8 results
Primary objectives: To assess the ability of dabrafenib + trametinib treatment to downsize melanoma tumor masses to enable R0-resection. Secondary objectives: Recurrence free survival; time-to-next treatment, overall survival.
This study has been transitioned to CTIS with ID 2023-509318-13-00 check the CTIS register for the current data. This is an open-label, multi-center, roll-over study designed to provide continued access to subjects who have previously participated…
This study has been transitioned to CTIS with ID 2023-509276-42-00 check the CTIS register for the current data. Primary:To assess the long-term safety of treatment with dabrafenib, trametinib or the combination.Secondary:To assess the long-term…
Part 1 primary objectives: To determine the safety, tolerability and range of tolerated combination doses in subjects with BRAF-V600E mutation-positive CRC intwo dosing groups:* dabrafenib dosed orally in combination with panitumumab * trametinib…
Primary objective:To characterize safety and tolerability of each treatment arm tested and identify recommended doses (RD) and regimens for future studies, by assessing the incidence and severity of AEs and SAEs; including changes in laboratory…
Primary: efficacy of dabrafenib and trametinib combination therapy compared to placebo with respect to overall response rate in subjects with rare BRAF V600E mutated solid tumors or hematologic malignancies.Secondary: duration of response,…
Primary: overall response rate.Secondary: progression free survival, duration of response, overall survival, safety, tolerability, pharmacokinetics (PK).
This study has been transitioned to CTIS with ID 2024-516126-54-00 check the CTIS register for the current data. The main objective of this study is to study the feasibility and efficacy of neo-adjuvant treatment with BRAF/MEK inhibition to increase…