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Описание
Краткое названиеOral Topotecan Versus Intravenous Docetaxel In Pretreated, Advanced Non-Small Cell Lung Cancer
Полное названиеAn Open-Label, Multicentre, Randomised, Phase III Study Comparing Oral Topotecan to Intravenous Docetaxel in Patients With Pretreated Advanced Non Small Cell Lung Cancer
СпонсорGlaxoSmithKline
Industry
ИсточникGlaxoSmithKline
Под контролемUnited States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Краткое описаниеThe purpose of this study is to collect information on how effective and how well tolerated
an oral investigational drug is compared to a standard intravenous drug in patients with
pretreated, advanced non-small lung cancer (NSCLC).
СостояниеЗавершено
Дата началаOctober 2001
ФазаPhase 3
Вид исследованияAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Набор760
КритерииInclusion Criteria:

- Written informed consent

- Patients with advanced non-small cell lung cancer (NSCLC).

- Patients who have received one previous chemotherapy for NSCLC.

- Full recovery from previous chemotherapy.

- Presence of either measurable or non-measurable disease by radiologic study or
physical examination.

- At least 3 weeks since last major surgery (a lesser period is acceptable if deemed in
the best interest of the patient).

- At least 24 hours since prior radiotherapy providing that marked bone marrow
suppression is NOT expected. Patients who have received radiotherapy must have
recovered from any reversible side effects (e.g. nausea and vomiting).

- Laboratory criteria: Patients must have adequate bone marrow reserve and adequate
kidney and liver function.

Exclusion Criteria:

- Symptoms of brain metastasis (cancer spreading to the brain), requiring treatment
with steroids.

- Active infection.

- Severe medical problems other than the diagnosis of NSCLC, that would limit the
ability of the patient to follow study guidelines or expose the patient to extreme
risk.

- Ongoing or planned chemotherapy, immunotherapy, radiotherapy, or investigational
therapy for the treatment of NSCLC.

- Use of investigational drug within 30 days prior to the first dose of study
medication.

- Women who are pregnant or lactating.

- Patients of child-bearing potential refusing to practice adequate birth control
methods.

- Patients with conditions which might alter absorption of an oral drug.
ПолBoth
Минимальный возраст18 Years
Максимальный возрастN/A
УсловиеNon-Small-Cell Lung Cancer
Применяемое лечение
Drugtopotecan
Контакты и расположение
Kharkov GSK Investigational Site
Lugansk GSK Investigational Site
Lvov , 79031GSK Investigational Site
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