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A Phase 3, Open Label, Randomized, Comparative Study Of CP-675,206 And Either Dacarbazine Or Temozolomide In Patients With Advanced Melanoma


Phase 3
18 Years
N/A
Not Enrolling
Both
Melanoma

Thank you

Trial Information

A Phase 3, Open Label, Randomized, Comparative Study Of CP-675,206 And Either Dacarbazine Or Temozolomide In Patients With Advanced Melanoma


Inclusion Criteria:



- Surgically incurable melanoma, either Stage IV or IIIC with N3 status for regional
lymph nodes and in-transit or satellite lesions.

- Serum lactic acid dehydrogenase (LDH) <= 2 x ULN

- ECOG performance status of 0 or 1

Exclusion Criteria:

- Received any systemic therapy for metastatic melanoma except post-surgical adjuvant
treatment with cytokines (eg, alpha-interferon or GM-CSF) or with vaccines after
complete resection of melanoma.

- History of brain metastases

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival

Outcome Time Frame:

August 2010

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

A3671009

NCT ID:

NCT00257205

Start Date:

March 2006

Completion Date:

August 2010

Related Keywords:

  • Melanoma
  • Melanoma

Name

Location

Research SiteAlabaster, Alabama  
Research SiteMesa, Arizona  
Research SiteBentonville, Arkansas  
Research SiteAnaheim, California  
Research SiteBoulder, Colorado  
Research SiteDanbury, Connecticut  
Research SiteBoca Raton, Florida  
Research SiteArlington Heights, Illinois  
Research SiteBloomington, Indiana  
Research SiteBaltimore, Maryland  
Research SiteBranson, Missouri  
Research SiteGrand Island, Nebraska  
Research SiteLas Vegas, Nevada  
Research SiteBelleville, New Jersey  
Research SiteAlbany, New York  
Research SiteAsheville, North Carolina  
Research SiteAkron, Ohio  
Research SiteAllentown, Pennsylvania  
Research SiteAbilene, Texas  
Research SiteIvins, Utah  
Research SiteAuburn, Washington