Print Download. The EU Clinical Trials Register currently displays clinical trials with a EudraCT protocol, of which are clinical trials conducted with subjects less than 18 years old. Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan PIP are not publicly available see Frequently Asked Questions.
Examples: Cancer AND drug name. Pneumonia AND sponsor name. How to search [pdf]. For these items you should use the filters and not add them to your search terms in the text field. Print Download Summary. Expand All Collapse All. Review by the Competent Authority or Ethics Committee in the country concerned. For support, Contact us. The status and protocol content of GB trials is no longer updated since 1 January EU Clinical Trials Register.
Search tools. Select Date Range: to. Select Rare Disease:. IMP with orphan designation in the indication. Orphan Designation Number:. Results Status: Trials with results Trials without results. Clear advanced search filters. Date on which this record was first entered in the EudraCT database:. View results. Title of the trial for lay people, in easily understood, i. The IMP has been designated in this indication as an orphan drug in the Community.
Committee on Advanced therapies CAT has issued a classification for this product. Combination product that includes a device, but does not involve an Advanced Therapy. Locally advanced or metastatic non-small-cell lung cancer.
Phase I: -Determine the safety profile and tolerability of S given in combination with a fixed dose of gefitinib by assessment of DLT assessed during cycle 1 and the adverse event profile assessed at each study visit. An interim analysis will be performed in each subgroup to stop the recruitment early for futility if it is clear that the association S and gefitinib is unlikely to show the expected benefit.
