USO 24285
A phase III multi-center, randomized, open-label study to evaluate the efficacy and safety of [177Lu]Lu-DOTA-TATE in patients newly diagnosed with Grade 1 and Grade 2 (Ki-67 <10%) advanced GEP-NET with high disease burden (NETTER-3) Protocol No.: CAAA601A62301
Tipos de enfermedades: Investigación sobre el cáncer gastrointestinal
Requisitos de elegibilidad:
• Subjects must have metastasized or locally advanced, unresectable
histologically proven, well differentiated G1 or G2 (Ki-67 <10%) GEPNET diagnosed within 6 months prior to screening
• Subjects must have high disease burden (see inclusion criteria for
guiding principle for determining high disease burden)
• RLI SSTR uptake in all target lesions ≥ liver within 3 months of
randomization
• Subjects that have received any previous therapy with interferons,
mTOR-inhibitors, chemotherapy or other systemic therapies are
excluded
• Subjects with prior administration of a therapeutic radiopharmaceutical
for GEP-NET at any time prior to randomization are excluded
• Participant who received more than 4 cycles of prior SSA (e.g.,
octreotide LAR) are not eligible
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