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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 7 January 2025
Main ID:  EUCTR2013-000267-84-BE
Date of registration: 22/04/2013
Prospective Registration: Yes
Primary sponsor: Recordati AG
Public title: Study to roll over patients who have completed a study with pasireotide and benefit from the study treatment.
Scientific title: An open label, multicenter 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
Date of first enrolment: 05/06/2013
Target sample size: 100
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-000267-84
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes
Countries of recruitment
Australia Belgium Brazil Bulgaria Canada China France Greece
Israel Italy Mexico Poland Portugal Russian Federation Spain Thailand
United States
Contacts
Name: Clinical Trial Information Desk   
Address:  Lindenstrasse, 8 6340 Baar Switzerland
Telephone:
Email: clinicaltrials.endocrinology@recordati.com
Affiliation:  Recordati AG
Name: Clinical Trial Information Desk   
Address:  Lindenstrasse, 8 6340 Baar Switzerland
Telephone:
Email: clinicaltrials.endocrinology@recordati.com
Affiliation:  Recordati AG
Key inclusion & exclusion 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:
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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Cushing's disease Acromegaly Carcinoid tumors Rare tumors of neuroendocrine origin Dumping Syndrome Metastatic melanoma Metastatic Merkel cell carcinoma
Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Intervention(s)

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
Other descriptive name: PASIREOTIDE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 0.9-

Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: pasireotide
CAS Number: 396091-73-9
Current Sponsor code: SOM230
Other descriptive name: PASIREOTIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-

Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: pasireotide
CAS Number: 396091-73-9
Current Sponsor code: SOM230
Other descriptive name: PASIREOTIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-

Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: pasireotide
CAS Number: 396091-73-9
Current Sponsor code: SOM230
Other descriptive name: PASIREOTIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 60-

Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: pasireotide
CAS Number: 396091-73-9
Current Sponsor code: SOM230
Other descriptive name: PASIREOTIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-

Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
P
Primary Outcome(s)
Primary end point(s): Frequency and severity of AEs/SAEs
Secondary Objective: To evaluate clinical benefit as assessed by the investigator at scheduled visits
Main Objective: To evaluate long term safety data
Timepoint(s) of evaluation of this end point: 10 years
Secondary Outcome(s)
Timepoint(s) of evaluation of this end point: 10 years
Secondary end point(s): Proportion of patients with clinical benefit as assessed by the investigator at scheduled visits
Secondary ID(s)
CSOM230B2412
2013-000267-84-IT
Source(s) of Monetary Support
Recordati AG
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 05/06/2013
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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