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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01364415
First Posted: June 2, 2011
Last Update Posted: June 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
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: 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)

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

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 ]
    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 ]
    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).


Enrollment: 29
Study Start Date: August 2011
Study Completion Date: April 2016
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

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


Locations
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
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01364415     History of Changes
Other Study ID Numbers: CSOM230D2101
First Submitted: May 18, 2011
First Posted: June 2, 2011
Last Update Posted: June 28, 2016
Last Verified: June 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
MTD
pasireotide
LAR
NETs
advanced neuroendocrine tumors

Additional relevant MeSH terms:
Neuroendocrine Tumors
Carcinoid Tumor
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Pasireotide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs