Study Stopped
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MEK Inhibitor PD-325901 To Treat Advanced Breast Cancer, Colon Cancer, And Melanoma.
A Multicenter, Open-Label, Noncomparative Phase 1-2 Clinical And Pharmacokinetic Study Of Oral PD 0325901 In Patients With Advanced Cancer
1 other identifier
interventional
79
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2004
Longer than P75 for phase_1
17 active sites
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
Study Start
First participant enrolled
February 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 2, 2005
CompletedFirst Posted
Study publicly available on registry
September 7, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedSeptember 13, 2013
September 1, 2013
3.2 years
September 2, 2005
September 11, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Objective Response Rate, Safety.
duration of trial
Secondary Outcomes (1)
Time to progression, overall survival, patient reported outcomes.
duration of trial
Study Arms (1)
1
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
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 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (17)
Pfizer Investigational Site
Birmingham, Alabama, 35233-2115, United States
Pfizer Investigational Site
Birmingham, Alabama, 35233, United States
Pfizer Investigational Site
Birmingham, Alabama, 35294, United States
Pfizer Investigational Site
La Jolla, California, 92037, United States
Pfizer Investigational Site
La Jolla, California, 92093, United States
Pfizer Investigational Site
La Mesa, California, 91942, United States
Pfizer Investigational Site
Los Angeles, California, 90025, United States
Pfizer Investigational Site
San Diego, California, 92103, United States
Pfizer Investigational Site
San Diego, California, 92123, United States
Pfizer Investigational Site
Santa Monica, California, 90404, United States
Pfizer Investigational Site
Tampa, Florida, 33612, United States
Pfizer Investigational Site
Detroit, Michigan, 48201, United States
Pfizer Investigational Site
Detroit, Michigan, 48202, United States
Pfizer Investigational Site
Rochester, Minnesota, 55905, United States
Pfizer Investigational Site
New York, New York, 10021, United States
Pfizer Investigational Site
New York, New York, 10022, United States
Pfizer Investigational Site
Cleveland, Ohio, 44106, United States
Related Publications (1)
Boasberg PD, Redfern CH, Daniels GA, Bodkin D, Garrett CR, Ricart AD. Pilot study of PD-0325901 in previously treated patients with advanced melanoma, breast cancer, and colon cancer. Cancer Chemother Pharmacol. 2011 Aug;68(2):547-52. doi: 10.1007/s00280-011-1620-1. Epub 2011 Apr 24.
PMID: 21516509DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2005
First Posted
September 7, 2005
Study Start
February 1, 2004
Primary Completion
May 1, 2007
Study Completion
July 1, 2013
Last Updated
September 13, 2013
Record last verified: 2013-09