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

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

Tracking Information

• First Submitted Date: February 28, 2002
• First Posted Date: March 1, 2002
• Last Update Posted Date: May 30, 2011
• Study Start Date: October 2001
• Actual Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Not Provided

Current Secondary Outcome Measures (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: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety And Efficacy Study Of The Combination Of CpG 7909 And Herceptin In Patients With Metastatic Breast Cancer
• Official Title: 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: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Carcinoma, Metastatic Breast

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 15, 2008): 12
• Original Enrollment (submitted: June 23, 2005): 58
• Actual Study Completion Date: June 2003
• Actual Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00031278
• Other Study ID Numbers: C005; C005; A8501020
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Principal Investigator: Harold Burstein, M.D., Ph.D.; Dana-Farber Cancer Institute

• PRS Account: Pfizer
• Verification Date: May 2011