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

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Brief Title

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

Official Title

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

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.
    

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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Rate of Progression-free Survival (PFS) at One Year

Secondary Outcome

 Median Overall Survival (OS)

Condition

Neuroendocrine Tumors

Intervention

Pasireotide Long Acting Release (LAR)

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

29

Start Date

February 1, 2011

Completion Date

December 2022

Primary Completion Date

December 2020

Eligibility Criteria

        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.

          -  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.

        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

          -  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

          -  History of noncompliance to medical regimens or unwillingness to comply with the
             protocol
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jonathan Strosberg, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01253161

Organization ID

MCC-16438

Secondary IDs

CSOM230DUS23T

Responsible Party

Sponsor

Study Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

 Novartis Pharmaceuticals

Study Sponsor

Jonathan Strosberg, M.D., Principal Investigator, H. Lee Moffitt Cancer Center and Research Institute


Verification Date

July 2020