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 has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00585000
First received: December 21, 2007
Last updated: June 5, 2012
Last verified: June 2012
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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 = 31Dec2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To monitor for human anti human (HAHA) response to CP 675,206 [ Time Frame: Last HAHA time point obtain =estimated 31Dec2009 ] [ 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 31Dec2009 ] [ Designated as safety issue: No ]
  • 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 ] [ 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 31Dec2009 ] [ 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 31Dec2009 ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: December 2007
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Arizona
Research Site
Scottsdale, Arizona, United States, 85258
United States, California
Research Site
Los Angeles, California, United States, 90095
Research Site
Los Angeles, California, United States, 90095-7423
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
AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00585000     History of Changes
Other Study ID Numbers: A3671022
Study First Received: December 21, 2007
Last Updated: June 5, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on October 23, 2014