Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00102895
Status:
TERMINATED
Last Update Posted:
2010-08-27
First Post:
2005-02-03
Brief Title:
A Research Study of CP-724714 in Patients With HER2 Overexpressing Metastatic Breast Cancer
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
An Open-Label Multi-Center Phase 2 Study Of Cp 724714 In Patients With Her2 Overexpressing Metastatic Breast Cancer That Has Progressed After Chemotherapy For Metastatic Disease And Is Previously Untreated With A Her2 Inhibitor
Status:
TERMINATED
Status Verified Date:
2010-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
See Detailed Description
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main purpose of this research study is to see if the study drug named CP-724714 can help in the treatment of certain breast cancers that have spread to other locations in the body Other goals of this study are to measure how long it may take for the cancer to get worse progress to see if there are any side effects from the study drug to check the amount of study drug in the blood at different times and to check to see if there is any relationship between certain blood tests and how patients may respond to the study drug
About 25 subjects at 4 sites hospitals and clinics in Bulgaria and Russia will be involved in the trial Participation in this study can last up to 48 weeks depending on the participants toleration of the study drug and the response of her tumors to the study drug All participants will receive CP-724714 at a daily dose of 250 mg 4 pills every 12 hours
About 25 subjects at 4 sites hospitals and clinics in Bulgaria and Russia will be involved in the trial Participation in this study can last up to 48 weeks depending on the participants toleration of the study drug and the response of her tumors to the study drug All participants will receive CP-724714 at a daily dose of 250 mg 4 pills every 12 hours
Detailed Description:
Pfizer decided to terminate clinical protocol A4031003 on October 7 2005 due to the excessive number of patients with grade 3 liver function test elevations and lack of efficacy
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