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COMPLETEDPHASE2

Study of Pasireotide Long Acting Release (LAR) in Patients With Metastatic Neuroendocrine Tumors (NETs)

Phase II Study of Pasireotide LAR in Patients With Metastatic Neuroendocrine Carcinomas

NCT01253161•H. Lee Moffitt Cancer Center and Research Institute

Summary

The goal of this clinical research study is to learn if the study drug, Pasireotide LAR can shrink or slow the growth of Metastatic Neuroendocrine Carcinomas. The safety of this drug will also be studied. The patient's physical state, changes in the size of the tumor, and laboratory findings taken while on-study will help us decide if Pasireotide LAR is safe and effective.

Detailed Description

This is a multi-institutional, prospective phase II open-label trial. The investigational drug used in this study is pasireotide LAR 60 mg. Pasireotide will be administered as an intramuscular injection at the beginning of every cycle which is defined as 28 days (+/- 3 days). Study treatment should begin within 14 days following enrollment into the study and continue until disease progression, unacceptable toxicity, or withdrawal of consent. Safety and efficacy will be assessed throughout the treatment period.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Locally unresectable or metastatic carcinoid or pancreatic neuroendocrine tumors
•Tumors must be considered well or moderately differentiated (or low to intermediate grade). Patients with poorly differentiated neuroendocrine carcinomas or small cell carcinomas are excluded from the study.
•Minimum of four weeks since any major surgery
•Measureable disease by Response Evaluation Criteria in Solid Tumors (RECIST)
•Eastern Cooperative Oncology Group (ECOG) performance status ≤1
•Life expectancy 12 weeks or more
•Adequate bone marrow function as shown by: absolute neutrophil count (ANC) ≥ 1.0 x 10\^9/L, Platelets ≥ 75 x 10\^9/L, hemoglobin (Hgb) \> 8 g/dL
•Adequate liver function as shown by: serum bilirubin ≤ 2.0 x upper limit of normal (ULN), and serum transaminases activity ≤ 2 x ULN, with the exception of serum transaminases (\< 3 x ULN) if the patient has liver metastases
•Adequate renal function as shown by serum creatinine ≤ 2.0 x ULN
•Fasting serum cholesterol ≤300 mg/dL OR ≤7.75 mmol/L AND fasting triglycerides ≤ 2.5 x ULN. Note: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication.
+2 more criteria

Exclusion Criteria

•Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases
•Patients with prior or concurrent malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, or other adequately treated in situ cancer, or any other cancer from which the patient has been disease free for 5 years
•Patients with uncontrolled diabetes mellitus or a fasting plasma glucose \> 1.5 ULN or glycosylated hemoglobin (HbA1c) \>8%. Note: At the principle investigator's discretion, non-eligible patients can be re-screened after adequate medical therapy has been instituted.
•Patients with symptomatic cholelithiasis
•Patients who have congestive heart failure: New York Heart Association (NYHA) Class III or IV, unstable angina, or a history of acute myocardial infarction within the 6 months preceding enrollment
•Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
•* Severely impaired lung function
•* Any active (acute or chronic) or uncontrolled infection/ disorders
•* Nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy
•Known hypersensitivity to somatostatin analogues or any component of the pasireotide LAR formulation
+6 more criteria

Locations (2)

Stanford Cancer Institute

Stanford, California, United States

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Key Dates

Start Date

February 1, 2011

Primary Completion Date

October 6, 2021

Completion Date

March 2, 2023

Last Updated

March 6, 2023

Enrollment

ACTUAL participants

Conditions

Neuroendocrine TumorsCarcinoid Tumors

Interventions

Pasireotide Long Acting Release (LAR)

DRUG

Lenvatinib Plus Pembrolizumab in Well Differentiated G3 Neuroendocrine Tumors

NCT05746208

Neuroendocrine TumorsWell-Differentiated Neuroendocrine Carcinoma+1 more

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RECRUITINGPHASE2

Lurbinectedin With or Without Avelumab in Small Cell Carcinoma of the Bladder (LASER)

NCT06228066

Small Cell Carcinoma of the BladderHigh Grade Neuroendocrine Tumors of the Urinary Tract

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 6, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study of Pasireotide Long Acting Release (LAR) in Patients With Metastatic Neuroendocrine Tumors (NETs)

Inclusion Criteria

Exclusion Criteria

Lenvatinib Plus Pembrolizumab in Well Differentiated G3 Neuroendocrine Tumors

Lurbinectedin With or Without Avelumab in Small Cell Carcinoma of the Bladder (LASER)

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