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CP-675,206 Versus Either Dacarbazine Or Temozolomide In Patients Without Prior Therapy

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ClinicalTrials.gov Identifier: NCT00257205
Recruitment Status : Completed
First Posted : November 22, 2005
Last Update Posted : July 2, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
This is a Phase 3, multi-national, open-label, 2-arm randomized study in patients with surgically incurable metastatic melanoma who have received no prior chemotherapy, or biochemotherapy for the treatment of metastatic disease. The primary objective of this trial is to compare overall survival for patients with advanced melanoma who are randomized to receive CP-675,206 with that of patients who are randomized to receive either dacarbazine or temozolomide (investigator choice)

Condition or disease Intervention/treatment Phase
Melanoma Drug: dacarbazine Drug: CP-675,206 Drug: temozolomide Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 655 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Open Label, Randomized, Comparative Study Of CP-675,206 And Either Dacarbazine Or Temozolomide In Patients With Advanced Melanoma
Study Start Date : March 2006
Primary Completion Date : August 2010
Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: B
Choice of one or the other Dacarbazine or Temozolomide(CP-675,206) (choice)
Drug: dacarbazine
decarbazine 1000 mg/m2 IV Q 21 days x 12
Drug: temozolomide
temozolomide 200 mg/m2 orally on Days 1-5 every 28 days x 12
Experimental: A Drug: CP-675,206
CP-675,206 15 mg/kg IV Q 90 days x 4
Other Name: anti-CTLA4 human monoclonal antibody



Primary Outcome Measures :
  1. overall survival [ Time Frame: August 2010 ]

Secondary Outcome Measures :
  1. adverse events [ Time Frame: 1 year ]
  2. PFS at 6 months [ Time Frame: 6 months ]
  3. objective tumor response [ Time Frame: 1 year ]
  4. Durable response [ Time Frame: 6 months ]
  5. pharmacokinetics endpoints [ Time Frame: 15 months ]
  6. pharmacogenomic endpoints [ Time Frame: 1 year ]
  7. HQol [ Time Frame: 1 year ]
  8. healthcare resource utilization and loss of productivity [ Time Frame: 1 year ]
  9. human antihuman antibody response for patients in Arm A [ Time Frame: 15 months ]


Information from the National Library of Medicine

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

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

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 ClinicalTrials.gov identifier (NCT number): NCT00257205


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Sponsors and Collaborators
AstraZeneca

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00257205     History of Changes
Other Study ID Numbers: A3671009
First Posted: November 22, 2005    Key Record Dates
Last Update Posted: July 2, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Temozolomide
Dacarbazine
Tremelimumab
Antibodies, Monoclonal
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs