A Phase II, Open-label, Study in Subjects With BRAF V600E-Mutated Rare Cancers With Several Histologies to Investigate the Clinical Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib
Phase of Trial: Phase II
Latest Information Update: 08 Jan 2018
At a glance
- Drugs Dabrafenib (Primary) ; Trametinib (Primary)
- Indications Biliary cancer; Gastrointestinal stromal tumours; Germ cell and embryonal neoplasms; Glioma; Hairy cell leukaemia; Intestinal cancer; Multiple myeloma; Thyroid cancer
- Focus Therapeutic Use
- Acronyms ROAR
- Sponsors GlaxoSmithKline; Novartis; Novartis Pharma A.G.; Novartis Pharmaceuticals
- 02 Jan 2018 Planned End Date changed from 1 Aug 2019 to 3 Aug 2020.
- 02 Jan 2018 Planned primary completion date changed from 1 Jun 2019 to 29 Jun 2020.
- 26 Oct 2017 Interim analysis results (data cut-off:26 Aug 2016) assessing the efficacy and safety of dabrafenib and trametinib combination therapy in BRAF V600E-mutated anaplastic thyroid cancer patients (n=16) and safety analysis results in safety population including seven rare tumor histologies (n=100), published in the Journal of Clinical Oncology.