9 results
Primary: overall response rate.Secondary: progression free survival, duration of response, overall survival, safety, tolerability, pharmacokinetics (PK).
Primary: superiority of dabrafenib and trametinib combination therapy over dabrafenib and trametinib-placebo (dabrafenib monotherapy) with respect to progression-free survival (PFS) for subjects with advanced/metastatic BRAF V600E/K mutation-…
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.
Primary: To assess the effect of multiple doses of tasqinimod on the single-dose pharmacodynamics (PD) of warfarin. Secondary: To assess the effect of multiple doses of tasqinimod on the single-dose pharmacokinetics (PK) of warfarin. To assess the…
Primary : To assess the effect of multiple doses of rifampicin on the single-dose pharmacokinetics (PK) of tasquinimodSecondary : To assess the safety and tolerability of multiple doses of rifampicin with a single dose of tasquinimod
Primary:- To assess the effect of multiple doses of ketoconazole on the single-dose pharmacokinetics (PK) of tasquinimod.Secondary:- To assess the safety and tolerability of multiple doses of ketoconazole with single doses of tasquinimod.
To compare the efficacy and tolerability of a combination therapy with ursodeoxycholic acid (12-16 mg/kg body weight plus budesonide (9mg/d) vs. ursodeoxycholic acid (12-16 mg/kg BW/d) plus placebo in the treatment of PBC. To study safety and…
To demonstrate that a dose reduction of 20-33% of CYP3A4 metabolized tyrosine kinase inhibitors in patients expressing the CYP3A4*22 gene (rs35599367 C>T in intron 6) does not result in a lower exposure (Ctrough) than the wildtype group with…
* Safety Run inTo determine the recommended regimen of PDR001 in combination with dabrafenib and trametinib for the randomized part (part 3)* Biomarker cohortTo evaluate changes in the immune microenvironment and biomarker modulations upon treatment…