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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
337
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 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.
Ximed Research SC - SOM230B2412
La Jolla, California, United States
Cedars Sinai Medical Center Cedars Sinai 4
Los Angeles, California, United States
Stanford Universtiy Medical Center Stanford Hospital & Clinics
Stanford, California, United States
University of Michigan Comprehensive Cancer Center SC-2
Ann Arbor, Michigan, United States
Memorial Sloan-Kettering Cancer Center SC
New York, New York, United States
Incidence of Adverse Events to Evaluate Long Term Safety Data
Collect long term safety data, i.e. SAEs and AEs. SAES will be reviewed and reported as part of the regular pharmacovigilance activities.
Time frame: Baseline up to approximately 10 years
Percentage of Patients With Clinical Benefit as Assessed by the Investigator
Efficacy was assessed by the investigator at each scheduled visit using a binary (yes/no) response confirming the investigator's judgement of clinical benefit (via the question: "Does investigator confirm that the subject continues to have clinical benefit from the study treatment"). No other measures of efficacy were used in this study.
Time frame: Baseline up to approximately 10 years
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Virginia Endocrinology Research SC
Chesapeake, Virginia, United States
Swedish Cancer Institute Swedish Cancer Institute (SC)
Seattle, Washington, United States
Recordati Investigative Site
CABA, Buenos Aires, Argentina
Recordati Investigative Site
Mar del Plata, Buenos Aires, Argentina
Recordati Investigative Site
Edegem, Antwerpen, Belgium
...and 84 more locations