Dose Escalation Study of Pasireotide (SOM230) in Patients With Advanced Neuroendocrine Tumors (NETs) - Full Text View

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:

MedlinePlus related topics: Cancer

Drug Information available for: Pasireotide

U.S. FDA Resources

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:	January 2014
Estimated Primary Completion Date:	January 2014 (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

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

Contacts

Contact: Novartis Pharmaceuticals

+1(800)340-6843

Locations

United States, California
Cedars Sinai Medical Center Cedars Sinai 4	Recruiting
Los Angeles, California, United States, 90048
Contact: Koty Nadeau 310-423-1047 koty.nadeau@cshs.org
Principal Investigator: Edward M. Wolin
United States, Florida
H. Lee Moffitt Cancer Center/University of South Florida 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: Susan Sheehan 617-724-4000 SSheehan1@Partners.org
Contact: Eileen Regan +1 617-724-4000 ERegan@partners.org
Principal Investigator: Jennifer Chan
United States, Texas
MD Anderson Cancer Center/University of Texas UT MD Anderson Cancer Ctr	Recruiting
Houston, Texas, United States, 77030-4009
Contact: Gail Bland 713-745-3246 gbland@mdanderson.org
Principal Investigator: Alexandria Phan

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

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:	January 8, 2013
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 May 19, 2013