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Somatostatin Analog

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

Phase 4

Waitlist Available

Research Sponsored by RECORDATI GROUP

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to approximately 10 years

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial allows patients with Cushing's Disease and Acromegaly, who are already benefiting from pasireotide, to continue their treatment. Pasireotide helps manage their condition by controlling hormone production. The study ensures these patients can keep receiving the medication as long as they need it. Pasireotide is effective in treating Cushing's disease and acromegaly.

Eligible Conditions

Cushing's syndrome
Dumping Syndrome
Prostate Cancer
Neuroendocrine Tumors
Melanoma
Acromegaly
Hypercortisolism
Pituitary Tumors

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to approximately 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to approximately 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to approximately 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Adverse Events to Evaluate Long Term Safety Data

Secondary study objectives

Percentage of Patients With Clinical Benefit as Assessed by the Investigator

Side effects data

From 2023 Phase 4 trial • 337 Patients • NCT01794793

Nasopharyngitis

Back pain

Headache

Hypertension

Hyperglycaemia

Covid-19

Urinary tract infection

Influenza

Diabetes mellitus

Diarrhoea

Cholelithiasis

COVID-19

Appendicitis

Nephrolithiasis

Cholecystitis

Acute myocardial infarction

Cardiac failure

Myocardial infarction

Cellulitis

Coronary artery disease

COVID-19 pneumonia

Septic shock

Diabetic ketoacidosis

Hypoglycaemia

Epilepsy

Pulmonary embolism

100%

80%

60%

40%

20%

Study treatment Arm

All Subjects

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Pasireotide subcutaneousExperimental Treatment2 Interventions

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.

Group II: Pasireotide Long Acting Release (LAR)Experimental Treatment2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pasireotide

2004

Completed Phase 4

~1840

Pasireotide LAR

2013