20 results
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…
To assess the analgesic effect of ARA290 in chronic pain patients
In this study we will assess the effect of ARA290 on nerve damage by taking 4 skin bipsies during treatment.
To investigate the influence of concomitant enzalutamide on the pharmacokinetics of cabazitaxel.
To study the effects of ARA290 on the cognitive and neural processing of emotions in healthy volunteers 7 days post-administration.
(1) To assess the effect of ARA 290 on the ventilatory response to hypoxia (and compare the effects to Epo); (2) To assess the effect of ARA 290 on the gradient over the tricuspid valve during hypoxia (and compare the effects to Epo); (3) To assess…
To measure the PK of ARA290 when given in de SQ form
This is an open label proof of principle study, in 14 patients. The objective of the study is to test the efficacy and safety of ARA 290 in patients with active rheumatoid arthritis. To assess the efficacy, disease activity is examined based on…
To measure the plasma conc. of ARA 290 in healthy volunteers
ARA290 is a new drug against neuropathic pain and was succesfully tested in previous studies on patients with neuropathic pain due to diabetes and sarcoidosis. The current study involves sarcoidosis patients with pain due to neuropathy. The purpose…
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…
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 Objective:The primary objective is to determine the safety, tolerability, dose-limiting toxicities (DLTs), and MTD/MAD/alternate dose of BMS-986156 administered alone and in combination with nivolumab in subjects with advanced solid tumors.…
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.
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…
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 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…
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…