NCT00174369

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2005

Geographic Reach
1 country

14 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

March 17, 2009

Status Verified

February 1, 2009

Enrollment Period

1.6 years

First QC Date

September 9, 2005

Last Update Submit

March 16, 2009

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

  • To determine the activity of PD-0325901 in advanced non-small cell lung cancer

    Duration of trial

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (1)

PD0325901

EXPERIMENTAL

15 mg BID

Drug: PD-0325901

Interventions

PD-0325901DRUG

15 mg BID

PD0325901

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Pfizer Investigational Site

Greenbrae, California, 94904, United States

Location

Pfizer Investigational Site

La Jolla, California, 92037, United States

Location

Pfizer Investigational Site

La Jolla, California, 92093, United States

Location

Pfizer Investigational Site

San Diego, California, 92103, United States

Location

Pfizer Investigational Site

San Mateo, California, 94402, United States

Location

Pfizer Investigational Site

Tampa, Florida, 33612, United States

Location

Pfizer Investigational Site

Ann Arbor, Michigan, 48106-0995, United States

Location

Pfizer Investigational Site

Detroit, Michigan, 48201, United States

Location

Pfizer Investigational Site

Farmington Hills, Michigan, 48334, United States

Location

Pfizer Investigational Site

Coon Rapids, Minnesota, 55433, United States

Location

Pfizer Investigational Site

Fridley, Minnesota, 55432, United States

Location

Pfizer Investigational Site

Robbinsdale, Minnesota, 55422, United States

Location

Pfizer Investigational Site

New York, New York, 11725, United States

Location

Pfizer Investigational Site

Philadelphia, Pennsylvania, 19111, United States

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

mirdametinib

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

November 1, 2005

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

March 17, 2009

Record last verified: 2009-02

Locations

US(14)