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

Sponsor

Pfizer (Industry)

Overall Status

Terminated

CT.gov ID

NCT00174369

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

2.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Nov 1, 2005

Actual Primary Completion Date :

Jun 1, 2007

Actual Study Completion Date :

Jun 1, 2007

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: PD0325901

15 mg BID

Drug: PD-0325901

15 mg BID

Outcome Measures

Primary Outcome Measures

To determine the activity of PD-0325901 in advanced non-small cell lung cancer [Duration of trial]

Secondary Outcome Measures

To determine the progression-free survival [Duration of trial]
To determine the duration of response [Duration of trial]
To determine the overall survival [Duration of trial]
To determine the safety profile of PD-0325901 [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 [Duration of trial]
To evaluate PD-0325901 population pharmacokinetics and explore its correlation with efficacy and safety parameters [Duration of trial]
To explore pharmacogenomic and cancer biomarkers (gene and/or protein expression profiling) relationships with cancer- and treatment-related outcomes [Duration of trial]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Greenbrae	California	United States	94904
2	Pfizer Investigational Site	La Jolla	California	United States	92093
3	Pfizer Investigational Site	LaJolla	California	United States	92037
4	Pfizer Investigational Site	San Diego	California	United States	92103
5	Pfizer Investigational Site	San Mateo	California	United States	94402
6	Pfizer Investigational Site	Tampa	Florida	United States	33612
7	Pfizer Investigational Site	Ann Arbor	Michigan	United States	48106-0995
8	Pfizer Investigational Site	Detroit	Michigan	United States	48201
9	Pfizer Investigational Site	Farmington Hills	Michigan	United States	48334
10	Pfizer Investigational Site	Coon Rapids	Minnesota	United States	55433
11	Pfizer Investigational Site	Fridley	Minnesota	United States	55432
12	Pfizer Investigational Site	Robbinsdale	Minnesota	United States	55422
13	Pfizer Investigational Site	New York	New York	United States	11725
14	Pfizer Investigational Site	Philadelphia	Pennsylvania	United States	19111

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

To obtain contact information for a study center near you, click here.

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00174369

Other Study ID Numbers:

A4581002

First Posted:

Sep 15, 2005

Last Update Posted:

Mar 17, 2009

Last Verified:

Feb 1, 2009

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Mar 17, 2009