CPG 7909 Plus Herceptin® In Patients With Metastatic Breast Cancer
A Phase I/II Open Label, Multi-Center, Dose-Escalation Study Of Subcutaneous CPG 7909 Plus Herceptin® In Patients With Metastatic Breast Cancer
2 other identifiers
interventional
16
1 country
12
Brief Summary
To determine the safety and efficacy of CPG 7909 Injection given with Herceptin to patients with metastatic breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2002
Shorter than P25 for phase_2
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2002
CompletedFirst Posted
Study publicly available on registry
August 12, 2002
CompletedStudy Start
First participant enrolled
September 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2003
CompletedMarch 12, 2009
March 1, 2009
1.1 years
August 8, 2002
March 11, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Secondary Outcomes (2)
Phase I To evaluate tumor response, duration of response, time to disease progression, ECOG performance status, and survival time.
24 weeks
Phase II To evaluate duration of response, time to disease progression, ECOG performance status, and survival time.
24 weeks
Study Arms (4)
Cohort 1
EXPERIMENTAL0.04 mg/kg CpG 7909
Cohort 2
EXPERIMENTAL0.08 mg/kg CpG 7909
Cohort 3
EXPERIMENTAL0.12 mg/kg CpG 7909 Injection once weekly
Cohort 4
EXPERIMENTAL0.16 mg/kg CpG 7909
Interventions
0.04 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks
Herceptin® (maintenance dose per the manufacturer's directions) followed by a subcutaneous injection of CpG 7909.
0.08 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks
0.12 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks
0.16 mg/kg CpG 7909 by subcutaneous Injection once weekly until progression or 24 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (12)
Pfizer Investigational Site
Berkely, California, 94704, United States
Pfizer Investigational Site
Orange, California, 92868, United States
Pfizer Investigational Site
Palm Springs, California, 92262, United States
Pfizer Investigational Site
New Haven, Connecticut, 06510, United States
Pfizer Investigational Site
Washington D.C., District of Columbia, 20007-2197, United States
Pfizer Investigational Site
Plantation, Florida, 33324, United States
Pfizer Investigational Site
Ann Arbor, Michigan, 48109, United States
Pfizer Investigational Site
Dearborn, Michigan, 48126-2641, United States
Pfizer Investigational Site
Detroit, Michigan, 48202, United States
Pfizer Investigational Site
West Bloomfield, Michigan, 48322-3013, United States
Pfizer Investigational Site
Cleveland, Ohio, 44195, United States
Pfizer Investigational Site
Burlington, Vermont, 05401-3456, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 8, 2002
First Posted
August 12, 2002
Study Start
September 1, 2002
Primary Completion
October 1, 2003
Study Completion
October 1, 2003
Last Updated
March 12, 2009
Record last verified: 2009-03