DRUG
Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs
Status
Completed
Phase
Phase 1
Enrollment
36
Locations
4
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
The purpose of this study is to assess the safety and tolerability of pasireotide LAR in combination with everolimus in advanced metastatic gastroenteropancreatic or pulmonary neuroendocrine Tumors (NET).
Interventions
Treatment arms and agents.
DRUG
Everolimus followed by Pasireotide LAR + Everolimus
Timeline
From registration to results.
First posted
Dec 20, 2010
Study start
Nov 2010
Primary completion
Mar 2014
Study completion
Mar 2014
Results posted
Not reported
Registry updated
Dec 21, 2020
Outcomes
What the study measures.
Primary outcomes
Evaluate safety and tolerability profile of pasireotide LAR in combination with everolimus in patients with advanced metastatic NET
Time frame · 3 months
Secondary outcomes
Evaluate safety and tolerability of pasireotide LAR and/or everolimus in patients with advanced metastatic NET
Time frame · 15 months
To assess pharmacokinetic exposures of pasireotide LAR and everolimus during monotherapy and in combination therapy
Time frame · 15 months
To assess potential drug-drug interactions between pasireotide and everolimus during combination therapy
Time frame · 12 months
To assess symptom control (bowel movements and flushing episodes) with pasireotide LAR in combination with everolimus in patients with functioning tumors
Time frame · 15 months
To assess the biochemical response (chromograninA, CgA) to pasireotide LAR in combination with everolimus
Time frame · 15 months
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * Confirmed diagnosis of grade 1/2 advanced pulmonary or gastroenteropancreatic neuroendocrine tumor * Progressive disease within last 12 months (only patients with nonfunctional tumors) * Documented liver metastasis * Measurable disease per RECIST determined by multiphase MRI or triphasic CT Exclusion Criteria: * Previous treatment with radiolabeled somatostatin analogs within 12 months prior to reporting baseline symptoms * Previous treatment with mTOR inhibitors or pasireotide * Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study * Women who are pregnant or lactating Other protocol-defined inclusion/exclusion criteria may apply
Study locations
4 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
Marburg, 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
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