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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01364415
First received: May 18, 2011
Last updated: March 19, 2014
Last verified: March 2014
  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: 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).


Estimated Enrollment: 42
Study Start Date: August 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pasireotide LAR Drug: Pasireotide LAR
Other Name: SOM230

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01364415

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

Locations
United States, California
Cedars Sinai Medical Center Cedars Sinai 4 Recruiting
Los Angeles, California, United States, 90048
Contact: Julie Illi    310-423-1047    julie.illi@cshs.org   
Principal Investigator: Edward M. Wolin         
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute SC-1 Recruiting
Tampa, Florida, United States, 33612
Contact: Kesia Engel    813-745-4740    kesia.engel@moffitt.org   
Principal Investigator: Jonathan Strosberg         
United States, Massachusetts
Dana Farber Cancer Institute SC-6 Recruiting
Boston, Massachusetts, United States, 02115
Contact: David Harris    +1 617 632 6746    dharris9@mgh.harvard.edu   
Principal Investigator: Jennifer Ang Chan         
United States, Texas
University of Texas/MD Anderson Cancer Center UT MD Anderson Cancer Ctr Recruiting
Houston, Texas, United States, 77030-4009
Contact: Gail Bland    713-745-3246    gbland@mdanderson.org   
Principal Investigator: James C. Yao         
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01364415     History of Changes
Other Study ID Numbers: CSOM230D2101
Study First Received: May 18, 2011
Last Updated: March 19, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on July 29, 2014