Phase II 177Lu-DOTATATE Study in Metastatic NPC With a Safety Run-in
- Trial number:
- NCT05198479
- Trial phase:
- 2
- Study type:
- Any
- Overall status:
- Not yet recruiting
Study start date
Scientific title
Summary
a histologically confirmed diagnosis of NPCmetastatic NPC that has failed two or more lines of therapy or exhausted standard therapy an Eastern Cooperative Oncology Group performance status of 0-2 age 21-75 years, a life expectancy of more than 3 months no prior use of radionuclide therapy no prior radiotherapy to more than 25% of bone marrow less than 50% of bone marrow involved on 68Ga-DOTATATE scan Krenning score ≥ 3 and at least 75% concordance between 68Ga-DOTATATE scan and 18F-FDG PET scan at least 1 bidimensionally measurable (2 cm) site of disease. A wash-out period of at least 3 weeks from the last dose of prior chemotherapy is required before the administration of the first dose of 177Lu-DOTATATE. adequate hematologic, renal, and liver function using standard laboratory measurements no history of other malignancy, except treated basal cell and squamous cell skin carcinomas