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TerminatedNCT00174369Updated Mar 17, 2009

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

A Phase 2 interventional study of PD-0325901 in Carcinoma, Non-Small-Cell Lung, sponsored by Pfizer. Terminated at 14 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-03-17.

Sponsored by Pfizer · Phase 2, Interventional, and Treatment

Why this study was terminated
Terminated \[See Detailed Description for Termination Reason.\]
Phase
Phase 2
Study type
Interventional
Enrollment
34
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Carcinoma, Non-Small-Cell Lung
03

In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's enrollment of 34 is below the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    PD0325901

    15 mg BID

    Drug: PD-0325901

Interventions

  • DrugPD-0325901

    15 mg BID

06

What researchers measure

Primary outcomes

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

    Time frame: Duration of trial

Secondary outcomes

  1. To determine the progression-free survival

    Time frame: Duration of trial

  2. To determine the duration of response

    Time frame: Duration of trial

  3. To determine the overall survival

    Time frame: Duration of trial

  4. To determine the safety profile of PD-0325901

    Time frame: Duration of trial

  5. 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

  6. To evaluate PD-0325901 population pharmacokinetics and explore its correlation with efficacy and safety parameters

    Time frame: Duration of trial

  7. To explore pharmacogenomic and cancer biomarkers (gene and/or protein expression profiling) relationships with cancer- and treatment-related outcomes

    Time frame: Duration of trial

07

Study locations

14 sites
  • Pfizer Investigational Site
    Greenbrae, California 94904, United States
  • Pfizer Investigational Site
    La Jolla, California 92093, United States
  • Pfizer Investigational Site
    LaJolla, California 92037, United States
  • Pfizer Investigational Site
    San Diego, California 92103, United States
  • Pfizer Investigational Site
    San Mateo, California 94402, United States
  • Pfizer Investigational Site
    Tampa, Florida 33612, United States
  • Pfizer Investigational Site
    Ann Arbor, Michigan 48106-0995, United States
  • Pfizer Investigational Site
    Detroit, Michigan 48201, United States
  • Pfizer Investigational Site
    Farmington Hills, Michigan 48334, United States
  • Pfizer Investigational Site
    Coon Rapids, Minnesota 55433, United States
  • Pfizer Investigational Site
    Fridley, Minnesota 55432, United States
  • Pfizer Investigational Site
    Robbinsdale, Minnesota 55422, United States
  • Pfizer Investigational Site
    New York, New York 11725, United States
  • Pfizer Investigational Site
    Philadelphia, Pennsylvania 19111, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00174369
Lead sponsor
Pfizer
First posted
Sep 15, 2005
Start date
Nov 2005
Primary completion
Jun 2007
Completion
Jun 2007
Last update
Mar 17, 2009

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.

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