ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
A Study To Assess The Safety Of Administering CP-675,206 As A One Hour Infusion In Patients With Surgically Incurable Advanced Melanoma

This study is currently recruiting participants.
Verified by Pfizer, October 2008

Sponsored by: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00585000
  Purpose

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 Intervention Phase
Melanoma
Drug: CP-675,206
Phase I

MedlinePlus related topics:   Cancer    Melanoma   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 = 05Dec2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • •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 05Dec2008 ] [ Designated as safety issue: No ]
  • •To evaluate the overall safety and tolerability of CP 675,206 in this population [ Time Frame: Last patient dosed = estimated 05Dec2008 ] [ Designated as safety issue: No ]
  • •To characterize the pharmacokinetics (PK) of CP 675,206 following a one hour infusion [ Time Frame: Last PK timepoint obtained =estiamted 04Sep2009 ] [ Designated as safety issue: No ]
  • •To monitor for human anti human (HAHA) response to CP 675,206 [ Time Frame: Last HAHA time point obtain =estimated 05Dec2008 ] [ Designated as safety issue: No ]
  • •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 04Sep2009 ] [ Designated as safety issue: No ]

Estimated Enrollment:   110
Study Start Date:   December 2007
Estimated Study Completion Date:   July 2009

Arms Assigned Interventions
1: Experimental 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.

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

Criteria

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00585000

Contacts
Contact: Pfizer Oncology Clinical Trial Information Service     1-877-369-9753     PfizerCancerTrials@emergingmed.com    
Contact: Pfizer CT.gov Call Center     1-800-718-1021    

Locations
United States, Arizona
Pfizer Investigational Site     Active, not recruiting
      Scottsdale, Arizona, United States, 85260
United States, California
Pfizer Investigational Site     Active, not recruiting
      Los Angeles, California, United States, 90095
Pfizer Investigational Site     Active, not recruiting
      Los Angeles, California, United States, 90095-6970
United States, Colorado
Pfizer Investigational Site     Active, not recruiting
      Aurora, Colorado, United States, 80045
United States, Georgia
Pfizer Investigational Site     Recruiting
      Atlanta, Georgia, United States, 30322
United States, Indiana
Pfizer Investigational Site     Recruiting
      Indianapolis, Indiana, United States, 46202
United States, Kentucky
Pfizer Investigational Site     Active, not recruiting
      Louisville, Kentucky, United States, 40202
United States, North Carolina
Pfizer Investigational Site     Active, not recruiting
      Durham, North Carolina, United States, 27710

Sponsors and Collaborators
Pfizer

Investigators
Study Director:     Pfizer CT.gov Call Center     Pfizer    
  More Information


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

Responsible Party:   Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:   A3671022
First Received:   December 21, 2007
Last Updated:   October 17, 2008
ClinicalTrials.gov Identifier:   NCT00585000
Health Authority:   United States: Food and Drug Administration

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:
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on October 28, 2008




Links to all studies - primarily for crawlers