EAP 177Lu-DOTA0-Tyr3-Octreotate for Inoperable, SSR+, NETs, Progressive Under SSA Tx

APPROVED_FOR_MARKETING

Conditions studied: Neuroendocrine Tumors

In brief

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.

Key facts

Study ID

NCT02705313

Run by

Advanced Accelerator Applications

Last updated by the study team

2018-04-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• Either serum creatinine >150 μmol/L (>1.7 mg/dL), or creatinine clearance <50 mL/min calculated by the Cockroft Gault method, eventually confirmed by measured creatinine clearance (or measured glomerular filtration rate (GFR) using plasma clearance methods, not gamma camera-based) <50 mL/min (the measured creatinine clearance / GFR is required only as confirmatory exam).
• Hb concentration <5.0 mmol/L (<8.0 g/dL); WBC <2x109/L (2000/mm3); platelets <75x109/L (75x103/mm3).
• Total bilirubin >3 x ULN.
• Serum albumin <3.0 g/dL unless prothrombin time is within the normal range.
• Pregnancy or lactation.
• For female patients of childbearing potential (defined as < 2 years after last menstruation and not surgically sterile) and male patients, who are not surgically sterile or with female partners of childbearing potential: absence of effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal gel).
• Any surgery, radioembolization, chemoembolization, chemotherapy and radiofrequency ablation within 12 weeks prior to enrollment.
• Interferons, Everolimus (mTOR-inhibitors) or other systemic therapies within 4 weeks prior to enrollment.
• Known brain metastases, unless these metastases have been treated and stabilized.
• Uncontrolled congestive heart failure (NYHA II, III, IV).
• Uncontrolled diabetes mellitus as defined by a fasting blood glucose >2 ULN.
• Any patient receiving treatment with short-acting Octreotide, which cannot be interrupted for 24 h before and 24 h after the administration of 177Lu-DOTA0-Tyr3-Octreotate, or any patient receiving treatment with Octreotide LAR, which cannot be interrupted for at least 4 weeks before the administration of 177Lu-DOTA0-Tyr3-Octreotate, unless the tumor uptake on target lesions is at least as high as normal liver uptake.
• Patients with any other significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may pose a risk to the patient safety
• Prior external beam radiation therapy to more than 25% of the bone marrow.
• Current spontaneous urinary incontinence making impossible the safe administration of the radioactive IMP.
• Other known co-existing malignancies except non-melanoma skin cancer and carcinoma in situ of the uterine cervix, unless definitively treated and with no evidence of recurrence.
• Patients who have not provided a signed informed consent form to accept this treatment.

Where it is running

• 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 — St Louis, Missouri, United States
• CHI Health West Omaha Imaging Center — Omaha, Nebraska, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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