7 results
The overall objective of this phase I/II three-part study is to evaluate the benefit of 12 weeks once daily dosing with ASP9521 in a population of patients with metastatic castrate resistant prostate cancer (CRPC) who have failed one or more lines…
The objective of this pivotal study is to assess the PK and PD as well as safety and tolerability of RP103 compared to Cystagon® in patients with nephropathic cystinosis. Results of this Phase 3 study will be used to support the registration…
- To assess the pharmacokinetic profile of cysteamine base after single dose administration of the new sustained-release cysteamine bitartrate (PO-001) to healthy volunteers, in comparison with Cystagon® and Procysbi®.- To collect safety/…
Primary:* Phase 1b:o Determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of binimetinib administered in combination with nivolumabo Determine the MTD and RP2D of binimetinib administered in combination with nivolumab plus…
Safety Lead-inIn patients with BRAF V600E mutant (BRAFV600E) metastatic colorectal cancer (mCRC):Primary: • Assess the safety/tolerability of the combination of encorafenib + binimetinib + cetuximabSecondary:• Assess the activity of encorafenib +…
To assess the anti-tumor activity of LGX818/MEK162 in combination with third targeted agents after progression on LGX818/MEK162 combination therapy.
The primary objective is to prospectively assess whether a sequential approach with an induction period of 12 weeks with encorafenib + binimetinib followed by an immunotherapy combination with nivolumab + ipilimumab improves Progression Free…