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Клинические исследования в Украине

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Исследования / № 00057616

Описание
Краткое названиеStudy to Compare the Efficacy and Safety of CC-5013 Vs. Placebo in Subjects With Metastatic Malignant Melanoma.
Полное названиеMulticenter, 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
СпонсорCelgene Corporation
Industry
ИсточникCelgene Corporation
Под контролемUnited States: Food and Drug Administration
Краткое описаниеSubjects 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.
СостояниеЗавершено
Дата началаOctober 2002
ФазаPhase 3
Вид исследованияAllocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Набор274
Критерии- 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.
ПолBoth
Минимальный возраст18 Years
Максимальный возрастN/A
УсловиеMelanoma
Применяемое лечение
DrugCC-5013
Контакты и расположение
Dnipropetrovsk Dnipropetrovsk State Medical Academy
Kharkov , 61070Kharkov Postgraduate Medical Academy, Kharkov Regional Clinical Oncology Center
Kiev , 03022Scientific Research Institute of OncologySoft Tissue Department
Kiev , 3115Kiev City Oncology Hospital
Lviv , 79010Lviv State Medical University Regional Oncology Centre
Odessa , 65055Odessa Regional Oncology DispensaryChemotherapy Dept
Uzhgorod , 88000Uzhgorod Regional Oncology Diepensary
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