A Phase 3 Study of Nilotinib versus Imatinib in GIST Patients
Research type
Research Study
Full title
A randomized, multi-center phase III study to evaluate the efficacy and safety of nilotinib versus imatinib in adult patients with unresectable or metastatic gastrointestinal stromal tumours (GIST)
IRAS ID
4443
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2008-004758-34
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to see whether a new drug, Nilotinib, is an effective treatment for people with gastrointestinal stromal tumours (GIST). This study will compare the effectiveness of Nilotinib with Imatinib, a standard therapy for GIST. Nilotinib works is a similar way to Imatinib. Nilotinib has been shown to be effective in laboratory studies and has also shown effectiveness in a small clinical study in patients with GIST, including those whose disease was resistant to Imatinib. Patients will receive either Nilotinib or Imatinib on a daily basis. This is an open label study, which means that both the patient and the doctor will know which medication the patient is taking. Patients will visit the study hospital every three months for routine check-ups and CT scans. The study will consist of two parts; a core study followed by an extension study, where patients will be offered alternative study treatment if the original treatment is not working. After treatment, there will be a follow-up period. Each participant will take part for up to 10 years. Approximately 736 patients will take part in this study in over 30 countries in Europe, Asia, North and South America, Africa and Australia. This study is being organised by Novartis Pharma Services AG of Lichstrasse 35, 4056 Basel, Switzerland.
REC name
London - Hampstead Research Ethics Committee
REC reference
09/H0720/23
Date of REC Opinion
12 Mar 2009
REC opinion
Further Information Favourable Opinion