Patients with metastatic or recurrent malignancies who have stable disease or who have responded to CPG 7909 Injection therapy.
Conditions
Interventions
Product Name: PF-3512676 (formerly known as ProMune)
Product Code: PF-3512676 (formerly known as CPG 7909 Injection)
Pharmaceutical Form: Solution for injection
Sponsors
Pfizer Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria from the patient's prior study protocol should be used. Furthermore, the patients must meet the following criteria: Immediate (within 4 weeks) prior completion of a clinical trial with CPG 7909 Injection alone or in combination with other anti-neoplastic treatment for malignancy. >= 18 years of age Patients of reproductive potential must agree to use an effective (>= 90% reliability) form of birth control during the study and for 4 weeks following the last study drug administration Women of reproductive potential: negative urine pregnancy test Signed Informed Consent Form Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Pre-existing autoimmune or antibody-mediated diseases including: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, autoimmune thrombocytopenia, but excluding controlled thyroid disease or the presence of autoantibodies without clinical autoimmune disease The patient has received any antineoplastic therapy since completing a prior trial with CPG 7909 Injection; or has participated in another clinical trial following participation in a trial with CPG 7909 Injection. Breast feeding at time of study entry Suspected or confirmed poor compliance, mental instability or prior or current alcohol or drug abuse deemed by the investigator to be likely to affect their ability to sign the informed consent or undergo study procedures Presentation with, or a recent history (within 24 hours) of a fever >= 38.2°C or symptoms of significant local infection or systemic infection, including urinary tract infections - such patients will be defferred from enrolment at least until 48 hours after illness has resolved Any other significant medical history, including laboratory results, deemed by the investigator to be likely to interfere with the patient's continued participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To allow patients who have completed a clinical trial with CPG 7909 Injection or have reached a maximum number of cycles with a combination product (such as chemotherapy) to continue treatment with CPG 7909 if their cancer has responded or stabilised in response to treatment with CPG 7909 Injection alone or in combination with other anti-neoplastic agents.;Secondary Objective: Not applicable.;Primary end point(s): This is a continuation study. Safety monitoring will be performed by the Investigator according to standard of care for the cancer being treated. Adverse events monitoring and vital signs will be monitored at each visit. Clinical and laboratory parameters and physical examinations will be performed as standard of care for the cancer being treated. | — |
Countries
United Kingdom
Outcome results
None listed