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Клинические исследования в Украине

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Исследования / № 00162123

Описание
Краткое названиеA Companion Study for Patients Enrolled in Prior/Parent Ipilimumab Studies
Полное названиеA Multi-Center, Open-Label, Phase II Study of Ipilimumab (MDX-010 Extended-Treatment Monotherapy or Follow-up for Patients Previously Enrolled in Ipilimumab (MDX-010) Protocols.
СпонсорBristol-Myers Squibb
Industry
ИсточникBristol-Myers Squibb
Под контролемUnited States: Food and Drug Administration
Yes
Краткое описаниеThe purpose of this study is to evaluate the continued use of ipilimumab in patients who had
clinical benefit in a prior/parent study and are now eligible to receive either Re-Induction
at the time of disease progression or to continue Maintenance treatment. In addition, this
study will also continue to follow patients that have had ipilimumab but who are not
eligible for Maintenance or Re-Induction therapy.
СостояниеАктивный, набор окончен
Дата началаMay 2006
ФазаPhase 2/Phase 3
Вид исследованияAllocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Набор0
КритерииInclusion Criteria:

- Diagnosis of advanced melanoma

- Prior treatment in a prior/parent ipilimumab study

- Men and women >=18 years of age (or, >=16, if allowable per local regulatory
authority)

Exclusion Criteria:

- Prior treatment with a CD137 agonist or CTLA-4 inhibitor or agonist, except for
ipilimumab

- Primary ocular or mucosal melanoma
ПолBoth
Минимальный возраст18 Years
Максимальный возрастN/A
УсловиеMelanoma
Применяемое лечение
DrugIpilimumab
DrugIpilimumab
Контакты и расположение
Dnepropetrovsk , 49044Local Institution
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