Study to roll over patients who have completed a study with pasireotide and benefit from the study treatment.

• 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
• Affiliation: Recordati AG

• Name: Clinical Trial Information Desk
• 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)

Timepoint(s) of evaluation of this end point: 10 years

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

Secondary Outcome(s)

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

Secondary ID(s)

CSOM230B2412

2013-000267-84-IT

Source(s) of Monetary Support

Recordati AG

Ethics review

Status: Approved
Approval date: 05/06/2013
Contact: