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Safety And Efficacy Study Of The Combination Of CpG 7909 And Herceptin In Patients With Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT00031278
Recruitment Status : Completed
First Posted : March 1, 2002
Last Update Posted : May 30, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE February 28, 2002
First Posted Date  ICMJE March 1, 2002
Last Update Posted Date May 30, 2011
Study Start Date  ICMJE October 2001
Actual Primary Completion Date June 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2008)
  • Phase I: To evaluate the safety, tolerability and and MTD of several dose levels of CPG 7909 of CPG 7909 in combination with the standard Herceptin® treatment in patients with metastatic breast cancer
  • Phase II: Evaluate tumor response and safety of CPG 7909 in combination with Herceptin® in patients with metastatic breast cancer
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2008)
  • Phase I: To evaluate tumor response, duration of response, time to disease progression, and survival time
  • Phase II: To evaluate duration of response, time to disease progression, and survival time
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety And Efficacy Study Of The Combination Of CpG 7909 And Herceptin In Patients With Metastatic Breast Cancer
Official Title  ICMJE A Phase I/II Open Label, Multi-Center Study For The Evaluation Of The Combination Of CpG 7909 And Herceptin® In Patients With Metastatic Breast Cancer
Brief Summary

The purpose of this study is to determine if the combination of CPG 7909 and Herceptin is safe and effective in the treatment of metastatic breast cancer.

RATIONALE: There is preclinical data that supports the hypothesis that CPG 7909 may potentiate the action of Herceptin. This Phase I/II study is designed to evaluate the safety and efficacy of the combination treatment of CPG 7909 and Herceptin in patients with metastatic breast cancer who have previously been treated with Herceptin and chemotherapy.

SCHEDULE: Patients will receive CPG 7909 weekly for up to six months.

Detailed Description Phase II part of study not initiated because the development plan modified the route of administration to subcutaneous injection.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Metastatic Breast
Intervention  ICMJE
  • Drug: CPG 7909
    Each 0.01 mg/kg CPG 7909 treatment will consist of a monitored 2-hour infusion given once weekly until disease progression or a maximum of 24 weeks.
    Other Name: PF-3512676, ProMune
  • Drug: Herceptin®
    Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert
    Other Name: trastuzumab
  • Drug: CPG 7909
    Each 0.04 mg/kg CPG 7909 treatment will consist of a monitored 2-hour infusion given once weekly until disease progression or a maximum of 24 weeks.
    Other Name: PF-3512676, ProMune
  • Drug: CPG 7909
    Each 0.16 mg/kg CPG 7909 treatment will consist of a monitored 2-hour infusion given once weekly until disease progression or a maximum of 24 weeks.
    Other Name: PF-3512676, ProMune
  • Drug: CPG 7909
    Each 0.32 mg/kg CPG 7909 treatment will consist of a monitored 2-hour infusion given once weekly until disease progression or a maximum of 24 weeks.
    Other Name: PF-3512676, ProMune
Study Arms  ICMJE
  • Experimental: Cohort 1
    0.01 mg/kg CPG 7909 plus Herceptin®
    Interventions:
    • Drug: CPG 7909
    • Drug: Herceptin®
  • Experimental: Cohort 2
    0.04 mg/kg CPG 7909 plus Herceptin®
    Interventions:
    • Drug: CPG 7909
    • Drug: Herceptin®
  • Experimental: Cohort 3
    0.16 mg/kg CPG 7909 plus Herceptin®
    Interventions:
    • Drug: CPG 7909
    • Drug: Herceptin®
  • Experimental: Cohort 4
    0.32 mg/kg CPG 7909 plus Herceptin®
    Interventions:
    • Drug: CPG 7909
    • Drug: Herceptin®
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: December 15, 2008)
12
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
58
Actual Study Completion Date  ICMJE June 2003
Actual Primary Completion Date June 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

INCLUSION CRITERIA Inclusion Criteria

  • Histologically confirmed breast cancer with metastases.
  • Tumor that has overexpression of HER2 as documented by being either FISH-positive or HER2/neu 3+ confirmed by immunohistochemistry.
  • Patients must be candidates for single agent Herceptin treatment according to the Herceptin® label.

Exclusion Criteria

  • Any prior therapy with anthracycline + Herceptin®.
  • Significant cardiovascular disease (e.g., NYHA class 3 congestive heart failure, myocardial infarction within the past 6 months, unstable angina; coronary angioplasty within the past 6 months, uncontrolled atrial or ventricular cardiac arrhythmias) or left ventricular ejection fraction < 50%.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
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 NCT00031278
Other Study ID Numbers  ICMJE C005
C005
A8501020
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Harold Burstein, M.D., Ph.D. Dana-Farber Cancer Institute
PRS Account Pfizer
Verification Date May 2011

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