Carcinoma, Breast Clinical Trial
Official title:
A Phase I/II Open Label, Multi-Center, Dose-Escalation Study Of Subcutaneous CPG 7909 Plus Herceptin® In Patients With Metastatic Breast Cancer
| Verified date | March 2009 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
To determine the safety and efficacy of CPG 7909 Injection given with Herceptin to patients with metastatic breast cancer.
| Status | Completed |
| Enrollment | 16 |
| Est. completion date | October 2003 |
| Est. primary completion date | October 2003 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Pfizer Investigational Site | Ann Arbor | Michigan |
| United States | Pfizer Investigational Site | Berkely | California |
| United States | Pfizer Investigational Site | Burlington | Vermont |
| United States | Pfizer Investigational Site | Cleveland | Ohio |
| United States | Pfizer Investigational Site | Dearborn | Michigan |
| United States | Pfizer Investigational Site | Detroit | Michigan |
| United States | Pfizer Investigational Site | New Haven | Connecticut |
| United States | Pfizer Investigational Site | Orange | California |
| United States | Pfizer Investigational Site | Palm Springs | California |
| United States | Pfizer Investigational Site | Plantation | Florida |
| United States | Pfizer Investigational Site | Washington | District of Columbia |
| United States | Pfizer Investigational Site | West Bloomfield | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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® | 24 weeks | Yes | |
| Primary | Phase II: To evaluate tumor response and safety of CPG 7909 (at the MTD as determined in Phase I) in combination with Herceptin® in patients with metastatic breast cancer. | 24 weeks | Yes | |
| Secondary | Phase I To evaluate tumor response, duration of response, time to disease progression, ECOG performance status, and survival time. | 24 weeks | No | |
| Secondary | Phase II To evaluate duration of response, time to disease progression, ECOG performance status, and survival time. | 24 weeks | No |