Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00055926
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2003-03-06
Brief Title:
CP-724714 in Treating Patients With Metastatic Breast Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
A Phase I Safety and PharmacokineticPharmacodynamic Study of CP-724 714 In Patients With Metastatic HER2-Overexpressing Breast Cancer
Status:
COMPLETED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE CP-724714 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth
PURPOSE Phase I trial to study the effectiveness of CP-724714 in treating patients who have metastatic HER2-overexpressing breast cancer
PURPOSE Phase I trial to study the effectiveness of CP-724714 in treating patients who have metastatic HER2-overexpressing breast cancer
Detailed Description:
OBJECTIVES
Determine the safety and tolerability of CP-724714 in patients with metastatic HER2-overexpressing breast cancer
Determine the maximum tolerated dose of this drug in these patients
Determine preliminarily any antitumor activity of this drug in these patients
Determine the pharmacokinetics of this drug in these patients
Determine the relationship of drug-related adverse events to pharmacokinetic exposure parameters in these patients
Determine the relationship of changes in serum HER2 extracellular domain and HER2 receptor tyrosine kinase phosphorylation to pharmacokinetic exposure parameters and clinical outcome in patients treated with this drug
OUTLINE This is an open-label dose-escalation multicenter study
Patients receive oral CP-724714 on days 1 and 3-21 during course 1 and then daily during subsequent courses Courses repeat every 3 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of CP-724714 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed for at least 30 days
PROJECTED ACCRUAL A total of 3-20 patients will be accrued for this study within 6 months
Determine the safety and tolerability of CP-724714 in patients with metastatic HER2-overexpressing breast cancer
Determine the maximum tolerated dose of this drug in these patients
Determine preliminarily any antitumor activity of this drug in these patients
Determine the pharmacokinetics of this drug in these patients
Determine the relationship of drug-related adverse events to pharmacokinetic exposure parameters in these patients
Determine the relationship of changes in serum HER2 extracellular domain and HER2 receptor tyrosine kinase phosphorylation to pharmacokinetic exposure parameters and clinical outcome in patients treated with this drug
OUTLINE This is an open-label dose-escalation multicenter study
Patients receive oral CP-724714 on days 1 and 3-21 during course 1 and then daily during subsequent courses Courses repeat every 3 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of CP-724714 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed for at least 30 days
PROJECTED ACCRUAL A total of 3-20 patients will be accrued for this study within 6 months
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PFIZER-A4031001 | None | None | None |
| UCLA-0209105 | None | None | None |