Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Nervous System Diseases

Gland and Hormone Related Diseases

Musculoskeletal Diseases

Heart and Blood Diseases

Digestive System Diseases

Rare Diseases

Syndrome

Melanoma

Prostatic Neoplasms

Pituitary Diseases

Neuroendocrine Tumors

Acromegaly

Cardiac Complexes, Premature

Pituitary Neoplasms

ACTH-Secreting Pituitary Adenoma

Pituitary ACTH Hypersecretion

Dumping Syndrome

Adenoma

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Hypothalamic Diseases

Brain Diseases

Central Nervous System Diseases

Endocrine System Diseases

Bone Diseases

Bone Diseases, Endocrine

Endocrine Gland Neoplasms

Hypothalamic Neoplasms

Supratentorial Neoplasms

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Neoplasms, Glandular and Epithelial

Postgastrectomy Syndromes

Stomach Diseases

Gastrointestinal Diseases

Postoperative Complications

Neuroendocrine Tumor

ACTH-secreting Pituitary Adenoma

Neuroepithelioma

Anti-Dyskinesia Agents

All Drugs and Chemicals

Gastrointestinal Agents

Cardiotonic Agents

Cabergoline

Pasireotide

Lactitol

Somatostatin

Hormones

Hormone Antagonists

Antiparkinson Agents

Dopamine

Dopamine Agonists

Dopamine Agents

Neurotransmitter Agents

0.3mg, 0.6mg and 0.9mg. Doses to be taken BID or TID, dependent on parent study guidelines. Cabergoline may be combined in this arm for Cushing's Disease and Acromegaly patients.

10mg, 20mg, 40mg and 60mg. All doses to be taken q28days. Strength is dependent on parent study guidelines.

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

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.

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

Recordati

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.

This is a multi-center, open label, phase IV study to provide continued supply of pasireotide to patients being treated in a current Novartis-sponsored study and who are benefiting from treatment with pasireotide alone or in combination with another treatment for Cushing's Disease and Acromegaly . Eligible patients are to be consented and can then continue treatment with pasireotide alone or in combination with another treatment for Cushing's Disease and Acromegaly in this protocol. All patients at their scheduled visits will have drug dispensing information and reported adverse events and serious adverse events collected.

A patient will reach the end of study when pasireotide treatment is permanently discontinued and the end of treatment visit has been performed. All patients must be followed up for safety evaluations for 3 months following the last dose of pasireotide LAR treatment and for 1 month following the last dose of pasireotide s.c. treatment.

The study is expected to remain open for approximately 10 years or until such time that enrolled patients no longer need treatment with pasireotide or are able to obtain commercial supply according to local regulations for their medical condition.

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

An Open Label, Multi-center Pasireotide Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Pasireotide Study and Are Judged by the Investigator to Benefit From Continued Pasireotide Treatment

Collect long term safety data, i.e. SAEs and AEs. SAES will be reviewed and reported as part of the regular pharmacovigilance activities.

Clinical benefit rate as defined by Investigator based on the patients 24 hour Urinary Free Cortisol results.

RECORDATI GROUP

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study to Allow Access to Pasireotide for Patients Benefiting From Pasireotide Treatment in Novartis-sponsored Studies	NCT01794793	Cushing's Disea... Acromegaly Neuroendocrine ... Pituitary Tumor... Ectopic ACTH Se... Dumping Syndrom... Prostate Cancer Melanoma Negati... Melanoma Negati...	Pasireotide Cabergoline Pasireotide	18 Years -	RECORDATI GROUP
Study to Allow Access to Pasireotide for Patients Benefiting From Pasireotide Treatment in Novartis-sponsored Studies	NCT01794793	Cushing's Disea... Acromegaly Neuroendocrine ... Pituitary Tumor... Ectopic ACTH Se... Dumping Syndrom... Prostate Cancer Melanoma Negati... Melanoma Negati...	Pasireotide Cabergoline Pasireotide	18 Years -	RECORDATI GROUP

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