Study to Allow Access to Pasireotide for Patients Benefiting From Pasireotide Treatment in Novartis-sponsored Studies

Summary

The purpose of this study is to allow continued use of pasireotide in patients who are on pasireotide treatment in a Novartis-sponsored study and are benefiting from the treatment as judged by the investigator.

Conditions

• Cushing's Disease
• Acromegaly
• Neuroendocrine Tumors
• Pituitary Tumors
• Ectopic ACTH Secreting (EAS) Tumors
• Dumping Syndrome
• Prostate Cancer
• Melanoma Negative for bRAF
• Melanoma Negative for nRAS

Interventions

DRUG

Pasireotide

Administered subcutaneously in strengths 0.3mg, 0.6mg and 0.9mg. Doses to be taken BID or TID, dependent on parent study guidelines.

DRUG

Cabergoline

Cabergoline tablet 0.5mg or 1.0mg taken by mouth once daily may be combined with subcutaneous formulation of pasireotide for Cushing's Disease or Acromegaly. Dose is dependent on parent study guidelines.

DRUG

Pasireotide LAR

Long Acting Release is administered by a single intramuscular (i.m.) monthly injection. The strengths are 10mg, 20mg, 40mg and 60mg. All doses to be taken q28days. Strength is dependent on parent study guidelines.

Sponsors & Collaborators

• RECORDATI GROUP

  lead INDUSTRY

Principal Investigators

• Recordati · Recordati AG

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-06-10

Primary Completion

2023-07-25

Completion

2023-07-25

FDA Drug

Yes

Countries

• United States
• Argentina
• Belgium
• Brazil
• Bulgaria
• Canada
• France
• Germany
• Greece
• Hungary
• India
• Israel
• Italy
• Japan
• Malaysia
• Mexico
• Netherlands
• Peru
• Poland
• Portugal
• Romania
• Russia
• South Korea
• Spain
• Switzerland
• Taiwan
• Thailand
• Turkey (Türkiye)

Study Locations