Trial intelligence / Profile preview

Ketoconazole and octreotide combination therapy for treatment of Cushing's disease

2011-003264-77Phase 2

Key facts

Status
Active
Start
Sep 2011
Countries
1
Sponsor
Erasmus MC
Modality
Peptides, Small Molecules
Conditions
Corticotropin adenoma (ACTHoma)
01

Overview

Phase 2, single-arm trial of ketoconazole, octreotide and cabergoline in Corticotropin adenoma (ACTHoma), sponsored by Erasmus MC. Primary endpoint: Urinary free cortisol. Started Sep 2011; status: active.

02

Design

1 arm
Study design
Non-randomizedSingle group
  • Ketoconazole + octreotide then octreotide monotherapy

    Single-arm study in which all participants receive ketoconazole plus octreotide initially, followed by octreotide monotherapy for ongoing control of Cushing's disease.

03

Who it enrols

Adults with biochemically confirmed ACTH-dependent Cushing's syndrome originating from a pituitary adenoma (de novo, recurrent, or residual) are included; patients with impaired liver function are excluded.

04

Endpoints

Primary

  • Urinary free cortisol

Secondary

  • Cortisol diurnal rhythm (saliva and serum)

  • Bone metabolism parameters

  • Quality of life

  • Coagulation and fibrinolysis parameters

Beyond the preview

Go deeper on 2011-003264-77.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on 2011-003264-77.

Gosset Free

Get started with Gosset.

Enter your corporate email.

Work email preferred.

Book a call