Status:
TERMINATED
MEK Inhibitor PD-325901 To Treat Advanced Non-Small Cell Lung Cancer
Lead Sponsor:
Pfizer
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00174369
Start Date
November 1 2005
End Date
June 1 2007
Last Update
March 17 2009
Active Locations (14)
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1
Pfizer Investigational Site
Greenbrae, California, United States, 94904
2
Pfizer Investigational Site
La Jolla, California, United States, 92037
3
Pfizer Investigational Site
La Jolla, California, United States, 92093
4
Pfizer Investigational Site
San Diego, California, United States, 92103