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A Phase I/II Open Label, Multi-Center, Dose-Escalation Study Of Subcutaneous CPG 7909 Plus Herceptin® In Patients With Metastatic Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Carcinoma, Breast

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Trial Information

A Phase I/II Open Label, Multi-Center, Dose-Escalation Study Of Subcutaneous CPG 7909 Plus Herceptin® In Patients With Metastatic Breast Cancer


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 may have had up to three prior chemotherapy regimens for metastatic disease,
which may have been given in combination with Herceptin® and which may have been
discontinued due to toxicities. In addition, patients may have had adjuvant
chemotherapy.

- Phase II only: Must have measurable disease by RECIST criteria (defined in section 8)
with at least one lesion that can be accurately measured in at least one dimension
(longest diameter to be recorded) as > 20 mm with conventional techniques, or as > 10
mm with spiral CT scan

Exclusion Criteria:

- Any prior therapy with anthracycline + Herceptin® concurrently

- 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%

- Pre-existing autoimmune or antibody-mediated diseases including but not limited to:
systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's
syndrome, autoimmune thrombocytopenia

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase I: To evaluate the safety and tolerability of several dose levels of CPG 7909 (up to a maximum of 0.16 mg/kg) and to determine the maximum tolerated dose (MTD)* of CPG 7909 in combination with Herceptin®

Outcome Time Frame:

24 weeks

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

C015

NCT ID:

NCT00043394

Start Date:

September 2002

Completion Date:

October 2003

Related Keywords:

  • Carcinoma, Breast
  • CpG 7909 subcutaneous injection combination with Herceptin® metastatic breast cancer.
  • Breast Neoplasms
  • Carcinoma

Name

Location

Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteDetroit, Michigan  48201
Pfizer Investigational SiteCincinnait, Ohio  45236
Pfizer Investigational SiteClearwater, Florida  33761
Pfizer Investigational SiteFarmington, Connecticut  06030-3805
Pfizer Investigational SiteWashington, District of Columbia  20007-2197
Pfizer Investigational SiteBurlington, Vermont  05401-3456