DESCRIBEIII: Retrospective Chart Review for Patients in IPP
Research type
Research Study
Full title
Describe III: Retrospective chart review of dabrafenib monotherapy and/or dabrafenib-trametinib combination therapy in patients with metastatic melanoma to characterize patients with long term benefit in the Individual Patient Program (IPP).
IRAS ID
230834
Contact name
Mazhar Ajaz
Contact email
Sponsor organisation
Novartis Pharmaceuticals UK Limited
Duration of Study in the UK
0 years, 6 months, 29 days
Research summary
The DESCRIBE III study will gather data on patients who have been part of Novartis’ Named Patient Program\ GSK’s Individual Patient Program. The patients that are recruited into this study will either have received Dabrafenib as monotherapy or Dabrafenib/Trametinib as a combination therapy. The patients will be divided into three treatment benefit groups. Long-term benefit (on therapy ≥ 12 months), Intermediate duration benefit (on therapy ≥ 6 and <12 months), and Short-term benefit (on therapy < 6 months). As this study will be observational in nature, it does not impose any therapy or diagnostic/therapeutic interventions. No patient-identifying information will be collected. Each identified patient will be assigned a pre-formatted unique study identification number.
The study will take place across 14 countries in 59 sites. The data collected will include Baseline Characteristics, Disease Progression, Treatment Patterns, Safety and Survival Status. It is estimated that in excess of 600 patient charts will be used in this study.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
17/WM/0392
Date of REC Opinion
16 Oct 2017
REC opinion
Favourable Opinion