Dose Escalation Study of Pasireotide (SOM230) in Patients With Advanced Neuroendocrine Tumors (NETs)
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ClinicalTrials.gov Identifier: NCT01364415 |
Recruitment Status :
Completed
First Posted : June 2, 2011
Last Update Posted : June 28, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Neuroendocrine Tumors | Drug: Pasireotide LAR | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 29 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I, Multi-center, Open-label, Dose Escalation Study of Pasireotide (SOM230) LAR in Patients With Advanced Neuroendocrine Tumors (NETs) |
Study Start Date : | August 2011 |
Actual Primary Completion Date : | April 2016 |
Actual Study Completion Date : | April 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: Pasireotide LAR |
Drug: Pasireotide LAR
Other Name: SOM230 |
- Determine the MTD/RP2D of pasireotide LAR when administered i.m. q28 days to patients with advanced NETs [ Time Frame: Sequentiona 56 day cohorts until the MTD is determined ]Frequency of dose-limiting toxicities (DLTs) at each dose level associated with q28 days administration of pasireotide LAR during the first 2 treatment cycles.
- assess the safety and tolerability of pasireotide LAR [ Time Frame: minimum of twelve 28 day cycles to approximately eighteen 28 day cycles ]Incidence of adverse drug events, overall and by severity and incidence of serious adverse events and laboratory abnormalities. Also, changes in laboratory assessments, electrocardiograms, Holter monitor, imaging for gallstones, and assessment of physical examinations such as vital signs
- assess the pharmacokinetics (PK) of pasireotide LAR [ Time Frame: minimum of twelve 28 day cycles to approximately eighteen 28 day cycles ]Pasireotide Cmax and Ctrough
- assess the pharmacodynamics (PD) of pasireotide LAR [ Time Frame: minimum of twelve 28 day cycles to approximately eighteen 28 day cycles ]Changes from baseline values in IGF-1, chromogranin A and neuron-specific enolase
- assess the preliminary efficacy (anti-tumor activity) of pasireotide LAR. [ Time Frame: minimum of twelve 28 day cycles to approximately eighteen 28 day cycles ]Disease control rate (CR+PR+SD as assessed by RECIST 1.0). Also measure progression free survival (PFS).

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- ≥18 yrs old, histologically confirmed advanced well or moderately differentiated neuroendocrine tumor/carcinoma
- unresectable metastatic NET tumor with measurable disease
- life expectancy ≥ 12 weeks
Exclusion Criteria:
- Patients with CNS metastases who are neurologically unstable or requiring increasing doses of steroids to control their CNS disease
- patients with known hypersensitivity to somatostatin analogs
- patients with symptomatic cholelithiasis in the past 2 months
- patients with history of another known primary malignancy with exception of non-melanoma skin cancer or carcinoma in situ of uterine cervix
- patients with known history of hepatitis C or chronic active hepatitis B
- patients with diagnosis of HIV.
Other protocol-defined inclusion/exclusion criteria may apply

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): NCT01364415
United States, California | |
Cedars Sinai Medical Center Cedars Sinai 4 | |
Los Angeles, California, United States, 90048 | |
United States, Florida | |
H. Lee Moffitt Cancer Center & Research Institute SC-1 | |
Tampa, Florida, United States, 33612 | |
United States, Massachusetts | |
Dana Farber Cancer Institute SC-6 | |
Boston, Massachusetts, United States, 02215 | |
United States, Texas | |
University of Texas/MD Anderson Cancer Center UT MD Anderson Cancer Ctr | |
Houston, Texas, United States, 77030-4009 |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT01364415 History of Changes |
Other Study ID Numbers: |
CSOM230D2101 |
First Posted: | June 2, 2011 Key Record Dates |
Last Update Posted: | June 28, 2016 |
Last Verified: | June 2016 |
MTD pasireotide LAR NETs advanced neuroendocrine tumors |
Neuroendocrine Tumors Neoplasms Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type |
Neoplasms, Nerve Tissue Pasireotide Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |