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

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 (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.