CP-724,714 in Treating Patients With Metastatic Breast Cancer

NCT00055926

Last updated date
Study Location
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

- 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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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


- 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

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Pfizer Clinical Trials Contact Center

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[email protected]

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Advanced Information
Descriptive Information
Brief Title  ICMJE CP-724,714 in Treating Patients With Metastatic Breast Cancer
Official Title  ICMJE A Phase I Safety and Pharmacokinetic/Pharmacodynamic Study of CP-724, 714 In Patients With Metastatic HER2-Overexpressing Breast Cancer
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE Drug: CP-724,714
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 21, 2010)
9
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2005
Actual Primary Completion Date December 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00055926
Other Study ID Numbers  ICMJE CDR0000271533
UCLA-0209105
PFIZER-A4031001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jonsson Comprehensive Cancer Center
Study Sponsor  ICMJE Jonsson Comprehensive Cancer Center
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Carolyn Britten, MDJonsson Comprehensive Cancer Center
PRS Account Jonsson Comprehensive Cancer Center
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP