CP-724,714 in Treating Patients With Metastatic Breast Cancer
A Phase I Safety and Pharmacokinetic/Pharmacodynamic Study of CP-724, 714 In Patients With Metastatic HER2-Overexpressing Breast Cancer
3 other identifiers
interventional
9
1 country
1
Brief Summary
RATIONALE: CP-724,714 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-724,714 in treating patients who have metastatic HER2-overexpressing breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 breast-cancer
Started Jan 2003
1 active site
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
January 1, 2003
CompletedFirst Submitted
Initial submission to the registry
March 6, 2003
CompletedFirst Posted
Study publicly available on registry
March 7, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2005
CompletedAugust 3, 2020
August 1, 2012
1.9 years
March 6, 2003
July 30, 2020
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed HER2-overexpressing breast cancer
- Prior or newly documented HER2 amplification by fluorescence in situ hybridization (FISH)
- Progressive metastatic disease
- Must have received at least one prior chemotherapy regimen for metastatic breast cancer
- At least 1 measurable or evaluable lesion
- At least 1 lesion accessible for 2 separate core biopsies for pharmacodynamic evaluation
- and over
- Male or female
- ECOG 0-1
- Life expectancy, More than 3 months
- Hematopoietic
- Absolute neutrophil count at least 1,500/mm\^3\*
- Platelet count at least 100,000/mm\^3\* NOTE: \*Without hematopoietic growth factors or transfusions
- Hepatic
- Bilirubin no greater than 1.5 mg/dL
- +22 more criteria
You may not qualify if:
- known or clinically suspected brain metastases or leptomeningeal disease
- symptomatic edema or third-space fluid (e.g., ascites or pleural effusions)
- known hepatitis B or C infection
- significant ECG changes that require medical intervention
- QTc interval less than 460 msec
- No history of torsade or other symptomatic QTc abnormality
- LVEF greater than 50% by MUGA
- gastrointestinal abnormality that would require medications (including all antacids)
- persistent symptoms of an esophageal or digestive disorder
- pregnant or nursing
- known HIV infection
- active infection
- concurrent uncontrolled systemic disorders or laboratory abnormalities that would preclude study drug safety evaluation
- mental disorder that would preclude study compliance or ability to give informed consent
- No more than 2 prior trastuzumab-based regimens for advanced disease
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jonsson Comprehensive Cancer Centerlead
- Pfizercollaborator
Study Sites (1)
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carolyn Britten, MD
Jonsson Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2003
First Posted
March 7, 2003
Study Start
January 1, 2003
Primary Completion
December 1, 2004
Study Completion
May 1, 2005
Last Updated
August 3, 2020
Record last verified: 2012-08