Study to Compare the Efficacy and Safety of CC-5013 Vs. Placebo in Subjects With Metastatic Malignant Melanoma.

Subjects are randomized to one of two treatment arms. All subjects are screened for eligibility within 28 days prior to randomization. The study consists of a treatment phase and a follow-up phase. Subjects are treated in repeating 4 week cycles.

Official Title

Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of CC-5013 Vs. Placebo in Subjects With Metastatic Malignant Melanoma Whose Disease Has Progressed on Treatment With DTIC, IL-2, or IFN Based Therapy

Conditions

MelanomaNeoplasm Metastasis

Study Type

Interventional

Study Design

Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Study Start

October 2002; Study completion: December 2004

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and above
• Genders Eligible for Study: Both

Inclusion Criteria:

• Understand and voluntarily sign an informed consent form
• Able to adhere to the study visit schedule and other protocol requirements
• Metastatic malignant melanoma now stage IV, relapsed or refractory to standard metastatic therapy
• Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of starting study drug
• Patients with active brain disease, or newly diagnosed brain metastases, within 4 weeks prior to the start of study treatment are excluded.

Total Enrolment

274

Contact Details

Australian Capital Territory

• The Canberra Hospital, Garran, Australian Capital Territory, 2605, Australia

New South Wales

• Sydney Cancer Centre, Camperdown, New South Wales, 2145, Australia
• Westmead Hospital, Westmead, New South Wales, 2145, Australia
• Royal Newcastle Hospital, Newcastle, New South Wales, 2300, Australia
• Royal Prince Alfred Hospital, Camperdown, New South Wales, 2050, Australia

Queensland

• Roayl Brisbane Hospital, Herston, Queensland, 4029, Australia
• Princess Alexandra Hospital, Woolloongabba, Queensland, 4102, Australia

South Australia

• Royal Adelaide Hospital, Adelaide, South Australia, 5000, Australia

Tasmania

• Royal Hobart Hospital, Hobart, Tasmania, 7001, Australia

Victoria

• Cabrini Hospital, Malvern, Victoria, 3144, Australia

Western Australia

• Sir Charles Gairdner Hospital, Nedlands, Western Australia, 6009, Australia
• Mount Hospital Oncology, Perth, Western Australia, 6009, Australia

Results of study