Patients With Advanced Non-Small Cell Lung Cancer
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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
Enrollment (Actual)
34
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Greenbrae, California, United States, 94904
- Pfizer Investigational Site
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La Jolla, California, United States, 92093
- Pfizer Investigational Site
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LaJolla, California, United States, 92037
- Pfizer Investigational Site
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San Diego, California, United States, 92103
- Pfizer Investigational Site
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San Mateo, California, United States, 94402
- Pfizer Investigational Site
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Florida
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Tampa, Florida, United States, 33612
- Pfizer Investigational Site
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Michigan
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Ann Arbor, Michigan, United States, 48106-0995
- Pfizer Investigational Site
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Detroit, Michigan, United States, 48201
- Pfizer Investigational Site
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Farmington Hills, Michigan, United States, 48334
- Pfizer Investigational Site
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Minnesota
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Coon Rapids, Minnesota, United States, 55433
- Pfizer Investigational Site
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Fridley, Minnesota, United States, 55432
- Pfizer Investigational Site
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Robbinsdale, Minnesota, United States, 55422
- Pfizer Investigational Site
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New York
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New York, New York, United States, 11725
- Pfizer Investigational Site
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19111
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PD0325901
15 mg BID
|
15 mg BID
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the activity of PD-0325901 in advanced non-small cell lung cancer
Time Frame: Duration of trial
|
Duration of trial
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the progression-free survival
Time Frame: Duration of trial
|
Duration of trial
|
To determine the duration of response
Time Frame: Duration of trial
|
Duration of trial
|
To determine the overall survival
Time Frame: Duration of trial
|
Duration of trial
|
To determine the safety profile of PD-0325901
Time Frame: Duration of trial
|
Duration of trial
|
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
|
Duration of trial
|
To evaluate PD-0325901 population pharmacokinetics and explore its correlation with efficacy and safety parameters
Time Frame: Duration of trial
|
Duration of trial
|
To explore pharmacogenomic and cancer biomarkers (gene and/or protein expression profiling) relationships with cancer- and treatment-related outcomes
Time Frame: Duration of trial
|
Duration of trial
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2005
Primary Completion (Actual)
June 1, 2007
Study Completion (Actual)
June 1, 2007
Study Registration Dates
First Submitted
September 9, 2005
First Submitted That Met QC Criteria
September 9, 2005
First Posted (Estimate)
September 15, 2005
Study Record Updates
Last Update Posted (Estimate)
March 17, 2009
Last Update Submitted That Met QC Criteria
March 16, 2009
Last Verified
February 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A4581002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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