Safety and Efficacy of Different Dose Levels of Pasireotide in Patients With de Novo, Persistent or Recurrent Cushing's Disease

Novartis

Status and phase: Completed; Phase 3

Conditions: Cushing's Disease

Treatments: Drug: Pasireotide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00434148

CSOM230B2305

2006-004111-22 (EudraCT Number)

Details and patient eligibility

About

This study will evaluate the safety and efficacy of two different doses of Pasireotide in patients with de novo or recurrent/persistent Cushing's Disease.

Enrollment: 162 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• 18 years or greater
• Confirmed diagnosis of ACTH-dependent Cushing's disease
• Not considered candidate for pituitary surgery

Exclusion criteria

• History of pituitary irradiation in the last 10 years
• Cushing's syndrome not caused by pituitary tumor
• Patients with active malignant disease (cancer) in the last 5 years
• Women who are pregnant or lactating

Other protocol-defined inclusion/exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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162 participants in 2 patient groups

Pasireotide 600 ug

Experimental group

Description:

At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was \<= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.

Treatment:

Drug: Pasireotide

Pasireotide 900 ug

Experimental group

Description:

At randomization, participants received 900 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was \<= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.

Treatment:

Drug: Pasireotide