Study of CP-675,206 in Refractory Melanoma - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00254579

Purpose

CP-675,206 is a fully human monoclonal antibody (mAb). It binds to the CTLA4 molecule, which is expressed on the surface of activated T lymphocytes. CP-675,206 is thought to stimulate patients' immune systems to attack their tumors. CP-675,206 is not expected to have a direct effect on tumor cells. CP-675,206 been shown to induce durable tumor responses in patients with metastatic melanoma in Phase 1 and Phase 2 clinical studies.

Condition	Intervention	Phase
Refractory Melanoma	Drug: CP-675,206	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
Official Title:	A Phase 2, Open Label, Single Arm Study To Evaluate The Efficacy, Safety, Tolerability And Pharmacokinetics Of CP-675,206 In Patients With Advanced Refractory And/Or Relapsed Melanoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

To assess the anti-tumor efficacy, as determined by objective response rate, of intravenous CP-675,206 administered at a dose of 15 mg/kg every 90 days to patients with relapsed or refractory advanced melanoma [ Time Frame: Tumor response is assessed every 2-3 months until disease progression ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety, PK, Survival, health-related QoL [ Time Frame: At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug ] [ Designated as safety issue: No ]

Estimated Enrollment:	215
Study Start Date:	December 2005
Estimated Study Completion Date:	December 2010
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
15 mg/kg CP-675,206: Experimental	Drug: CP-675,206 15 mg/kg Q12W dosing regimen

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Surgically incurable Stage III or IV melanoma
One prior systemic treatment for metastatic melanoma
Measurable disease
Eastern Cooperative Oncology Group (ECOG) PS = 0 or 1

Exclusion Criteria:

Melanoma of ocular origin
Received prior vaccine
Received prior CTLA4-inhibiting agent
History of, or significant risk for, chronic inflammatory or autoimmune disease
Potential requirement for systemic corticosteroids

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00254579

Show 64 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A3671008
Study First Received:	November 14, 2005
Last Updated:	August 9, 2009
ClinicalTrials.gov Identifier:	NCT00254579 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

refractory melanoma, malignant melanoma

Study placed in the following topic categories:

Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma

Nevus
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Neuroectodermal Tumors
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue
Nevi and Melanomas
Neuroendocrine Tumors
Melanoma

ClinicalTrials.gov processed this record on September 02, 2009