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

This study has been terminated.
(Terminated [See Detailed Description for Termination Reason.])
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00174369
First received: September 9, 2005
Last updated: March 16, 2009
Last verified: February 2009
  Purpose

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 Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: PD-0325901
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • To determine the activity of PD-0325901 in advanced non-small cell lung cancer [ Time Frame: Duration of trial ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the progression-free survival [ Time Frame: Duration of trial ] [ Designated as safety issue: No ]
  • To determine the duration of response [ Time Frame: Duration of trial ] [ Designated as safety issue: No ]
  • To determine the overall survival [ Time Frame: Duration of trial ] [ Designated as safety issue: No ]
  • To determine the safety profile of PD-0325901 [ Time Frame: Duration of trial ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • To evaluate PD-0325901 population pharmacokinetics and explore its correlation with efficacy and safety parameters [ Time Frame: Duration of trial ] [ Designated as safety issue: No ]
  • To explore pharmacogenomic and cancer biomarkers (gene and/or protein expression profiling) relationships with cancer- and treatment-related outcomes [ Time Frame: Duration of trial ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: November 2005
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PD0325901
15 mg BID
Drug: PD-0325901
15 mg BID

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00174369

Locations
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
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00174369     History of Changes
Other Study ID Numbers: A4581002
Study First Received: September 9, 2005
Last Updated: March 16, 2009
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 15, 2014