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

Tracking Information

First Received Date ^ICMJE

August 8, 2002

Last Updated Date

March 11, 2009

Start Date ^ICMJE

September 2002

Primary Completion Date

June 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Adverse Events and DLTs will be evaluated by the Investigator and summarized. [ Time Frame: indeterminate ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Safety: Safety monitoring will be performed by the Investigator according to standard of care for the cancer being treated. Adverse events, vital signs, clinical and laboratory parameters, and physical exams will be assessed.

Change History

Complete list of historical versions of study NCT00043368 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

No formal statistical analysis of this study will be conducted. All clinical data may be summarized and included in data listings. [ Time Frame: indeterminate ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety Study

Condition ^ICMJE

Melanoma
Breast Neoplasms
Carcinoma, Renal Cell
Lymphoma, T-Cell
Carcinoma, Non-Small-Cell Lung

Intervention ^ICMJE

Drug: PF-3512676

Study Arms / Comparison Groups

Experimental: Patients will be treated with the same dosing regimen and schedule of PF-3512676 Injection with which they were treated at the end of the previous PF-3512676 Injection trial. Any proposed changes to their schedule/regimen will be at the discretion of the treating physician, following consultation with Coley.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2007

Primary Completion Date

June 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Germany

Administrative Information

NCT ID ^ICMJE

NCT00043368

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Study ID Numbers ^ICMJE

C016, CO16, A8501015

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP