⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for EAP 177Lu-DOTA0-Tyr3-Octreotate for Inoperable, SSR+, NETs, Progressive Under SSA Tx

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

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

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: