Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00147550
Status:
TERMINATED
Last Update Posted:
2013-09-13
First Post:
2005-09-02
Brief Title:
MEK Inhibitor PD-325901 To Treat Advanced Breast Cancer Colon Cancer And Melanoma
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A Multicenter Open-Label Noncomparative Phase 1-2 Clinical And Pharmacokinetic Study Of Oral PD 0325901 In Patients With Advanced Cancer
Status:
TERMINATED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
See termination reason in detailed description
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None