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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
History of Changes
  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
Endpoint Classification: Efficacy Study
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:

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • overall survival [ Time Frame: August 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • adverse events [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • PFS at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • objective tumor response [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Durable response [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • pharmacokinetics endpoints [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • pharmacogenomic endpoints [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • HQol [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • healthcare resource utilization and loss of productivity [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • human antihuman antibody response for patients in Arm A [ Time Frame: 15 months ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00257205

  Show 144 Study Locations
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: NCT00257205     History of Changes
Other Study ID Numbers: A3671009
Study First Received: November 18, 2005
Last Updated: June 25, 2012
Health Authority: United States: Food and Drug Administration

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
Antibodies, Monoclonal
Dacarbazine
 Temozolomide
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013