CPG 7909 in Patients With Cutaneous T-Cell Lymphoma - Tabular View

Tracking Information

First Received Date ^ICMJE

August 8, 2002

Last Updated Date

February 11, 2009

Start Date ^ICMJE

January 2003

Primary Completion Date

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

Current Primary Outcome Measures ^ICMJE

Safety: Adverse events, vital signs, clinical and laboratory parameters, physical exams, and ECGs [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Efficacy: Evaluate tumor response as measured by the Composite Assessment of Index Lesion Disease Severity (CA). The primary endpoint will be the overall tumor response rate as assessed by the CA. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Safety: Adverse events, vital signs, clinical and laboratory parameters, physical exams, and ECGs
Efficacy: Evaluate tumor response as measured by the Composite Assessment of Index Lesion Disease Severity (CA). The primary endpoint will be the overall tumor response rate as assessed by the CA.

Change History

Complete list of historical versions of study NCT00043420 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Secondary efficacy endpoints include disease response assessed by the PGA, duration of overall response, duration of CCR, duration of PR, time to response and time to progression of disease. [ Time Frame: indeterminate ]

Original Secondary Outcome Measures ^ICMJE

Secondary efficacy endpoints include disease response assessed by the PGA, duration of overall response, duration of CCR, duration of PR, time to response and time to progression of disease.

Descriptive Information

Brief Title ^ICMJE

CPG 7909 in Patients With Cutaneous T-Cell Lymphoma

Official Title ^ICMJE

A Phase I/II Open Label, Multi-Center Study For The Evaluation Of Pf-3512676 (CPG 7909) In Patients With Stage Ib To Iva Cutaneous T-Cell Lymphoma

Brief Summary

To assess the effect of CPG 7909 Injection on Cutaneous T-cell lymphoma and the safety of CPG 7909 Injection in patients with this cancer.

Detailed Description

Study Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Lymphoma, T-Cell, Cutaneous

Intervention ^ICMJE

Drug: PF-3512676

Study Arms / Comparison Groups

Experimental: Escalating dose groups: 0.08 mg/kg PF-3512676 Injection
Experimental: Escalating dose groups: 0.16 mg/kg PF-3512676 Injection
Experimental: Escalating dose groups: 0.24 mg/kg PF-3512676 Injection
Experimental: Escalating dose groups: 0.28 mg/kg PF-3512676 Injection
Experimental: Escalating dose groups: 0.32 mg/kg PF-3512676 Injection
Experimental: Escalating dose groups: 0.36 mg/kg PF-3512676 Injection
Experimental: Phase II: 10 mg flat dose (random assignment in Phase II)
Experimental: Weekly subcutaneous injections of 25 mg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.

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

March 2007

Primary Completion Date

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

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients 18 years or older with biopsy (histopathologically) confirmed cutaneous T-cell lymphoma (limited to mycosis fungoides (MF)) who have had prior therapy with at least one and no more than 3 systemic treatments.

Exclusion Criteria:

Patients with visceral involvement, serious infection or illness including human immunodeficiency virus infection, or a Karnofsky Performance Status (KPS) < 60 will be excluded.

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

Administrative Information

NCT ID ^ICMJE

NCT00043420

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Study ID Numbers ^ICMJE

C014, CO14, A8501014

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

February 2009

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