Dose Escalation Study of Pasireotide (SOM230) in Patients With Advanced Neuroendocrine Tumors (NETs)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: May 18, 2011
Last updated: December 15, 2015
Last verified: December 2015
This study designed to determine the Maximum Tolerated Dose (MTD) for patients with advanced Neuroendocrine Tumors (NETs) and to characterize the safety, tolerability, Pharmacokinetics and preliminary efficacy of pasireotide LAR administered i.m. once every 28 days.

Condition Intervention Phase
Neuroendocrine Tumors
Drug: Pasireotide LAR
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    Frequency of dose-limiting toxicities (DLTs) at each dose level associated with q28 days administration of pasireotide LAR during the first 2 treatment cycles.

Secondary Outcome Measures:
  • assess the safety and tolerability of pasireotide LAR [ Time Frame: minimum of twelve 28 day cycles to approximately eighteen 28 day cycles ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Disease control rate (CR+PR+SD as assessed by RECIST 1.0). Also measure progression free survival (PFS).

Enrollment: 29
Study Start Date: August 2011
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pasireotide LAR Drug: Pasireotide LAR
Other Name: SOM230


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

  Contacts and Locations
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Please refer to this study by its identifier: 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
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis ( Novartis Pharmaceuticals ) Identifier: NCT01364415     History of Changes
Other Study ID Numbers: CSOM230D2101 
Study First Received: May 18, 2011
Last Updated: December 15, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
advanced neuroendocrine tumors

Additional relevant MeSH terms:
Carcinoid Tumor
Neuroendocrine Tumors
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neuroectodermal Tumors processed this record on May 30, 2016