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

May, 2023

Scientific title

A Biomarker Enrichment, Phase II Study of 177Lu-DOTATATE in Metastatic Nasopharyngeal Cancer With a Safety Run-in

Summary

This study is the first phase II study of 177Lu-DOTA0-Tyr3-Octreotate in metastatic NPC. Patients whom have failed 2 or more lines of therapy or exhausted standard therapy and are avid on 68Ga-DOTATATE imaging will be eligible to receive up to 4 cycles of 177Lu-DOTA0-Tyr3-Octreotate. The primary outcome will be progression free survival at 6 months.

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

Study design

Primary purpose: Treatment, Allocation: N/A, Intervention model: Single Group Assignment, Masking: None (Open Label),

Conditions

Metastatic Nasopharyngeal Cancer

Other study ID numbers

SG-AAA-II-01

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