A Clinical Study of Lutetium[177Lu] Oxodotreotide Injection in Patients With Advanced Neuroendocr… (NCT06398444) | Clinical Trial Compass
Active — Not RecruitingPhase 2/3
A Clinical Study of Lutetium[177Lu] Oxodotreotide Injection in Patients With Advanced Neuroendocrine Neoplasms
China74 participantsStarted 2024-06-11
Plain-language summary
This is a multicenter, single-arm, two-part study designed to evaluate the safety and efficacy of Lutetium \[177Lu\] Oxyoctreotide Injection in patients with inoperable, locally advanced or metastatic, progressive, advanced somatostatin receptor (SSTR) positive neuroendocrine neoplasms (NEN) other than grade G1/G2 gastroenteropancreatic neuroendocrine tumors (GEP-NET).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Able to understand and have willingness to provide a written informed consent document.
✓. Aged 18 years or older.
✓. ECOG performance status 0 or 1.
✓. Histopathologically confirmed, unresectable locally advanced or metastatic NEN .
✓. Disease progression before first dose.
✓. Subjects of childbearing potential should voluntarily use an effective method of contraception during treatment and within 4 months (male) or 7 months (female) of the last dose.
Exclusion criteria
✕. Known brain metastases, unless these metastases have been treated and stabilized for at least 24 weeks prior to enrollment in the study.
✕. Uncontrolled congestive heart failure, including baseline left ventricular ejection fraction (LVEF) \<50%.
✕. Uncontrolled diabetes mellitus, including baseline fasting glucose \> 2 x ULN.
✕. Any clinically significant active infection.
✕. Pregnant or lactating females.
✕. Received systemic antitumor therapy such as targeted therapy, immunotherapy, antitumor herbal therapy or chemotherapy within 4 weeks prior to enrollment.
✕
What they're measuring
1
Incidence and severity of adverse events (AE) (Part1)
. Known other malignancies (except for those without recurrence within 5 years after adequate treatment).
✕. Any other disease, mental status or surgical condition that is uncontrolled, may interfere with study completion (including poor compliance) or is inappropriate for the use of the investigational drug.