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

Not Recruiting

Trial ID: NCT02705313


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.

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

Stanford Investigator(s)

Guido A. Davidzon
Guido A. Davidzon

Clinical Associate Professor, Radiology - Rad/Nuclear Medicine

George A. Fisher Jr.
George A. Fisher Jr.

Colleen Haas Chair in the School of Medicine

Andrei Iagaru
Andrei Iagaru

Professor of Radiology (Nuclear Medicine)


Inclusion Criteria:

   - 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)

Exclusion Criteria:

   - 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

   - 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

   - Patients who have not provided a signed informed consent form to accept this


drug: 177Lu-DOTA0-Tyr3-Octreotate

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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