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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Melanoma

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

Last patient dosed = 31Dec2009

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

A3671022

NCT ID:

NCT00585000

Start Date:

December 2007

Completion Date:

January 2010

Related Keywords:

  • Melanoma
  • Melanoma

Name

Location

Research SiteMesa, Arizona  
Research SiteAnaheim, California  
Research SiteBoulder, Colorado  
Research SiteAlbany, Georgia  
Research SiteBloomington, Indiana  
Research SiteAshland, Kentucky  
Research SiteAsheville, North Carolina