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SUSPENDED
NCT05198479
PHASE2

Phase II 177Lu-DOTATATE Study in Metastatic NPC With a Safety Run-in

Sponsor: National Cancer Centre, Singapore

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

21 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2023-05-05

Completion Date

2027-09-30

Last Updated

2026-05-22

Healthy Volunteers

No

Interventions

RADIATION

77 Lu-DOTA0-Tyr3-Octreotate

Treatment will consist of a cumulative dose of 23.68 - 29.6 GBq (640 - 800 mCi) 177Lu-DOTA0 -Tyr3-Octreotate; Four administrations of 5.92 - 7.4 GBq (160 - 200 mCi) 177Lu-DOTA0-Tyr3-Octreotate; Concomitant amino acids will be given with each administration for kidney protection; 177Lu-DOTA0-Tyr3-Octreotate will be administered at 8±1-week intervals, which can be extended up to 16 weeks to accommodate resolving acute toxicity.

Locations (2)

National Cancer Centre Singapore

Singapore, Singapore

Singapore General Hospital

Singapore, Singapore