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

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00174369
• Other study ID #: A4581002
• Status: Terminated
• Phase: Phase 2
• First received: September 9, 2005
• Last updated: March 16, 2009
• Start date: November 2005
• Est. completion date: June 2007

Study information

• Verified date: February 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• PD-0325901
15 mg BID

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Ann Arbor	Michigan
United States	Pfizer Investigational Site	Coon Rapids	Minnesota
United States	Pfizer Investigational Site	Detroit	Michigan
United States	Pfizer Investigational Site	Farmington Hills	Michigan
United States	Pfizer Investigational Site	Fridley	Minnesota
United States	Pfizer Investigational Site	Greenbrae	California
United States	Pfizer Investigational Site	La Jolla	California
United States	Pfizer Investigational Site	LaJolla	California
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Robbinsdale	Minnesota
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	San Mateo	California
United States	Pfizer Investigational Site	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the activity of PD-0325901 in advanced non-small cell lung cancer		Duration of trial	No
Secondary	To determine the progression-free survival		Duration of trial	No
Secondary	To determine the duration of response		Duration of trial	No
Secondary	To determine the overall survival		Duration of trial	No
Secondary	To determine the safety profile of PD-0325901		Duration of trial	Yes
Secondary	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	No
Secondary	To evaluate PD-0325901 population pharmacokinetics and explore its correlation with efficacy and safety parameters		Duration of trial	No
Secondary	To explore pharmacogenomic and cancer biomarkers (gene and/or protein expression profiling) relationships with cancer- and treatment-related outcomes		Duration of trial	No

External Links

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