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

NCT05198479 · Status: SUSPENDED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-05-22

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Advanced Accelerator Applications

    collaborator INDUSTRY

  • National Cancer Centre, Singapore

    lead OTHER

Principal Investigators

  • Daniel Tan, BSc, MBBS, PhD · National Cancer Centre, Singapore

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-05
Primary Completion
2026-12-31
Completion
2027-09-30

Countries

  • Singapore

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05198479 on ClinicalTrials.gov