WHO ICTRP trial

The aim of this study is to see how well an investigational drug (called…

EUCTR2016-002718-32-IT · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2016-002718-32-IT
Public title The aim of this study is to see how well an investigational drug (called BBI-608) works when it is given in combination with paclitaxel, a chemotherapy treatment, or if it is better to receive paclitaxel alone for people with advanced, previously treated lung cancer. To do so, half of the patients in this study will receive paclitaxel plus BBI-608 while the other half will receive paclitaxel alone.
Scientific title A Phase III Randomized, Open-Label Clinical Trial of BBI-608 plus Weekly Paclitaxel versus Weekly Paclitaxel Alone in Patients with Advanced, Previously Treated, Non-Squamous Non-Small Cell Lung Cancer - -
Primary sponsor BOSTON BIOMEDICAL, INC.
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries United States;Czechia;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Germany;China;Japan;Korea, Republic of
Conditions Histologically or cytologically confirmed recurrent, locally advanced, or metastatic non-squamous non-small cell lung cancer. MedDRA version: 21.1 Level: LLT Classification code 10066490 Term: Progression of non-small cell lung cancer…
Interventions Product Name: BBI-608 (napabucasin) Product Code: BBI-608 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Napabucasin CAS Number: 83280-65-3 Current Sponsor code: - Other descriptive name: NAPABUCASIN, BBI-608, BBI608, BB608…
Registration date Jan 20, 2021
Target size 870
Secondary IDs CanStem43L;NCT02826161;2016-002718-32-ES
Registry page clinicaltrialsregister.eu

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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date:

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