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NCT00043368 Clinical Trial

PF-3512676 (CPG 7909) Injection For Patients Who Completed An Oncology Study Using PF-3512676 (CPG 7909)

Melanoma Clinical Trial

Official title:
A Continuation Study Of PF-3512676 (CPG 7909) Injection In Patients With Metastatic Or Recurrent Malignancies Who Have Stable Disease Or Who Have Responded To Pf-3512676 Injection Therapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00043368
Other study ID # C016
Secondary ID CO16, A8501015
Status Completed
Phase Phase 2
First received August 8, 2002
Last updated March 11, 2009
Start date September 2002
Est. completion date June 2007

Study information
Verified date March 2009
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This protocol allows patients who completed Coley oncology studies using PF-3512676 (CPG 7909) Injection to continue receiving the treatment until disease progression.

Recruitment information / eligibility
Status Completed
Enrollment 31
Est. completion date June 2007
Est. primary completion date June 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

Immediate (within 4 weeks) prior completion of a clinical trial of PF-3512676 Injection alone or in combination with other anti-neoplastic treatment for malignancy.

Exclusion Criteria:

The patient has received any anti-neoplastic therapy since completing a prior trial with PF-3512676 Injection, or has participated in another clinical trial following participation in a trial with PF-3512676 Injection.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• PF-3512676
PF-3512676 IV at doses: 0.01mg/kg, 0.16mg/kg and 0.32mg/kg PF-3512676 Injection given by subcutaneous injection at doses: 0.04mg/kg, 0.16mg/kg, 0.20mg/kg, 0.28mg/kg, 0.32mg/kg, 6mg, 10mg, 40mg.

Locations
Country Name City State
Germany Pfizer Investigational Site Koeln
United States Pfizer Investigational Site Ann Arbor Michigan
United States Pfizer Investigational Site Asheville North Carolina
United States Pfizer Investigational Site Berkely California
United States Pfizer Investigational Site Bonita Springs Florida
United States Pfizer Investigational Site Bradenton Florida
United States Pfizer Investigational Site Cape Coral Florida
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Collierville Tennessee
United States Pfizer Investigational Site Fort Myers Florida
United States Pfizer Investigational Site Fort Myers Florida
United States Pfizer Investigational Site Gilroy California
United States Pfizer Investigational Site Hollister California
United States Pfizer Investigational Site Livingston New Jersey
United States Pfizer Investigational Site Los Angeles California
United States Pfizer Investigational Site Los Angeles California
United States Pfizer Investigational Site Memphis Tennessee
United States Pfizer Investigational Site Memphis Tennessee
United States Pfizer Investigational Site Naples Florida
United States Pfizer Investigational Site New Haven Connecticut
United States Pfizer Investigational Site Olive Branch Mississippi
United States Pfizer Investigational Site Oxford Mississippi
United States Pfizer Investigational Site Palm Springs California
United States Pfizer Investigational Site Plantation Florida
United States Pfizer Investigational Site Port Charlotte Florida
United States Pfizer Investigational Site Portland Oregon
United States Pfizer Investigational Site Sarasota Florida
United States Pfizer Investigational Site Stanford California
United States Pfizer Investigational Site Venice Florida
United States Pfizer Investigational Site Venice Florida
United States Pfizer Investigational Site Vincennes Indiana

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse Events and DLTs will be evaluated by the Investigator and summarized. indeterminate Yes
Secondary No formal statistical analysis of this study will be conducted. All clinical data may be summarized and included in data listings. indeterminate Yes
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