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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00257205
• Date of registration: 18/11/2005
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca
• Public title: CP-675,206 Versus Either Dacarbazine Or Temozolomide In Patients Without Prior Therapy
• Scientific title: A Phase 3, Open Label, Randomized, Comparative Study Of CP-675,206 And Either Dacarbazine Or Temozolomide In Patients With Advanced Melanoma
• Date of first enrolment: March 2006
• Target sample size: 655
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00257205
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Austria, Belgium, Canada, France, Germany, Greece, Israel, Italy, Mexico, Netherlands, Poland, Russian Federation, Slovakia, South Africa, Spain, Sweden, Switzerland, United Kingdom, United States

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Melanoma

Intervention(s)

Drug: dacarbazine

Drug: CP-675,206

Drug: temozolomide

Primary Outcome(s)

overall survival [Time Frame: August 2010]

Secondary Outcome(s)

objective tumor response [Time Frame: 1 year]

PFS at 6 months [Time Frame: 6 months]

Durable response [Time Frame: 6 months]

healthcare resource utilization and loss of productivity [Time Frame: 1 year]

human antihuman antibody response for patients in Arm A [Time Frame: 15 months]

pharmacokinetics endpoints [Time Frame: 15 months]

pharmacogenomic endpoints [Time Frame: 1 year]

adverse events [Time Frame: 1 year]

HQol [Time Frame: 1 year]

Secondary ID(s)

A3671009

Source(s) of Monetary Support

Please refer to primary and secondary sponsors