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

PHASE2RecruitingINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

May 5, 2023

Primary Completion Date

December 31, 2024

Study Completion Date

September 30, 2025

Conditions
Metastatic Nasopharyngeal Cancer
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.

Trial Locations (2)

Unknown

RECRUITING

National Cancer Centre Singapore, Singapore

RECRUITING

Singapore General Hospital, Singapore

All Listed Sponsors
collaborator

Novartis

INDUSTRY

collaborator

Advanced Accelerator Applications

INDUSTRY

lead

National Cancer Centre, Singapore

OTHER