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Клинические исследования в Украине

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Исследования / № 00501332

Описание
Краткое названиеEvaluation of Maxy-G34 in Breast Cancer Patients Treated With TAC (Docetaxel, Adriamycin, Cyclophosphamide) Chemotherapy
Полное названиеA Phase IIa, Open Label, Controlled, Dose Ranging Study of Maxy-G34 as an Adjunct to TAC Chemotherapy in High-Risk Patients With Stage I, II, or IIIa Breast Cancer.
СпонсорMaxygen Holdings Ltd.
Industry
ИсточникMaxygen Holdings Ltd.
Под контролемUnited States: Food and Drug Administration
Romania: National Medicines Agency
Poland: Ministry of Health
Ukraine: State Pharmacological Center - Ministry of Health
Russia: Ministry of Health and Social Development of the Russian Federation
Yes
Краткое описаниеThis is an investigation of the safety and efficacy of Maxy-G34 in breast cancer patients
treated with TAC chemotherapy. Maxy-G34 will be given as a single injection during each
cycle of chemotherapy, for a planned total of six chemotherapy cycles.
СостояниеИдет набор
Дата началаJuly 2007
ФазаPhase 2
Вид исследованияAllocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Набор0
КритерииKey Inclusion Criteria:

1. Males and females at least 18 years of age

2. Diagnosis of high-risk stage I, II or IIIa breast cancer suitable for adjuvant TAC
chemotherapy as based on investigator judgment

3. Candidates for TAC chemotherapy, and no prior treatment with anthracyclines

Key Exclusion Criteria:

1. Received chemotherapy within last 3 month prior to screening, or expected to receive
any chemotherapy other than TAC and / or immunotherapy between screening and 30 days
after last planned study drug administration

2. Any clinically significant findings on history or examination that, in the opinion of
the investigator, would preclude administration of TAC chemotherapy in the full dose,
including abnormal liver function, inadequate cardiac function or clinically
significant cardiac disease, neuropathy or other disease

3. Prior bone marrow or peripheral blood hematopoietic stem cell transplant

4. Any active cancer or history of prior malignancy within the last 5 years except
carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of
the skin or any surgically cured malignancy diagnosed 5 years or more before
diagnosis of breast cancer
ПолBoth
Минимальный возраст18 Years
Максимальный возрастN/A
УсловиеChemotherapy-Induced Neutropenia
Применяемое лечение
BiologicalMaxy-G34
Контакты и расположение
Dnipropetrovsk
Uzhorod
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