9 results
To investigate the influence of concomitant enzalutamide on the pharmacokinetics of cabazitaxel.
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 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.
Primary Objectives:• To assess the efficacy (progression free survival [PFS]) of DCC 2618 by independent radiologic review in patients with advanced gastrointestinal stromal tumors (GIST) who have received prior therapiesKey Secondary Objectives:•…
The primary objective is to investigate the efficacy of a single intradiscal injection of STA363 into one or two IVDs as compared to placebo by the following primary efficacy endpoint:* Change from baseline at Month 6 in mean pain intensity measured…
To determine the influence of darolutamide on the pharmacokinetics of cabazitaxel compared to cabazitaxel alone in mCRPC patients.
Escalation PhasePrimary ObjectivesThe primary objectives of this study are to:• Determine the safety and tolerability of oral DCC-2618• Determine a maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of oral DCC-261Secondary…
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…