Cushing's disease Acromegaly Carcinoid tumors Rare tumors of neuroendocrine origin Dumping Syndrome Metastatic melanoma Metastatic Merkel cell carcinoma MedDRA version: 20.0 Level: PT Classification code 10000599 Term: Acromegaly System Organ Class: 10014698 - Endocrine disorders MedDRA version: 21.0 Level: LLT Classification code 10007271 Term: Carcinoid tumor System Organ Class: 100000004864 MedDRA version: 21.0 Level: LLT Classification code 10062476 Term: Neuroendocrine tumor Syst
Conditions
Interventions
Trade Name: Signifor
Product Name: pasireotide 20mg
Product Code: SOM230
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: pasireotide
CAS Number: 396091-73-9
C
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 220 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1
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. Patient has participated in a Novartis sponsored combination trial where pasireotide was dispensed in combination with another study medication and is still receiving combination therapy 3. Pregnant or nursing (lactating) women 4. 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. 5. 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: Throughout the trial | — |
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: at scheduled visits | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, France, Greece, Israel, Italy, Korea, Republic of, Mexico, Netherlands, Poland, Portugal, Russian Federation, Spain, Taiwan, Thailand, United States
Contacts
Public ContactClinical Trial Information Desk
Recordati AG
Outcome results
None listed