Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

Collaborator: Novartis Pharmaceuticals

Stanford Investigator(s):

Intervention(s):

  • Drug: Pasireotide Long Acting Release (LAR)

Phase:

Phase 2

Eligibility


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 Tosades 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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting