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

Phase 3

Completed

• Conditions: Melanoma
• Interventions: Drug: CP-675,206; Drug: dacarbazine; Drug: temozolomide

• Registration Number: NCT00257205
• Lead Sponsor: 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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-11-18
• Study First Submitted QC: 2005-11-18
• Study First Posted: 2005-11-22
• Study Start: 2006-03
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Disposition First Submitted: 2011-01-03
• Disposition First Submitted QC: 2011-04-26
• Disposition First Posted: 2011-05-04
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-25
• Last Update Posted: 2012-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 655

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	temozolomide	Choice of one or the other Dacarbazine or Temozolomide(CP-675,206) (choice)
A	CP-675,206	-
B	dacarbazine	Choice of one or the other Dacarbazine or Temozolomide(CP-675,206) (choice)

Primary Outcome Measures

Name	Time	Method
overall survival	August 2010

Secondary Outcome Measures

Name	Time	Method
pharmacokinetics endpoints	15 months
pharmacogenomic endpoints	1 year
HQol	1 year
healthcare resource utilization and loss of productivity	1 year
human antihuman antibody response for patients in Arm A	15 months
adverse events	1 year
PFS at 6 months	6 months
objective tumor response	1 year
Durable response	6 months

Trial Locations

Locations (1)

Research Site; 🇬🇧 Wolverhampton, United Kingdom