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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00257205
First received: November 18, 2005
Last updated: June 25, 2012
Last verified: June 2012
  Purpose
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 Intervention Phase
Melanoma
Drug: dacarbazine
Drug: CP-675,206
Drug: temozolomide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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

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

Enrollment: 655
Study Start Date: March 2006
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
  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: NCT00257205

  Show 144 Study Locations
Sponsors and Collaborators
AstraZeneca
  More Information

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
Study First Received: November 18, 2005
Last Updated: June 25, 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

ClinicalTrials.gov processed this record on May 25, 2017