DRUG
Dose Escalation Study of Pasireotide (SOM230) in Patients With Advanced Neuroendocrine Tumors (NETs)
Status
Completed
Phase
Phase 1
Enrollment
29
Locations
4
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
This study designed to determine the Maximum Tolerated Dose (MTD) for patients with advanced Neuroendocrine Tumors (NETs) and to characterize the safety, tolerability, Pharmacokinetics and preliminary efficacy of pasireotide LAR administered i.m. once every 28 days.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Jun 2, 2011
Study start
Aug 2011
Primary completion
Apr 2016
Study completion
Apr 2016
Results posted
Not reported
Registry updated
Dec 21, 2020
Outcomes
What the study measures.
Primary outcomes
Determine the MTD/RP2D of pasireotide LAR when administered i.m. q28 days to patients with advanced NETs
Time frame · Sequentiona 56 day cohorts until the MTD is determined
Frequency of dose-limiting toxicities (DLTs) at each dose level associated with q28 days administration of pasireotide LAR during the first 2 treatment cycles.
Secondary outcomes
assess the safety and tolerability of pasireotide LAR
Time frame · minimum of twelve 28 day cycles to approximately eighteen 28 day cycles
Incidence of adverse drug events, overall and by severity and incidence of serious adverse events and laboratory abnormalities. Also, changes in laboratory assessments, electrocardiograms, Holter monitor, imaging for gallstones, and assessment of physical examinations such as vital signs
assess the pharmacokinetics (PK) of pasireotide LAR
Time frame · minimum of twelve 28 day cycles to approximately eighteen 28 day cycles
Pasireotide Cmax and Ctrough
assess the pharmacodynamics (PD) of pasireotide LAR
Time frame · minimum of twelve 28 day cycles to approximately eighteen 28 day cycles
Changes from baseline values in IGF-1, chromogranin A and neuron-specific enolase
assess the preliminary efficacy (anti-tumor activity) of pasireotide LAR.
Time frame · minimum of twelve 28 day cycles to approximately eighteen 28 day cycles
Disease control rate (CR+PR+SD as assessed by RECIST 1.0). Also measure progression free survival (PFS).
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * ≥18 yrs old, histologically confirmed advanced well or moderately differentiated neuroendocrine tumor/carcinoma * unresectable metastatic NET tumor with measurable disease * life expectancy ≥ 12 weeks Exclusion Criteria: * Patients with CNS metastases who are neurologically unstable or requiring increasing doses of steroids to control their CNS disease * patients with known hypersensitivity to somatostatin analogs * patients with symptomatic cholelithiasis in the past 2 months * patients with history of another known primary malignancy with exception of non-melanoma skin cancer or carcinoma in situ of uterine cervix * patients with known history of hepatitis C or chronic active hepatitis B * patients with diagnosis of HIV. Other protocol-defined inclusion/exclusion criteria may apply
Study locations
4 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Cedars Sinai Medical Center Cedars Sinai 4
Los Angeles, California, United States
H. Lee Moffitt Cancer Center & Research Institute SC-1
Tampa, Florida, United States
Dana Farber Cancer Institute SC-6
Boston, Massachusetts, United States
University of Texas/MD Anderson Cancer Center UT MD Anderson Cancer Ctr
Houston, Texas, United States
Publications
Results and literature.
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.