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Краткое названиеA Phase 1/2 Study of HKI-272 (Neratinib) in Combination With Paclitaxel (Taxol) in Subjects With Solid Tumors and Breast Cancer
Полное названиеA Phase 1/2 Study of HKI-272 in Combination With Paclitaxel in Subjects With Solid Tumors and Breast Cancer
СпонсорWyeth
Industry
ИсточникWyeth
Под контролемUnited States: Food and Drug Administration
No
Краткое описаниеThe purpose of this study is to learn whether it is safe and effective to administer HKI-272
(neratinib) in combination with paclitaxel in patients with breast cancer.
СостояниеАктивный, набор окончен
Дата началаSeptember 2007
ФазаPhase 1/Phase 2
Подробное описаниеThe study will be conducted in two parts. In the first part, testing will be done to
determine the highest tolerable dose of HKI-272 and Paclitaxel in patients with advanced
solid tumors.

In the second part of the study, subjects with breast cancer will be enrolled to further
test the safety of the drug combination, and to obtain preliminary data on the efficacy of
the combination.
Вид исследованияAllocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Набор0
КритерииInclusion Criteria:

Inclusion criteria for both parts of clinical trial:

- Good performance status

- Normal ejection fraction

- Adequate cardiac, kidney, and liver function

- Adequate blood counts

- At least one measurable target lesion

- Negative pregnancy test for female subjects

Inclusion Criteria for Part 1 Only:

- Pathologically confirmed solid tumor not curable with available standard therapy

Inclusion Criteria for Part 2 Only:

- Pathologically confirmed breast cancer

- HER2 positive tumor

- Prior treatment with Herceptin

Exclusion Criteria:

Exclusion criteria for both parts of clinical trial:

- Major surgery, radiotherapy, chemotherapy or investigational agents within two weeks
of treatment day 1

- Subjects with bone or skin as the only site of disease

- Active central nervous system metastases

- Significant cardiac disease or dysfunction

- Significant gastrointestinal disorder

- Inability or unwillingness to swallow HKI-272 capsules

- Prior exposure to HKI-272 or other HER2 targeted agents, except trastuzumab (Part 2
only). Prior lapatinib is permitted in arm B of part 2.

- Treatment with a taxane within 3 months of treatment day 1

- Grade 2 or greater motor or sensory neuropathy

- Pregnant or breast feeding women

- Known hypersensitivity to paclitaxel or Cremophor EL

- Prior treatment with anthracyclines with cumulative dose of >400 mg/m^2

- Any other cancer within 5 years with the exception of contralateral breast cancer,
adequately treated cervical carcinoma in situ, or adequately treated basal or
squamous cell carcinoma of the skin

Exclusion Criteria for Part 2 Only:

- More than 1 (arm A) or 3 (arm B) prior cytotoxic chemotherapy regimen for metastatic
disease
ПолBoth
Минимальный возраст18 Years
Максимальный возрастN/A
УсловиеAdvanced Breast Cancer
Применяемое лечение
DrugCombination of HKI-272 (neratinib) and paclitaxel
DrugCombination of HKI-272 and paclitaxel
DrugCombination of HKI-272 (neratinib) and paclitaxel
DrugCombination of HKI-272 (neratinib) and paclitaxel
Контакты и расположение
Dnepropetrovsk , 49102Pfizer Investigational Site
Lvov , 79031Pfizer Investigational Site
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