4 results
Main objective• To determine the safety and tolerability of multiple dosing of SPC3649Secondary objectives• To assess the pharmacokinetics (PK) of multiple dosing of SPC3649 administered by i.v. and s.c. route in healthy volunteers• To evaluate the…
To determine the effect of a high-fat meal on the exposure to docetaxel given as ModraDoc006 tablets in combination with ritonavir in patients with cancer.
1. Overall survival (primary efficacy endpoint)2a. Efficacy: progression-free survival (PFS), overall response rate (ORR = CR + PR), and a clincal benefit rate (CBR) will be evaluated as CR + PR + SD for at least 3 months.2b. Safety: adverse events…
The primary aim of this trial is to determine the recommended safe dose and schedule of ModraDoc006/r in castration-resistant prostate cancer (CRPC) patients. The first 5 CRPC patients in this study showed a different pharmacokinetic profile, as…