Breast CancerPhase 1NCT00055926
CP-724,714 in Treating Patients With Metastatic Breast Cancer
A Phase 1 study testing CP-724,714 in people with Breast Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- CP-724,714
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to May 2005
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 18 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
- AST/ALT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
- Renal
- Creatinine no greater than 1.5 times ULN OR
- Creatinine clearance at least 60 mL/min
- Cardiovascular
- 12-lead ECG with normal tracing
- history of cardiovascular disease (i.e., ischemic heart disease, arrhythmia, or congestive heart failure) unless asymptomatic for the past year with no requirement for antiarrhythmics or a clinically significant medical management change
- Gastrointestinal
- Able to take oral medication* Negative pregnancy test
- Fertile patients must use effective contraception
- At least 4 weeks since prior trastuzumab (Herceptin)
- At least 4 weeks since other prior biologic therapy or immunotherapy
- At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas)
- At least 6 months since prior doxorubicin or doxorubicin equivalents without any prior or developing signs or symptoms of cardiomyopathy
- No cumulative doses of more than 300 mg/m^2
- At least 2 weeks since prior hormonal therapy for the primary disease
- Concurrent hormone replacement therapy or luteinizing hormone-releasing hormone agonists allowed
- At least 4 weeks since prior radiotherapy
- At least 3 weeks since prior major surgery (2 weeks for minor surgery)
- Recovered from prior therapy
- At least 4 weeks since prior investigational treatment
- Coumarin or heparin derivatives allowed for the prevention of deep vein thrombosis or port patency
Who cannot join
- 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
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- 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
- concurrent immunotherapy
- more than 1 prior anthracycline- or anthracenedione-containing regimen (except with approval of the sponsor)
- prior high-dose chemotherapy with hematopoietic stem cell transplantation
- concurrent anticancer chemotherapy
- No concurrent anticancer hormonal therapy, including tamoxifen
- prior radiotherapy to the only disease site that would be assessed for response
- concurrent radiotherapy
- prior partial or complete gastrectomy
- concurrent antiarrhythmics
- concurrent antacids
- concurrent anticoagulant at therapeutic doses
- other concurrent experimental anticancer medications for breast cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
About this study
Official title: A Phase I Safety and Pharmacokinetic/Pharmacodynamic Study of CP-724, 714 In Patients With Metastatic HER2-Overexpressing Breast Cancer
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.
Read the detailed description
OBJECTIVES:
- Determine the safety and tolerability of CP-724,714 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-724,714 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-724,714 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.
- Conditions
- Breast Cancer
- Being tested
- CP-724,714
- Keywords
- recurrent breast cancer, stage IV breast cancer, male breast cancer
- Medical subject headings
- Breast Neoplasms, Breast Neoplasms, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP-724,714Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2003 (estimated)
- Study startJan 2003
- Primary completionDec 2004
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Carolyn Britten, MD, Principal investigator, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00055926
- Sponsor's protocol ID
- CDR0000271533
- Other IDs
- UCLA-0209105, PFIZER-A4031001
- Status last verified
- Aug 2012
- First submitted
- 6 Mar 2003
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Safety and Pharmacokinetic/Pharmacodynamic Study of CP-724, 714 In Patients With Metastatic HER2-Overexpressing Breast Cancer
- ClinicalTrials.gov ID
- NCT00055926
- Acronym / sponsor ID
- CDR0000271533
- Conditions
- Breast Cancer
- Keywords
- recurrent breast cancer, stage IV breast cancer, male breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jan 2003
- Primary completion
- Dec 2004 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 7 Mar 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
- Determine the safety and tolerability of CP-724,714 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-724,714 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-724,714 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 design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (37 listed)
- 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
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CP-724,714 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolyn Britten, MD principal investigator
Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CP-724,714 in people with Breast Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 37 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2020.