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

NCT01253161 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: MCC-16438CSOM230DUS23T
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Neuroendocrine Tumors; Carcinoid Tumors

Keywords

advanced; metastatic; unresectable; carcinoma; gastrointestinal tract; lungs; colon; liver; rectum; small intestine; stomach; pancreatic

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS) at One Year

  PFS: Defined as the time from the date of first study treatment to the date of the first documented disease progression, by Response Evaluation Criteria in Solid Tumors (RECIST 1.0) guidelines, or death due to any cause. Progressive Disease (PD): at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.

  12 months

Secondary Outcomes (2)

• Overall Radiographic Response Rate (ORR)

  Up to 48 months

• Adverse Events Possibly Related to Study Treatment

  Up to 48 months

Study Arms (1)

Pasireotide LAR Treatment

EXPERIMENTAL

The investigational drug used in this study is pasireotide long acting release (LAR) 60 mg.

Drug: Pasireotide Long Acting Release (LAR)

Interventions

Pasireotide Long Acting Release (LAR) DRUG

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.

Also known as: SOM 230

Pasireotide LAR Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• No prior systemic antineoplastic neuroendocrine tumor treatment (including prior somatostatin analogs). However patients who have received a short course of subcutaneous (SQ) octreotide (\<10 days) in the past are eligible if \> 1 week has elapsed from their last octreotide injection.
• 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.
• Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 14 days of the administration of the first study treatment. Women must not be lactating. Both men and WOCBP must be advised of the importance of using effective birth control measures during the course of the study.
• Signed informed consent to participate in the study must be obtained from patients after they have been fully informed of the nature and potential risks by the investigator (or his/her designee) with the aid of written information.

You may not qualify if:

• 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
• Corrected QT interval (QTcF) of \>470 msec on screening Electrocardiogram (ECG)
• Risk factors for Torsades de Pointes such as cardiac failure, clinically significant/symptomatic bradycardia
• Clinically significant hypokalemia or hypomagnesemia that are not correctable
• History of sustained ventricular tachycardia, ventricular fibrillation, advanced heart block, or idiopathic syncope thought to be related to ventricular arrhythmia
• Concomitant medication(s) known to increase the QT interval

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Novartis Pharmaceuticals: collaborator
• RECORDATI GROUP: collaborator

Study Sites (2)

Stanford Cancer Institute

Stanford, California, 94305, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Related Publications (1)

• Cives M, Kunz PL, Morse B, Coppola D, Schell MJ, Campos T, Nguyen PT, Nandoskar P, Khandelwal V, Strosberg JR. Phase II clinical trial of pasireotide long-acting repeatable in patients with metastatic neuroendocrine tumors. Endocr Relat Cancer. 2015 Feb;22(1):1-9. doi: 10.1530/ERC-14-0360. Epub 2014 Nov 6.

  PMID: 25376618 DERIVED

MeSH Terms

Conditions

Neuroendocrine Tumors; Carcinoid Tumor; Neoplasm Metastasis; Carcinoma

Interventions

pasireotide

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Jonathan Strosberg, MD
• Organization: Moffitt Cancer Center

Jonathan.Strosberg@moffitt.org

813-745-6585

Study Officials

• Jonathan Strosberg, M.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2010
• First Posted: December 3, 2010
• Study Start: February 1, 2011
• Primary Completion: October 6, 2021
• Study Completion: March 2, 2023
• Last Updated: March 6, 2023
• Results First Posted: January 18, 2022

Record last verified: 2023-03

Locations

US (2)