DRUG
Evaluate Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs
Status
Completed
Phase
Phase 1
Enrollment
18
Locations
3
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
This study will evaluate long-term safety and tolerability of pasireotide LAR in combination with everolimus in advanced metastatic NET patients, who who have not progressed during 12 months of combination therapy with pasireotide LAR and everolimus
Interventions
Treatment arms and agents.
DRUG
SOM230
Timeline
From registration to results.
First posted
May 2, 2012
Study start
May 18, 2012
Primary completion
Sep 11, 2018
Study completion
Sep 11, 2018
Results posted
Not reported
Registry updated
Apr 16, 2019
Outcomes
What the study measures.
Primary outcomes
Number of Participants with Adverse Events and Serious Adverse Enents as a Measure of Safety and Tolerability
Time frame · up to 4 years
Number of Participants with abnormal laboratory and ECG results as a Measure of Safety and Tolerability
Time frame · up to 4 years
Secondary outcomes
investigator-assessed progression free survival (PFS)
Time frame · up to 4 years
best overall response
Time frame · up to 4 years
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion and Exclusion Criteria: Patients eligible for inclusion in this extension study have to meet all of the additional inclusion criteria: * The patient must provide a signed Informed Consent Form (ICF) for the extension study prior to any study related procedures * Completion of the whole treatment period of 15 months (3 months monotherapy with either pasireotide LAR or everolimus followed by a 12 months combination of pasireotide LAR/everolimus) in the CSOM230F2102 study * No tumor progression during 12 months of combination therapy with pasireotide LAR and everolimus (checked via radiologically assessment). No intolerable toxicity during combination therapy with pasireotide LAR and everolimus
Study locations
3 registered sites.
Germany. Showing up to 24 locations stored in the fast local snapshot.
Novartis Investigative Site
Bad Berka, Germany
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Münster, Germany
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Pasireotide.
NCT IDStudyPhase / statusEnrollmentUpdated
Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Grade 2 Advanced GEP-NET
Novartis · Somatostatin Receptor Positive (SSTR+) · Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET)
Phase 3
Recruiting
240
2026-04
A Study of Pasireotide in People With Prolactinoma
Memorial Sloan Kettering Cancer Center · Prolactin-Producing Pituitary Tumor
Phase 2
Recruiting
10
2026-03
Study in Healthy Subjects to Investigate the Relative Bioavailability and Safety of Pasireotide After Single Subcutaneous Dose Administration Using a Reusable ServoPen With Cartridge as Compared to Administration Using a Syringe Drawn From an Ampule
RECORDATI GROUP · Pharmacokinetics · Safety
Phase 1
Completed
40
2026-02
Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET
Advanced Accelerator Applications · Gastro-enteropancreatic Neuroendocrine Tumor
Phase 3
Active, not recruiting
226
2026-01
Reduction by Pasireotide of the Effluent Volume in High-output Enterostomy in Patients Refractory to Usual Medical Treatment
Hospices Civils de Lyon · Enterostomy
Phase 2
Completed
57
2025-12
Pasireotide s.c. in Patients With Post-Bariatric Hypoglycaemia
RECORDATI GROUP · Post-Bariatric Hypoglycemia
Phase 2
Active, not recruiting
93
2025-09
Effects of Pasireotide Lar Therapy on Bone Metabolism
Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Acromegaly Due to Pituitary Adenoma · Acromegaly
Not applicable
Recruiting
120
2025-09
Pasireotide (SOM230) With or Without Everolimus in Treating Patients With Hormone Resistant, Chemotherapy Naive Prostate Cancer
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Castrate Resistant Prostate Cancer · Chemotherapy Naive Prostate Cancer
Phase 2
Terminated
6
2025-04
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.