Clinical Trial · NCT05198479

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

Overview

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.

Sponsor

National Cancer Centre, Singapore

Phase

Phase 2

Contacts

Daniel Tan, BSc, MBBS, PhD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT05198479

Eligibility

Inclusion

metastatic NPC that has failed two or more lines of therapy or exhausted standard therapy
age 21-75 years, a life expectancy of more than 3 months
* a histologically confirmed diagnosis of NPC
an Eastern Cooperative Oncology Group performance status of 0-2
no prior use of radionuclide therapy

Exclusion

Hb concentration \<5.0 mmol/L (\<8.0 g/dL); WBC \<3x10\^9/L (3000/mm3); platelets \<75x10\^9/L (75x10\^3/mm3).
Pregnancy (see protocol Appendix 6).
Serum albumin \<3.0 g/dL unless prothrombin time is within the normal range.
Total bilirubin \>3 x ULN.
* Serum creatinine \>120 μmol/L or 1.2 mg/dL, or a measured creatinine clearance (or measured glomerular filtration rate (GFR) using plasma clearance methods, not gamma camera-based) of \<50 mL/min.