Клинические исследования в Украине

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Краткое названиеStudy Evaluating SKI-606 (Bosutinib) In Subjects With Breast Cancer
Полное названиеPhase II Study Of SKI-606 In Subjects With Advanced Or Metastatic Breast Cancer
Под контролемUnited States: Food and Drug Administration
Краткое описаниеThe purpose of this study is to determine if SKI-606 (Bosutinib) is effective in the
treatment of advanced or metastatic breast cancer. Patients must have current Stage IIIB,
IIIC or IV breast cancer and have progressed after 1 to 3 prior chemotherapy regimens.
Дата началаApril 2006
ФазаPhase 2
Вид исследованияAllocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
КритерииInclusion Criteria:

- Stage IIIB, IIIC or IV breast cancer not curable with available therapy.

- Patients must have progressed after 1 but not more than 3 prior chemotherapy

- Life expectancy of at least 16 weeks.

- Ability to swallow whole capsules.

Exclusion Criteria:

- Use of or requirement for bisphosphonates within 8 weeks prior to screening.

- Any other cancer within 5 years of screening, except for basal cell carcinoma or
cervical carcinoma in situ

- Uncontrolled cardiac disease including congestive heart failure, angina, heart
attack, etc.

- Recent or ongoing significant gastrointestinal disorder
Минимальный возраст18 Years
Максимальный возрастN/A
УсловиеBreast Neoplasms
Применяемое лечение
DrugSKI-606 (Bosutinib)
Контакты и расположение
Dnipropetrovsk , 49102Pfizer Investigational Site
Sumy , 40005Pfizer Investigational Site
Uzhgorod , 88014Pfizer Investigational Site
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