27 results
The purpose of this study is to evaluate the efficacy and safety of MDV3100, a novel potent androgen-receptor antagonist without known agonist activity, in asymptomatic or mildly symptomatic patients with progressive metastatic prostate cancer who…
The primary objective of the study is to determine the MTD (Maximally Tolerated Dose) of SGN-40 from among three possible dose levels when combined with a standard dose of bortezomib and to determine the safety and adverse event profile for…
The primary objectives of the study are:- to establish the optimal dose of the combination for second-line therapy with NAMI-A and Gemcitabine (Phase I part)- to assess the response rate according to RECIST criteria (Phase II part) in advanced NSCLC…
To assess safety, tolerability and activity of nelfinavir given neo-adjuvant and concomitant to chemoradiotherapy with temozolomide in patients with a newly diagnosed glioblastoma multiforme. To describe the possible effect of nelfinavir on…
1) To compare pembrolizumab plus enzalutamide versus placebo plus enzalutamide with respect to overall survival (OS)2) To compare pembrolizumab plus enzalutamide versus placebo plus enzalutamide with respect to radiographic progression-free survival…
Primary Objective- To determine the benefit of enzalutamide plus ADT as compared to placebo plus ADT as assessed by radiographic progression-free survival (rPFS) based on central reviewMain Secondary Objectives- To determine the benefit of…
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…
Primary:Part A: To assess the safety and tolerability of single ascending doses of DMT in healthy subjects, when given by IV infusion. Part B: To assess the safety and tolerability of fixed repeated doses of DMT in healthy subjects, when given three…
Dose Expansion:Primary Objective-*To investigate the antitumor activity of HE3-DXdSecondary Objectives-*To assess the safety and tolerability of HE3-DXd in metastatic or unresectable NSCLC subjects-*To characterize the PK of HE3-DXd, total anti-HER3…
Primary objective - To assess the efficacy of q4w x3 i.a. injections of LRX712 in restoring the morphometrics of articular cartilage in the medial femoral condyleSecondary objectives- To evaluate LRX712 and metabolite MAE344 pharmacokinetics in…
1) Objective: To evaluate the safety and tolerability of the pembrolizumab combination therapy.2) Objective: To estimate PSA response rate of the pembrolizumab combination therapy. PSA response is defined as a reduction in the PSA level of 50% or…
Primary objectivePart 1: To investigate whether sTHC is released from a new chewing gum formulation.Part 2: To investigate the bioavailability of THC from chewing gum using dronabinol capsules as comparator in healthy male and female subjects.…
To evaluate the effect of AZD4831 as compared to placebo on the time to first COPDCompEx event in participants with moderate to severe COPD.
The objective of this study is to evaluate the effect of enzalutamide on morphine and edoxaban pharmacokinetics. This information is urgently needed to optimize the treatment of patients with prostate cancer using enzalutamide and facilitate the…
The primary objective is to determine the safety, tolerability, dose-limiting toxicities (DLTs), and maximum tolerated dose (MTD) of BMS-986016 administered alone and in combination with nivolumab in subjects with advanced solid tumors.The co-…
Primary objectiveTo demonstrate that talazoparib in combination with enzalutamide is superior to placebo in combination with enzalutamide in prolonging investigator--assessed Radiographic Progression-free Survival (rPFS), in participants with mCSPC…
The purpose of this research study is to learn about the safety and effectiveness of 177Lu-PNT2002, an investigational agent being studied for patients with mCRPC who have experienced disease progression following treatment with abiraterone,…
Primary:•To compare the effect of venglustat with standard of care Fabry therapies on left ventricular mass index over 18 months in participants with Fabry disease and left ventricular hypertrophySecondary:•To evaluate the effect of venglustat on…
Primary objective: To evaluate the efficacy of inebilizumab in reducing the risk of a disease flare in patients with IgG4-RD.Secondary objectives:• To evaluate the safety and tolerability of inebilizumab in patients with IgG4-RD.• To evaluate the…
Primary objectivePhase I: To determine the recommended phase II dose (RP2D) of the combination treatment with nivolumab and entinostat administered to adolescents 12-21 years with progressive, relapsed , refractory high-risk solid tumors and CNS…