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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT01253161
First received: November 30, 2010
Last updated: May 6, 2016
Last verified: May 2016

November 30, 2010
May 6, 2016
January 2011
December 2016   (final data collection date for primary outcome measure)
Rate of Progression-free Survival (PFS) at One Year [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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.
Progression-free survival (PFS) [ Time Frame: Average of 12 months ] [ Designated as safety issue: No ]
Rate of PFS
Complete list of historical versions of study NCT01253161 on ClinicalTrials.gov Archive Site
  • Median Overall Survival (OS) [ Time Frame: Up to 48 months ] [ Designated as safety issue: No ]
    OS: The date of first study treatment to the date of death due to any cause.
  • Overall Radiographic Response Rate (ORR) [ Time Frame: Up to 48 months ] [ Designated as safety issue: No ]
    Complete response (CR): complete disappearance of all target lesions, confirmed by repeat assessments at no less than 4 weeks after the criteria for response are first met. Partial response (PR): at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. This must be confirmed by repeat assessment at no less than 4 weeks after the criteria for response are first met. Stable Disease (SD): neither sufficient decrease to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started.
  • Occurrence of Adverse Events Possibly Related to Study Treatment [ Time Frame: Up to 48 months ] [ Designated as safety issue: Yes ]
    Adverse Events (AEs) and Serious Adverse Events (SAEs) will be evaluated continuously throughout the study. Safety and tolerability will be assessed according to the NIH/NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0).
  • Overall survival (OS) [ Time Frame: Average of 24 months ] [ Designated as safety issue: No ]
  • Overall radiographic response rate (ORR) [ Time Frame: Average of 12 months ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability [ Time Frame: Average of 12 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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
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.

This is a multi-institutional, prospective phase II open-label trial.

The investigational drug used in this study is pasireotide LAR 60mg. 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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Neuroendocrine Tumors
  • Carcinoid Tumors
Drug: Pasireotide Long Acting Release (LAR)
Intramuscular injection of Pasireotide LAR
Other Name: SOM 230
Experimental: Treatment phase
Intervention: Drug: Pasireotide Long Acting Release (LAR)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
29
December 2016
December 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01253161
MCC-16438, CSOM230DUS23T
Yes
Not Provided
Not Provided
H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Research Institute
Novartis Pharmaceuticals
Principal Investigator: Jonathan Strosberg, M.D. H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Research Institute
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP