Efficacy and Safety of Pasireotide Administered Monthly in Patients With Cushing's Disease

Novartis

Status and phase: Completed; Phase 3

Conditions: Cushing's Disease

Treatments: Drug: SOM230 LAR 30 mg; Drug: pasireotide LAR; Drug: SOM230 LAR 10 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01374906

2009-011128-70 (EudraCT Number)

CSOM230G2304

Details and patient eligibility

About

This is a randomized, double-blind, multicenter, phase III study to evaluate the safety and efficacy of 2 dosing regiments of Pasireotide long acting release (LAR) in patients with Cushing's disease.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Karnofsky performance status ≥ 60 (i.e. requires occasional assistance, but is able to care for most of their personal needs)

• For patients on medical treatment for Cushing's disease the following washout periods must be completed before screening assessments are performed

  • Inhibitors of steroidogenesis (ketoconazole, metyrapone): 1 week
  • Pituitary directed agents: Dopamine agonists (bromocriptine, cabergoline) and PPARγ agonists (rosiglitazone or pioglitazone): 4 weeks
  • Octreotide LAR, Lanreotide SR and Lanreotide autogel: 14 weeks
  • Octreotide (immediate release formulation): 1 week

Exclusion criteria

• Patients who are considered candidates for surgical treatment at the time of study entry
• Patients who have received pituitary irradiation within the last ten years prior to visit 1
• Patients who have had any previous pasireotide treatment
• Patients who have been treated with mitotane during the last 6 months prior to Visit 1
• Diabetic patients on antihyperglycemic medications with poor glycemic control as evidenced by HbA1c >8%
• Patients with risk factors for torsade de pointes, i.e. patients with a baseline QTcF >470 ms, hypokalemia, uncontrolled hypothyroidism, family history of long QT syndrome, or concomitant medications known to prolong QT interval
• Female patients who are pregnant or lactating, or are of childbearing potential (defined as all women physiologically capable of becoming pregnant) and not practicing an effective method of contraception/birth control. Sexually active males must use a condom during intercourse while taking the drug and for 2 months after the last dose of study drug and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 2 patient groups

10 mg LAR dose

Experimental group

Description:

Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms.

Treatment:

Drug: SOM230 LAR 10 mg

Drug: pasireotide LAR

30 mg LAR dose

Experimental group

Description:

Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms.

Treatment:

Drug: SOM230 LAR 30 mg

Drug: pasireotide LAR