Spots Global Cancer Trial Database for EAP 177Lu-DOTA0-Tyr3-Octreotate for Inoperable, SSR+, NETs, Progressive Under SSA Tx
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Trial Identification
Brief Title: EAP 177Lu-DOTA0-Tyr3-Octreotate for Inoperable, SSR+, NETs, Progressive Under SSA Tx
Official Title: 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
Study ID: NCT02705313
Conditions
Interventions
Study Description
Brief 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.
Detailed Description: Advanced Accelerator Applications activated in 2012 a multicenter, stratified, open, randomized, comparator-controlled, parallel-group Phase III study comparing treatment with 177Lu-DOTA0-Tyr3-Octreotate to 60 mg Octreotide LAR in patients with inoperable, progressive, somatostatin receptor positive, midgut carcinoid tumors (NETTER-1 trial, EudraCT number 2011-005049-11, IND number 77219). Clinical studies, including NETTER-1 for which the primary analysis has been conducted, showed clinical evidence of safety and effectiveness to support the expanded access use without any unreasonable potential risks for the patients in the context of the disease to be treated. In July 2016, the first patient was treated under an Expanded Access Program (EAP) for inoperable, progressive, somatostatin receptor positive, midgut carcinoid tumors. Compassionate use programs in Europe include pulmonary NETs. In the US, there were many centers with patients with NETs who did not meet the inclusion criteria for the original EAP. In May 2017, Advanced Accelerator Applications inquired with the FDA if amending the inclusion criteria of the original protocol to include all NETs would be permissible. In June 2017, Advanced Accelerator Applications was able to submit a revision to the original Expanded Access Program's protocol for 177Lu-DOTA0-Tyr3-Octreotate to include neuroendocrine tumors arising from sites other than midgut. The locations listed below that are participating in the EAP may have received IRB approval for either the original protocol or the new protocol or both. Please, inquire with the Facility Contact as to which protocol is active at their site.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Banner M.D. Anderson Cancer Center, Gilbert, Arizona, United States
Mayo Clinic Hospital, Phoenix, Arizona, United States
City of Hope (City of Hope Medical Center, City of Hope National Medical Center), Duarte, California, United States
University of California, Los Angeles, Los Angeles, California, United States
University of California, San Francisco, San Francisco, California, United States
Kaiser Permanente, Santa Clara Homestead, Santa Clara, California, United States
Stanford University Medical Center, Stanford, California, United States
University of Colorado Hospital - Anschutz Cancer Pavilion, Aurora, Colorado, United States
Rocky Mountain Cancer Centers, Denver, Colorado, United States
Mayo Clinic, Jacksonville, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Emory University Hospital, Atlanta, Georgia, United States
Cancer Treatment Center of America - Southeastern Regional Medical Center, Newnan, Georgia, United States
Northwestern Medicine, Chicago, Illinois, United States
Rush University Medical Center, Chicago, Illinois, United States
The University of Iowa Hospitals & Clinics (UIHC) including the Carver College of Medicine, Iowa City, Iowa, United States
Ochsner Medical Center, Kenner, Louisiana, United States
Johns Hopkins Outpatient Center, Baltimore, Maryland, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Mayo Clinic, Rochester, Minnesota, United States
Kansas City Research Institute, Kansas City, Missouri, United States
Washington University School of Medicine Siteman Cancer Center, Saint Louis, Missouri, United States
CHI Health West Omaha Imaging Center, Omaha, Nebraska, United States
Montefiore Einstein Center for Cancer Care, Bronx, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Icahn School of Medicine at Mount Sinai, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Lenox Hill Hospital, New York, New York, United States
Stony Brook Cancer Center, Stony Brook, New York, United States
Duke University Hospital, Durham, North Carolina, United States
The Ohio State University James Cancer Center, Columbus, Ohio, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
University of Pittsburgh, Medical Center, Pittsburgh, Pennsylvania, United States
Bon Secours Medical Group/ Saint Francis Hospital Cancer Center, Greenville, South Carolina, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
UT Southwestern Medical Center, Dallas, Texas, United States
University of Utah, Huntsman Cancer Institute, Salt Lake City, Utah, United States
Carilion Clinic, Roanoke, Virginia, United States
Virginia Mason Medical Center, Seattle, Washington, United States
University of Washington, Department of Radiology, Division of Nuclear Medicine, Seattle, Washington, United States
Contact Details
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