A Study To Assess The Safety Of Administering CP-675,206 As A One Hour Infusion In Patients With Surgically Incurable Advanced Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00585000
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : January 2, 2008
Last Update Posted : June 6, 2012
Information provided by (Responsible Party):

Brief Summary:
This will show if CP-675,206 can be administered safely as an intravenous infusion lasting one hour. CP 675,206 already has been administered to 835 subjects over 1.0 - 7.5 hours.

Condition or disease Intervention/treatment Phase
Melanoma Drug: CP-675,206 Phase 1

Detailed Description:
This study was prematurely discontinued on April 28, 2008 because a concomitant Phase 3 study met pre-specified futility criteria. The decision to close enrollment early was not based on any safety concerns.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open Label, Single Arm Study To Establish The Safety Of Administering CP 675,206 As A One Hour Infusion In Patients With Surgically Incurable Stage III Or Stage IV Melanoma
Study Start Date : December 2007
Primary Completion Date : January 2010
Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: CP-675,206
15 mg/kg. IV (in the vein) over 1 hour on Day 1 of each 90 day cycle. Number of cycles: maximum of 4 cycles unless progression of disease or unacceptable toxicity.

Primary Outcome Measures :
  1. To assess safety and tolerability during and for 1 hour following a 15 mg/kg dose of CP 675,206 administered as a one hour infusion. [ Time Frame: Last patient dosed = 31Dec2009 ]

Secondary Outcome Measures :
  1. To monitor for human anti human (HAHA) response to CP 675,206 [ Time Frame: Last HAHA time point obtain =estimated 31Dec2009 ]
  2. To assess evidence of anti tumor activity as measured by best overall response rate using Response Evaluation Criteria in Solid Tumors (RECIST) criteria, duration of response, progression free survival [ Time Frame: Last RECIST obtained = estimated 31Dec2009 ]
  3. To identify potential relationships between polymorphisms in the Cytotoxic T lymphocyte associated antigen 4 (CTLA4), Fcgamma receptor IIa (FcgRIIa), IgG2a genes with safety and/or immune response of subjects treated with CP 675,206 [ Time Frame: Last PG obtained = estimated 31Dec2009 ]
  4. To evaluate the overall safety and tolerability of CP 675,206 in this population [ Time Frame: Last patient dosed = estimated 31Dec2009 ]
  5. To characterize the pharmacokinetics (PK) of CP 675,206 following a one hour infusion [ Time Frame: Last PK timepoint obtained =estiamted 31Dec2009 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically confirmed melanoma that is surgically incurable Note: Prior therapies for melanoma, including cancer vaccines, are permitted but are not required. There is no limit to the number of prior regimens for melanoma a patient may have received.
  • Evidence of at least one lesion
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • CT scan of the brain with contrast or MRI of the brain within 6 weeks prior to enrollment showing no evidence of active brain metastases. PET scans and PET/CT scans are also acceptable.

Exclusion Criteria:

  • Previous treatment with other anti CTLA4 agents (eg, ipilimumab, MDX 010).
  • Previously randomized to Pfizer study A3671009: A Phase 3, Open Label, Randomized Comparative Study of CP 675,206 and Either Dacarbazine or Temozolomide in Patients with Advanced Melanoma.
  • History of chronic autoimmune disease (eg, Addison's disease, multiple sclerosis, Graves disease, Hashimoto's thyroiditis, psoriasis, rheumatoid arthritis, systemic lupus erythematosus, hypophysitis, etc.).
  • History of inflammatory bowel disease (eg, Crohn's disease or ulcerative colitis), celiac disease, or other chronic gastrointestinal conditions associated with diarrhea, or current acute colitis of any origin, and any history of diverticulitis (even a single episode) or evidence of diverticulitis at baseline, including evidence limited to CT scan only.
  • Brain metastases that have not been adequately treated with surgery or stereotactic radiosurgery and have not been stable at least 3 months prior to enrollment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00585000

United States, Arizona
Research Site
Scottsdale, Arizona, United States, 85258
United States, California
Research Site
Los Angeles, California, United States, 90095-7423
Research Site
Los Angeles, California, United States, 90095
United States, Colorado
Research Site
Aurora, Colorado, United States, 80045
United States, Georgia
Research Site
Atlanta, Georgia, United States, 30322
United States, Indiana
Research Site
Indianapolis, Indiana, United States, 46202
United States, Kentucky
Research Site
Louisville, Kentucky, United States, 40202
United States, North Carolina
Research Site
Durham, North Carolina, United States, 27710
Sponsors and Collaborators

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: AstraZeneca Identifier: NCT00585000     History of Changes
Other Study ID Numbers: A3671022
First Posted: January 2, 2008    Key Record Dates
Last Update Posted: June 6, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs