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