22 results
The purpose of this phase I/II is to characterize the safety, tolerability, preliminary activity, pharmacokinetic (PK) and pharmacodynamics (PD) profile of TKI258 administered orally on a 5 days on/2 days off dosing schedule in adult patients with…
Primary:Dual-agent dose escalation part (Part 1):• To determine the maximum tolerated dose of oral, daily (qd) BEZ235 in combination with paclitaxel, qw in patients with advanced solid tumors(MTD1, Arm 1).• To determine the maximum tolerated dose of…
The primary objective of this study is to investigate the effect of food on the pharmacokinetics (PK) of olaparib following oral dosing of the capsule formulation in patients with advanced solid tumours.The secondary objective is to further…
The primary objective of this study is to investigate the effect of food on the pharmacokinetics(PK) of olaparib following oral dosing of the tablet formulation in patients with advancedsolid tumours.The secondary objectives are to investigate the…
-The primary objective of this study is to investigate the pharmacokinetics of olaparib after a single oral dose of 300 mg to patients with advanced solid tumours and mild or moderate renal impairment compared to those with normal renal function.-…
* 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…
The primary objective of this study is to investigate the effect of itraconazole on thepharmacokinetics (PK) of olaparib following oral dosing of the tablet formulation inpatients with advanced solid tumours.The secondary objectives are: to…
PrimaryTo assess the safety and tolerability of olaparib when given in addition to abiraterone and torecommend, by assessment of dose-limiting toxicities and other safety and tolerability data, adose of olaparib for further study when given in…
Primary objective: To estimate the MTD/RDE of LOP628 in solid tumors and AML, respectively.Secondary objectivesL:- To characterize the safety and tolerability of LOP628- To characterize the pharmacokinetic profile of LOP628- To assess emergence of…
-The primary objective of this study is to investigate the pharmacokinetics (PK) of olaparib after a single oral dose of 300 mg to patients with advanced solid tumours and mild or moderate hepatic impairment compared to those with normal hepatic…
Primary: Phase Ib: To estimate the MTD(s) and/or RP2D(s) of the triple combination of WNT974, LGX818 andcetuximab in patients with BRAFV600-mutant CRC harboring Wnt pathway mutations.Phase II: To estimate the preliminary anti-tumor activity of the…
Primary: To estimate the MTD and/or RDE for each of the following three treatment arms in patients with myelofibrosis.* PIM447 plus ruxolitinib (doublet)* Ribociclib (LEE011) plus ruxolitinib (doublet)* PIM447 plus ruxolitinib and Ribociclib (LEE011…
Primary: Phase I: - To characterize the safety and tolerability of MBG453 as a single agent and in combination with PDR001 and to identify recommended doses for future studies. To further investigate the safety and tolerability of different doses of…
Secondary objectiveTo assess the safety and tolerability of the investigational treatments in patients with moderate to severe hidradenitis suppurativa (HS) by:• Number and severity of AEs • Physical examination, vital signs, safety laboratory…
Primary:To compare the efficacy of olaparib when given in addition to abiraterone, with placebo givenin addition to abiraterone, by assessment of radiologic progression-free survival (rPFS) usingResponse Evaluation Criteria in Solid Tumours version…
Primary: To determine the maximum tolerated dose (MTD) and thus the recommended phase IIdose and schedule of single agent oral BGJ398 in patients with advanced solid tumors with FGFR1 or FGFR2 amplification or FGFR3 mutation.Secundary objectives* to…
Primary: Phase 1: To estimate the RP2D and/or the MTD for PDR001.Phase II: To estimate the anti-tumor activity of PDR001.Secondary: Both phases: Safety and tolerability, PK profile, emergence of anti-PDR001 antibodies, other parameters for…
Primary: Part 1: Safety and tolerability. Determine the MTD and/or RP2D of MAK683.Part 2: Anti-tumor activity of MAK683.Secondary: Part 1: Anti-tumor activity. Pharmacodynamics (PD). Pharmacokinetics (PK).Part 2: Safety and tolerability. PK, PD.
Primary: • Part 1:To evaluate the efficacy of NIR178 and PDR001 combination in patients with selected advanced solid tumors and diffuse large B cell lymphoma (DLBCL). • Part 2: To assess the efficacy of several intermittent dosing schedules of…
To assess the effect of MEDI4736 in combination with olaparib±bevacizumab in patients with selected advanced solid tumors.To assess the safety and tolerability of MEDI4736 in combination with olaparib (±bevacizumab) in patients with selected…