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MEK Inhibitor PD-325901 To Treat Advanced Breast Cancer, Colon Cancer, And Melanoma.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00147550
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : September 7, 2005
Last Update Posted : September 13, 2013
Information provided by (Responsible Party):

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 colon cancer, breast cancer, and melanoma. PD-325901 will be given by mouth as a pill twice a day, CT scans will be done and biopsies will be taken of a tumor before and once during treatment to measure the effects of the drug. Blood samples will be taken to measure the amount of drug in the blood.

Condition or disease Intervention/treatment Phase
Melanoma Colonic Neoplasms Breast Neoplasms Drug: PD-0325901 Phase 1 Phase 2

Detailed Description:
The study prematurely discontinued on March 15, 2007 due to a safety concern, specifically ocular and neurological toxicity presented at 10 mg twice-a-day and higher doses.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label, Noncomparative Phase 1-2 Clinical And Pharmacokinetic Study Of Oral PD 0325901 In Patients With Advanced Cancer
Study Start Date : February 2004
Actual Primary Completion Date : May 2007
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: 1 Drug: PD-0325901
Administered orally either once or twice a day; several dosing schedules evaluated; current dosing schedule is 5 days on-drug, 2-days off drug for 3 weeks in a 28-day cycle. Doses evaluated ranged from 1 mg once a day to 30 mg twice daily.

Primary Outcome Measures :
  1. Objective Response Rate, Safety. [ Time Frame: duration of trial ]

Secondary Outcome Measures :
  1. Time to progression, overall survival, patient reported outcomes. [ Time Frame: duration of trial ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age >= 18 years old
  • Tumor accessible for biopsy and willingness to undergo baseline and 1 post treatment biopsy
  • Biopsiable, histologically or cytologically confirmed metastatic or inoperable breast cancer, colon cancer, or melanoma. Prior treatment requirement : i) no more than 2 prior cytotoxic chemotherapy regimens for metastatic disease for patients with breast or colon cancers; ii) No prio cytotoxic therapy for patients with melanoma, or iii) measurable lesion (s) that have not been irradiated.
  • Adequate renal, liver, and bone marrow function, determined within 2 weeks prior to the first treatment, defined as the following: Serum creatinine <1.5 x ULN, total bilirubin <2 x ULN, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <3 x ULN (<5 x ULN for patients with liver involvement); absolute neutrophil count (ANC) >1500/ul; and platelet >100,000/ul
  • Hemoglobin >9.0 g/dL. Treatment with transfusions or erythropoietin to elevate the hemoglobin level for eligibility purposes is not permitted. Patients must have discontinued erythropoietin at least 2 weeks prior to the first dose of study medication
  • Serum calcium <1 x ULN and phosphorus <1 x ULN
  • Patients having reproductive potential must use adequate method of birth control. Patients may not be pregnant or breastfeeding.
  • ECOG Status of 0,1, or 2.
  • Must be able to swallow intact study medication and have no gastrointestinal disorders that may affect absorption of the drug
  • Must be able to follow instructions or protocol specified procedures, or have a daily care giver who will be responsible for administering study medication.
  • Must be able to give written informed consent.

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 any cancer other than the present condition (except nonmelanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission and off all therapy for that disease for a minimum of 3 years
  • No untreated brain metastases.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00147550

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United States, Alabama
Pfizer Investigational Site
Birmingham, Alabama, United States, 35233-2115
Pfizer Investigational Site
Birmingham, Alabama, United States, 35233
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294
United States, California
Pfizer Investigational Site
La Jolla, California, United States, 92037
Pfizer Investigational Site
La Jolla, California, United States, 92093
Pfizer Investigational Site
La Mesa, California, United States, 91942
Pfizer Investigational Site
Los Angeles, California, United States, 90025
Pfizer Investigational Site
San Diego, California, United States, 92103
Pfizer Investigational Site
San Diego, California, United States, 92123
Pfizer Investigational Site
Santa Monica, California, United States, 90404
United States, Florida
Pfizer Investigational Site
Tampa, Florida, United States, 33612
United States, Michigan
Pfizer Investigational Site
Detroit, Michigan, United States, 48201
Pfizer Investigational Site
Detroit, Michigan, United States, 48202
United States, Minnesota
Pfizer Investigational Site
Rochester, Minnesota, United States, 55905
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10021
Pfizer Investigational Site
New York, New York, United States, 10022
United States, Ohio
Pfizer Investigational Site
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Pfizer Identifier: NCT00147550    
Other Study ID Numbers: A4581001
First Posted: September 7, 2005    Key Record Dates
Last Update Posted: September 13, 2013
Last Verified: September 2013
Additional relevant MeSH terms:
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Breast Neoplasms
Colonic Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms by Site
Breast Diseases
Skin Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases