10 results
The primary hypothesis of this study is that ibrutinib compared with temsirolimus significantly prolongs PFS in subjects with relapsed or refractory MCL who have received at least 1 prior rituximab-containing chemotherapy regimen.
* The primary objective of this study is to investigate the effect of rifampicin on the pharmacokinetics (PK) of olaparib following oral dosing of the tablet formulation in patients with advanced solid tumours.* The secondary objectives are to…
To study the effect of alleviation of obstructive cholestasis by biliary drainage with or without rifampicin on serum bilirubin levels, quality of life, itch intensity, and serum and/or biliary bile salt, ATX, LPA, FGF-19 and biliary HCO3- levels in…
Primary: • Demonstrate superior efficacy (increased progression-free survival [PFS]) of MEK162 vs. physician*s choice of selected chemotherapies (liposomal doxorubicin, paclitaxel and topotecan)Key Secondary: • Demonstrate superior efficacy (…
OBJECTIVES of the Study:Primary ObjectiveTo evaluate if the addition of ibrutinib to R-CHOP prolongs event-free survival (EFS) compared withR-CHOP alone in subjects with newly diagnosed non-GCB DLBCL.Secondary ObjectivesTo compare ibrutinib in…
To determine whether treatment with MEK162 prolongs PFS as compared to dacarbazine in patients with previously untreated, advanced unresectable, or metastatic NRAS mutation-positive melanoma who are previously untreated or who have progressed on or…
The primary objectives of the study are to characterize the safety and toxicity profiles of epcoritamab when co-administered with anti-neoplastic agents in subjects with B-cell NHL and to determine the recommended dose for further investigation of…
Primary ObjectiveThe primary objective of this study is to evaluate whether the addition of ibrutinib to bendamustine and rituximab will result in prolongation of PFS in subjects with newly diagnosed MCL who are 65 years of age or older.Secondary…
PRIMARY: Dose finding part (Phase 1):To assess the safety and tolerability of durvalumab when given in combination with lenalidomide and rituximab; ibrutinib; or bendamustine and rituximab to determine the recommended Phase 2 doses (RP2Ds) of each…
Part A - Dose Finding/SafetyPrimary Objective:* To determine the recommended pediatric equivalent dose (RPED; based on pharmacokinetic [PK] and, if applicable,pharmacodynamic data) for use in pediatric subjects (age >=1 to <12 years)…