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

Phase 1

• Conditions: Cushing's diseaseAcromegalyNeuroendocrine tumorsPituitary tumorsEctopic ACTH secreting (EAS) tumorsDumping SyndromeProstate cancerMelanoma negative for bRAF; MedDRA version: 21.0Level: LLTClassification code 10062476Term: Neuroendocrine tumorSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10011651Term: Cushing's diseaseSystem Organ Class: 100000004860; MedDRA version: 20.0Level: LLTClassification code 10000600Term: Acromegaly and gigantismSystem Organ Class: 100000004860; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2013-000267-84-PL
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-16
• Last Update Posted: 12 December 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

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 78
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 11

Exclusion Criteria

1. Patient has been permanently discontinued from pasireotide study
treatment in the parent study due to unacceptable toxicity, noncompliance
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified