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A Phase I, Multi-center, Open-label, Dose Escalation Study of Pasireotide (SOM230) LAR in Patients With Advanced Neuroendocrine Tumors (NETs)


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Neuroendocrine Tumors

Thank you

Trial Information

A Phase I, Multi-center, Open-label, Dose Escalation Study of Pasireotide (SOM230) LAR in Patients With Advanced Neuroendocrine Tumors (NETs)


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the MTD/RP2D of pasireotide LAR when administered i.m. q28 days to patients with advanced NETs

Outcome Description:

Frequency of dose-limiting toxicities (DLTs) at each dose level associated with q28 days administration of pasireotide LAR during the first 2 treatment cycles.

Outcome Time Frame:

Sequentiona 56 day cohorts until the MTD is determined

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CSOM230D2101

NCT ID:

NCT01364415

Start Date:

August 2011

Completion Date:

January 2014

Related Keywords:

  • Neuroendocrine Tumors
  • MTD
  • pasireotide
  • LAR
  • NETs
  • advanced neuroendocrine tumors
  • Neuroendocrine Tumors

Name

Location
H. Lee Moffitt Cancer Center/University of South Florida SC-1 Tampa, Florida  33612
Dana Farber Cancer Institute SC-6 Boston, Massachusetts  02115
MD Anderson Cancer Center/University of Texas UT MD Anderson Cancer Ctr Houston, Texas  77030-4009
Cedars Sinai Medical Center Cedars Sinai 4 Los Angeles, California  90048