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Pharmacogenetics of Mitotane

Primary objective:We hypothesize that genetic variability influences mitotane pharmacokinetics. Therefore our aim is to explore the inter-individual differences in genes coding for drug metabolizing enzymes in patients treated with mitotane and to…

Pharmacokinetic modeling of mitotane

The main objective of this study is to construct a population-pharmacokinetic model, in order to evaluate the influence of patient characteristics on the pharmacokinetics of mitotane in patients treated with this oral therapy.

Pheochromocytoma randomised study comparing adrenoreceptor Inhibiting
agents for preoperative treatment (PRESCRIPT)

The primary objective is to determine which of two commonly used drugs for preoperative management provides the best intraoperative hemodynamic control in patients undergoing resection of a PCC. Secondary Objective(s): o to identify other…

A phase 1/2 trial of EO2401, a novel microbial-derived peptide therapeutic vaccine, in combination with PD-1 check point blockade, for treatment of patients with locally advanced or metastatic adrenocortical carcinoma, or malignant pheochromocytoma/paraganglioma

The objective of this trial is to evaluate safety and tolerability of an experimental drug, EO2401, in combination with another immunological treatment, nivolumab, in patients with advanced or metastatic ACC and progressive MPP.

Novel treatment of adrenal crisis: an early clinical trial with nebulized prednisolone

The aim of this study is to establish pharmacokinetic data on inhaled nebulized prednisolone: Time from start nebulizing to serum peak prednisolone concentration (Tmax) and prednisolone area under. We derive this pharmacokinetic data from two…

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An Open-Label Extension Study of the Safety of Relacorilant (CORT125134) in the Treatment of the Signs and Symptoms of Endogenous Cushing Syndrome

Primary Objectives: Safety Assessments: Effect of Administration of Relacorilant on: • Incidence of TEAEs (assessed monthly): TEAEs, SAEs, treatment-related TEAEs, TEAEs leading to early discontinuation of study treatment• Clinical laboratory tests…

An Open-Label Extension Study of Levoketoconazole (2S,4R-ketoconazole) in the
Treatment of Endogenous Cushing*s Syndrome

The objective of this study is to assess long-term safety and efficacy durability of levoketoconazole as chronic treatment for endogenous Cushing*s Syndrome (CS).

Bioequivalence study of prednisolone and dexamethasone; corticosteriods revised

This study aims to re-examine the bioequivalence of prednisolone and dexamethasone at two different doses by assessing tissue specific glucocorticoids effects, including the immune system, brain functioning, hormonal axes, and renal parameters.

An Open Label Study to Assess the Safety and Efficacy of COR*003 (2S, 4R-Ketoconazole) in the Treatment of Endogenous Cushing's Syndrome

This study will be a single arm, open-label, dose titration study to assess efficacy, safety, tolerability and PK of COR-003 in subjects with CS with each subject serving as his/her own control.

Phase 2 Study of the Safety and Efficacy of CORT125134 in the Treatment of Endogenous Cushing*s Syndrome

The primary objective of the study is to assess the safety of CORT125134 in patients with endogenousCushing*s syndrome. The secondary objective of the study is to assess the evidence of reduction incortisol activity following treatment with…