Cushing's disease Acromegaly Carcinoid tumors Rare tumors of neuroendocrine origin Dumping Syndrome Metastatic melanoma Metastatic Merkel cell carcinoma
Conditions
Interventions
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
Pharmaceutical Form: Solution for injection
INN or Proposed INN: pasireotide
CAS Number: 396091-73-9
Current Sponsor code: SOM230
Ot
Sponsors
Recordati AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient is currently participating in a Novartis Oncology sponsored study receiving pasireotide (LAR and/or s.c.) and has fulfilled all required assessments in the parent study (unless the study is being terminated) and patients that are benefiting from the study drug have no other alternatives. 2. Patient is currently benefiting from the treatment with pasireotide, as determined by the investigator 3. Patient has demonstrated compliance, as assessed by the investigator, with the parent study requirements. 4. Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures. 5. Written informed consent obtained prior to enrolling in roll-over study and receiving study medication. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: 1. Patient has been permanently discontinued from pasireotide study treatment in the parent study due to unacceptable toxicity, non-compliance to study procedures, withdrawal of consent or any other reason. 2. Pregnant or nursing (lactating) women 3. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the study treatment and for 30 days after the final dose of pasireotide s.c. and 84 days after the final dose of pasireotide LAR. 4. Sexually active males unless they use a condom during intercourse while taking drug and for 1 months after pasireotide s.c. last dose and 3 months after pasireotide LAR last dose and should not father a child in this period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate long term safety data;Secondary Objective: To evaluate clinical benefit as assessed by the investigator at scheduled visits;Primary end point(s): Frequency and severity of AEs/SAEs;Timepoint(s) of evaluation of this end point: 10 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Proportion of patients with clinical benefit as assessed by the investigator at scheduled visits;Timepoint(s) of evaluation of this end point: 10 years | — |
Countries
Australia, Belgium, Brazil, Bulgaria, Canada, China, France, Greece, Israel, Italy, Mexico, Poland, Portugal, Russian Federation, Spain, Thailand, United States
Contacts
Public ContactClinical Trial Information Desk
Recordati AG
Outcome results
None listed