Expanded Access Protocol for Therapeutic Use of 177Lu-DOTA0-Tyr3-Octreotate in Patients With Inoperable, Somatostatin Receptor Positive, Neuroendocrine Tumors, Progressive Under Somatostatin Analogue Therapy

Status: Approved for marketing
Location: See all (41) locations...
Intervention Type: Drug
Study Type: Expanded Access
SUMMARY

Advanced Accelerator Applications is currently pursuing marketing approval for 177Lu-DOTA0-Tyr3-Octreotate (Lutathera). This expanded access therapeutic protocol aims to allow patients suffering from inoperable, somatostatin receptor positive, neuroendocrine tumors, progressive under somatostatin analogue therapy to access the investigational product, 177Lu-DOTA0-Tyr3-Octreotate (Lutathera), prior to its commercial availability.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
View:

• Presence of metastasized or locally advanced neuroendocrine tumor, inoperable (curative intent) at enrollment time, and regardless of the origin of the tumor.

• Ki67 index ≤ 20%

• Patients progressive under SSA (any dose) at the time of enrollment

• Target lesions over-expressing somatostatin receptors according to an appropriate imaging method (e.g. 111In-pentetreotide (Octreoscan) imaging or 68Ga-DOTA0-Tyr3-Octreotate (or 68Ga-edotreotide) imaging)

Locations
United States
Arizona
Banner M.D. Anderson Cancer Center
Gilbert
Mayo Clinic Hospital
Phoenix
California
City of Hope (City of Hope Medical Center, City of Hope National Medical Center)
Duarte
University of California, Los Angeles
Los Angeles
University of California, San Francisco
San Francisco
Kaiser Permanente, Santa Clara Homestead
Santa Clara
Stanford University Medical Center
Stanford
Colorado
University of Colorado Hospital - Anschutz Cancer Pavilion
Aurora
Rocky Mountain Cancer Centers
Denver
Florida
Mayo Clinic
Jacksonville
Moffitt Cancer Center
Tampa
Georgia
Emory University Hospital
Atlanta
Cancer Treatment Center of America - Southeastern Regional Medical Center
Newnan
Iowa
The University of Iowa Hospitals & Clinics (UIHC) including the Carver College of Medicine
Iowa City
Illinois
Northwestern Medicine
Chicago
Rush University Medical Center
Chicago
Louisiana
Ochsner Medical Center
Kenner
Massachusetts
Dana-Farber Cancer Institute
Boston
Maryland
Johns Hopkins Outpatient Center
Baltimore
Michigan
Karmanos Cancer Institute
Detroit
Minnesota
Mayo Clinic
Rochester
Missouri
Kansas City Research Institute
Kansas City
Washington University School of Medicine Siteman Cancer Center
Saint Louis
North Carolina
Duke University Hospital
Durham
Nebraska
CHI Health West Omaha Imaging Center
Omaha
New York
Montefiore Einstein Center for Cancer Care
Bronx
Roswell Park Cancer Institute
Buffalo
Icahn School of Medicine at Mount Sinai
New York
Lenox Hill Hospital
New York
Memorial Sloan Kettering Cancer Center
New York
Stony Brook Cancer Center
Stony Brook
Ohio
The Ohio State University James Cancer Center
Columbus
Pennsylvania
Fox Chase Cancer Center
Philadelphia
University of Pittsburgh, Medical Center
Pittsburgh
South Carolina
Bon Secours Medical Group/ Saint Francis Hospital Cancer Center
Greenville
Texas
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas
UT Southwestern Medical Center
Dallas
Utah
University of Utah, Huntsman Cancer Institute
Salt Lake City
Virginia
Carilion Clinic
Roanoke
Washington
University of Washington, Department of Radiology, Division of Nuclear Medicine
Seattle
Virginia Mason Medical Center
Seattle
Authors
Related Therapeutic Areas
Sponsors
Leads: Advanced Accelerator Applications

This content was sourced from clinicaltrials.gov

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