18 results
1. Primary objective:To evaluate the efficacy of prucalopride versus placebo over 12 weeks of treatment in subjects aged 18 years and older with chronic non-cancer pain, suffering from OIC.2. Secondary objectives:To assess the safety and…
Main Objective:Phase II part: Efficacy of cabazitaxel compared to vinflunine in terms of improved objective response rate (ORR) of subjects with metastatic or locally advanced previously treated TCCU.Phase III part: Efficacy of cabazitaxel compared…
Primary: To evaluate the efficacy of prucalopride versus placebo over 12 weeks of treatment in male subjects with chronic constipation.Secondary: To evaluate the safety, tolerability, effect on quality of life and effect on symptoms of prucalopride…
To investigate the influence of concomitant enzalutamide on the pharmacokinetics of cabazitaxel.
To asses the effect of Prucalopride on esophageal contraction characteristics and lower esophageal sphincter pressure, gastric emptying and esophageal reflux parameters in healthy male subjects
The primary objective is to evaluate the efficacy of prucalopride compared to placebo for the treatment of functional constipation in a paediatric population, aged *6 months to <18 years. Secondary objectives include:1. Investigation of the…
To evaluate the overall safety and tolerability of intrathecally administered single ascending bolus doses of Xen2174 in healthy subjectsTo evaluate the effects of Xen2174, following its administration as a single intrathecal bolus, on EEG activity…
The objectives of the study are:To determine the pharmacokinetic profile of Xen2174 in plasma and CSF when administered intrathecally to healthy volunteersTo determine which modalities of pain are affected by treatment with Xen2174 when administered…
The objectives of the study are:To determine the pharmacokinetic and pharmacodynamic interaction of a single ascending dose of Xen2174 with bupivacaine, and in one cohort of Xen2174 alone, when administered intrathecally to healthy volunteers and…
Primary objective: To assess the potential effect on QTcF interval (QTc Fridericia) of cabazitaxel in cancer patientsSecondary objectives:• To assess the effects of cabazitaxel on heart rate (HR), QT, QTcB (Bazett*s correction), and QTcN (population…
The main objective is to determine whether cabazitaxel or prolonged infusional ifosfamide demonstrate sufficient antitumor activity (as measured by progression free survival at 12 weeks) in pre-treated patients with metastatic or inoperable locally…
The primary objective of this study is to explore the PSA response rate to cabazitaxel in mCRPC patients who have progressed to docetaxel and to correlate the PSA response to AR-V7 expression in CTCs. Exploratory objectives include documenting the…
The main objective is to determine whether cabazitaxel demonstrates sufficient antitumor activity (as measured by progression free survival at 12 weeks) in pre-treated patients with metastatic or inoperable locally advanced DD liposarcoma to justify…
Primary objectives:To establish a safe and effective dosing schedule for repeated administration of Rhenium-188 HEDP combined with Cabazitaxel in order to proceed with a Randomised Phase 2 trial designed to determine the clinical value of Rhenium-…
The primary objective of this study is to explore the PSA response to cabazitaxel in mCRPC patients who have progressed to docetaxel and have detectable AR-V7 expression in CTCs. Exploratory objectives include describing the toxicity of cabazitaxel…
The aim of this phase IVI, randomized, open-label study is to compare the efficacy of cabazitaxel versus an AR targeted agent, in patients previously treated with docetaxel and likely to have primary resistance to AR targeted agents.
To determine the influence of darolutamide on the pharmacokinetics of cabazitaxel compared to cabazitaxel alone in mCRPC patients.
Primary: * To assess Clinical Benefit Rate (CBR) in patients with mCRPC and poor prognostic factors treated with cabazitaxel or novel hormonal agents (abiraterone OR enzalutamide) as second-line therapy.Secondary: * To formally compare CBR in both…