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CPG 7909 Plus Herceptin� In Patients With Metastatic Breast Cancer

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Carcinoma, Breast

Intervention: 0.04 mg/kg CpG 7909 (Drug); Herceptin® (Drug); 0.08 mg/kg CpG 7909 (Drug); Herceptin® (Drug); 0.12 mg/kg CpG 7909 (Drug); Herceptin® (Drug); 0.16 mg/kg CpG 7909 (Drug); Herceptin® (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

To determine the safety and efficacy of CPG 7909 Injection given with Herceptin to patients with metastatic breast cancer.

Clinical Details

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

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

Primary outcome:

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®

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.

Secondary outcome:

Phase I To evaluate tumor response, duration of response, time to disease progression, ECOG performance status, and survival time.

Phase II To evaluate duration of response, time to disease progression, ECOG performance status, and survival time.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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 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

Locations and Contacts

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, 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

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: September 2002
Last updated: March 11, 2009

Page last updated: August 23, 2015

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