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)

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)

Guido A. Davidzon
Guido A. Davidzon

Clinical Associate Professor, Radiology - Rad/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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