16 results
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 objective: To demonstrate that QVA149 (110/50 *g o.d.) is superior to NVA237 (50 *g o.d.) with regard to the rate of moderate to severe COPD exacerbations during 64 weeks of treatmentSecondary objectives: To demonstrate that QVA149 (110/50 *…
Primary objectiveTo evaluate the relationship of incremental doses of NVA237 q.d. and b.i.d. and their effect on trough FEV1 after 28 days of treatment, as defined by the percentage of the maximal effect that each dose achieves in relation to the…
Primary objectivesTo confirm that NVA237 50µg o.d. (delivered via a SDDPI) vs. placebo significantly increases trough FEV1 (defined as mean evaluation at 23 h 15 min and 23 h 45 min post dose) following 12 weeks of treatment in patients with…
Primary objective: To demonstrate the superiority of QVA 110/50 µg compared to both QAB149 150 µg and NVA237 50 µg in terms of trough FEV1 (mean of 23 h 15 min and 23 h 45 min post-dose) following 26 weeks of treatment in patients with moderate to…
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 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…
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…
To investigate the influence of concomitant enzalutamide on the pharmacokinetics of cabazitaxel.
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…
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 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 Objective: Examine the accuracy of generated temperature values with three devices (Exergen, Braun and Genius) in concordance to rectal temperature in patients admitted to the Emergency Department (ED). Secondary Objective: Recommend the…
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…