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
- Conditions
- Cushing’s diseaseAcromegalyNeuroendocrine tumorsPituitary tumorsEctopic ACTH secreting (EAS) tumorsDumping SyndromeProstate cancerMelanoma negative for bRAF
- Registration Number
- EUCTR2013-000267-84-FR
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 100
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method