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Somatostatin Analog

Pasireotide Long Acting Release (LAR) for Neuroendocrine Tumors

Phase 2
Waitlist Available
Led By Jonathan Strosberg, M.D.
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 months
Awards & highlights

Study Summary

This trial will study the effects of Pasireotide LAR on patients with Metastatic Neuroendocrine Carcinomas. The safety and efficacy of the drug will be measured by changes in the size of the tumor and the patient's physical state.

Eligible Conditions
  • Neuroendocrine Tumors
  • Carcinoid Tumor

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free Survival (PFS) at One Year
Secondary outcome measures
Adverse Events Possibly Related to Study Treatment
Overall Radiographic Response Rate (ORR)

Side effects data

From 2023 Phase 2 trial • 29 Patients • NCT01253161
83%
Hyperglycemia
41%
Fatigue
38%
Diarrhea
31%
Abdominal pain
28%
Hypertension
21%
Constipation
17%
Nausea
17%
Vomiting
17%
Headache
17%
Dyspnea
14%
Edema limbs
14%
Back pain
14%
Dizziness
14%
Anorexia
14%
Gastrointestinal disorders - Other
10%
Myalgia
10%
Pain
10%
Alkaline phosphatase increased
10%
Rash maculo-papular
7%
Skin and subcutaneous tissue disorders - Other
7%
Blurred vision
7%
Bone pain
7%
Pain in extremity
7%
Chills
7%
Fever
7%
Alanine aminotransferase increased
7%
Aspartate aminotransferase increased
7%
Creatinine increased
7%
Cough
7%
Respiratory, thoracic and mediastinal disorders - Other
7%
Weight loss
7%
Hyperkalemia
7%
Hyponatremia
7%
Depression
7%
Anemia
7%
Cardiac disorders - Other
7%
Bloating
3%
Bladder infection
3%
Breast pain
3%
Renal and urinary disorders - Other
3%
Pruritus
3%
Arthralgia
3%
Musculoskeletal and connective tissue disorder - Other
3%
Ileal obstruction
3%
Dyspepsia
3%
Malabsorption
3%
Mucositis oral
3%
Small intestinal obstruction
3%
Non-cardiac chest pain
3%
Neck pain
3%
Platelet count decreased
3%
Flushing
3%
Hot flashes
3%
Dysgeusia
3%
Nervous system disorders - Other
3%
Hoarseness
3%
Productive cough
3%
Sneezing
3%
Flatulence
3%
Gastritis
3%
Blood bilirubin increased
3%
Investigations - Other
3%
Pancreatic enzymes decreased
3%
Weight gain
3%
Peripheral sensory neuropathy
3%
Wheezing
3%
Dehydration
3%
Glucose intolerance
3%
Hypercalcemia
3%
Hypermagnesemia
3%
Hypokalemia
3%
Eye disorders - Other
3%
Anxiety
3%
Insomnia
3%
Urinary frequency
3%
Vaginal discharge
3%
Cholecystitis
3%
Bruising
3%
Kidney infection
3%
Skin infection
3%
Cardiac Disorders - Other
3%
Dueodenal obstruction
3%
Lung infection
3%
Sinus tachycardia
3%
Colonic perforation
3%
Bronchial infection
3%
Infections and infestations - Other
3%
Urinary tract infection
3%
Dry skin
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pasireotide LAR Treatment

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pasireotide LAR TreatmentExperimental Treatment1 Intervention
The investigational drug used in this study is pasireotide long acting release (LAR) 60 mg.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pasireotide Long Acting Release (LAR)
2011
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
543 Previous Clinical Trials
135,466 Total Patients Enrolled
8 Trials studying Neuroendocrine Tumors
284 Patients Enrolled for Neuroendocrine Tumors
Novartis PharmaceuticalsIndustry Sponsor
2,858 Previous Clinical Trials
4,197,827 Total Patients Enrolled
29 Trials studying Neuroendocrine Tumors
2,731 Patients Enrolled for Neuroendocrine Tumors
RECORDATI GROUPIndustry Sponsor
12 Previous Clinical Trials
4,481 Total Patients Enrolled
1 Trials studying Neuroendocrine Tumors
413 Patients Enrolled for Neuroendocrine Tumors

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Endocrine-Related CancerJournal
Phase II Clinical Trial of Pasireotide Long-acting Repeatable in Patients with Metastatic Neuroendocrine Tumors
Cives, M, P L Kunz, B Morse, D Coppola, M J Schell, T Campos, P T Nguyen, P Nandoskar, V Khandelwal, and J R Strosberg. 2014. “Phase II Clinical Trial of Pasireotide Long-acting Repeatable in Patients with Metastatic Neuroendocrine Tumors”. Endocrine-related Cancer. Bioscientifica. doi:10.1530/erc-14-0360.
clinicaltrials.govStudy
Study of Pasireotide Long Acting Release (LAR) in Patients With Metastatic Neuroendocrine Tumors (NETs)
2011. "Study of Pasireotide Long Acting Release (LAR) in Patients With Metastatic Neuroendocrine Tumors (NETs)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01253161.
~2 spots leftby Apr 2025
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