Main
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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:
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EUCTR |
Last refreshed on:
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7 January 2025 |
Main ID: |
EUCTR2013-000267-84-BE |
Date of registration:
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22/04/2013 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Study to roll over patients who have completed a study with pasireotide and benefit from the study treatment.
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Scientific title:
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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:
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05/06/2013 |
Target sample size:
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100 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-000267-84 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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Australia
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Belgium
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Brazil
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Bulgaria
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Canada
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China
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France
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Greece
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Israel
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Italy
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Mexico
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Poland
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Portugal
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Russian Federation
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Spain
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Thailand
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United States
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Contacts
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Name:
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Clinical Trial Information Desk
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Address:
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Lindenstrasse, 8
6340
Baar
Switzerland |
Telephone:
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Email:
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clinicaltrials.endocrinology@recordati.com |
Affiliation:
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Recordati AG |
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Name:
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Clinical Trial Information Desk
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Address:
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Lindenstrasse, 8
6340
Baar
Switzerland |
Telephone:
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Email:
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clinicaltrials.endocrinology@recordati.com |
Affiliation:
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Recordati AG |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Cushing's disease
Acromegaly
Carcinoid tumors
Rare tumors of neuroendocrine origin
Dumping Syndrome
Metastatic melanoma
Metastatic Merkel cell carcinoma
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Therapeutic area: Diseases [C] - Hormonal diseases [C19]
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Intervention(s)
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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
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Primary Outcome(s)
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Primary end point(s): Frequency and severity of AEs/SAEs
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Secondary Objective: To evaluate clinical benefit as assessed by the investigator at scheduled visits
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Main Objective: To evaluate long term safety data
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Timepoint(s) of evaluation of this end point: 10 years
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: 10 years
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Secondary end point(s): Proportion of patients with clinical benefit as assessed by the investigator at scheduled visits
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Secondary ID(s)
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CSOM230B2412
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2013-000267-84-IT
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Source(s) of Monetary Support
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Recordati AG
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Ethics review
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Status: Approved
Approval date: 05/06/2013
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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