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Активно (без набиране) Фаза 3 NCT01933932

Assess Efficacy & Safety of Selumetinib in Combination With Docetaxel in Patients Receiving 2nd Line Treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Positive NSCLC

Фаза 3 – широко изпитване преди одобрение
Заболявания: Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV

Спонсор: AstraZeneca

Налично на: БГ
Обобщение
The purpose of this study is to assess the efficacy of selumetinib in combination with docetaxel (75mg/m2) vs placebo in combination with docetaxel (75mg/m2) in patients with locally advance or metastatic NSCLCs that harbor mutations of KRAS. This study will also assess the PK, safety, patient reported outcomes (PRO) and tolerability profile of the selumetinib/docetaxel combination, compared to placebo in combination with docetaxel
Описание
A Phase III, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination with Docetaxel, in Patients receiving second line treatment for KRAS Mutation-Positive Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV) (SELECT-1)
Кой може да участва
Inclusion Criteria: * Provision of signed, written and dated informed consent prior to any study specific procedures * Male or female, aged 18 years or older * Histological or cytological confirmation of locally advanced or metastatic NSCLC (IIIB-IV) * KRAS mutation positive tumour sample as determined by the designated testing laboratory * Failure of 1st line anti-cancer therapy due to radiological documentation of disease progression in advanced disease or subsequent relapse of disease following 1st line therapy Exclusion Criteria: * Mixed small cell and non-small cell lung cancer histology. * Received \>1 prior anti-cancer drug regimen for advanced or metastatic NSCLC. Patients who develop disease progression while on switch maintenance therapy (maintenance using an agent not in the first-line regimen) will not be eligible. * Receiving or have received systemic anti-cancer therapy within 30 days prior to starting study treatment * Other concomitant anti-cancer therapy agents excepts steroids * Prior treatment with a Mitogen-Activated protein Kinase (MEK) inhibitor or any docetaxel-containing regimen (prior treatment with paclitaxel is acceptable). * Last radiation therapy within 4 weeks prior starting study treatment, or limited field of radiation for palliation within 7 days of the first dose of study treatment
Места на провеждане 24
Argentina (1)
Research Site
Buenos Aires
Австралия (1)
Research Site
Camperdown
Белгия (1)
Research Site
Brussels
Бразилия (1)
Research Site
Barretos
България (1)
Research Site
Plovdiv
Канада (1)
Research Site
Edmonton , Alberta
Chile (1)
Research Site
Santiago
Франция (1)
Research Site
Brest
Германия (1)
Research Site
Augsburg
Унгария (1)
Research Site
Budapest
Израел (1)
Research Site
Beersheba
Италия (1)
Research Site
Bari
Mexico (1)
Research Site
México
Нидерландия (1)
Research Site
's-Hertogenbosch
Peru (1)
Research Site
Lima
Полша (1)
Research Site
Brzozów
Румъния (1)
Research Site
Cluj-Napoca
Russia (1)
Research Site
Kazan'
Испания (1)
Research Site
Barcelona
Швеция (1)
Research Site
Linköping
Турция (1)
Research Site
Ankara
Ukraine (1)
Research Site
Chernivtsі
Великобритания (1)
Research Site
Aberdeen
САЩ (1)
Research Site
Aurora , Colorado
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
130 Years
Здрави доброволци
Не
Начална дата
25.09.2013
Крайна дата
31.12.2025
Регистрационен номер
NCT01933932
Източник
anzctr
Запитване за медицински туризъм

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