Study of Pasireotide Long Acting Release (LAR) in Patients With Metastatic Neuroendocrine Tumors (NETs)
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ClinicalTrials.gov Identifier: NCT01253161 |
Recruitment Status :
Active, not recruiting
First Posted : December 3, 2010
Last Update Posted : February 16, 2021
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Condition or disease | Intervention/treatment | Phase |
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Neuroendocrine Tumors Carcinoid Tumors | Drug: Pasireotide Long Acting Release (LAR) | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 29 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Study of Pasireotide LAR in Patients With Metastatic Neuroendocrine Carcinomas |
Actual Study Start Date : | February 1, 2011 |
Estimated Primary Completion Date : | July 2021 |
Estimated Study Completion Date : | December 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Pasireotide LAR Treatment
The investigational drug used in this study is pasireotide long acting release (LAR) 60 mg.
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Drug: Pasireotide Long Acting Release (LAR)
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.
Other Name: SOM 230 |
- Rate of Progression-free Survival (PFS) at One Year [ Time Frame: 12 months ]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.
- Median Overall Survival (OS) [ Time Frame: Up to 48 months ]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 ]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 ]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).

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01253161
United States, California | |
Stanford Cancer Institute | |
Stanford, California, United States, 94305 | |
United States, Florida | |
H. Lee Moffitt Cancer Center and Research Institute | |
Tampa, Florida, United States, 33612 |
Principal Investigator: | Jonathan Strosberg, M.D. | H. Lee Moffitt Cancer Center and Research Institute |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | H. Lee Moffitt Cancer Center and Research Institute |
ClinicalTrials.gov Identifier: | NCT01253161 |
Other Study ID Numbers: |
MCC-16438 CSOM230DUS23T ( Other Identifier: Novartis Pharmaceuticals ) |
First Posted: | December 3, 2010 Key Record Dates |
Last Update Posted: | February 16, 2021 |
Last Verified: | December 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
advanced metastatic unresectable carcinoma gastrointestinal tract lungs |
colon liver rectum small intestine stomach pancreatic |
Neoplasms Neuroendocrine Tumors Carcinoid Tumor Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Nerve Tissue |
Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Pasireotide Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |