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

Last updated on November 8, 2019

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Study Location
Pfizer Investigational Site
Greenbrae, California, 94904 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-Small-Cell Lung Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

- Must have evidence of progression of disease within 6 months of most recent prior
systemic anticancer therapy.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00174369
Pfizer
Terminated
MEK Inhibitor PD-325901 To Treat Advanced Non-Small Cell Lung Cancer

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Descriptive Information
Brief Title  ICMJE MEK Inhibitor PD-325901 To Treat Advanced Non-Small Cell Lung Cancer
Official Title  ICMJE Phase 2 Study Of The MEK Inhibitor PD-0325901 In Patients With Advanced Non-Small Cell Lung Cancer
Brief SummaryMEK 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.
Detailed DescriptionThis 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small-Cell Lung
Intervention  ICMJE Drug: PD-0325901
15 mg BID
Study Arms  ICMJE Experimental: PD0325901
15 mg BID
Intervention: Drug: PD-0325901
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 9, 2009)
34
Original Enrollment  ICMJE
 (submitted: September 9, 2005)
60
Actual Study Completion Date  ICMJE June 2007
Actual Primary Completion DateJune 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00174369
Other Study ID Numbers  ICMJE A4581002
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateFebruary 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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