NCT05198479

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2023

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
1.3 years until next milestone

Study Start

First participant enrolled

May 5, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

October 11, 2023

Status Verified

October 1, 2023

Enrollment Period

1.7 years

First QC Date

January 6, 2022

Last Update Submit

October 9, 2023

Conditions

Metastatic Nasopharyngeal Cancer

Keywords

Peptide Receptor Radionuclide therapy (PRRT)177Lu-DOTA0-Tyr3-OctreotateRadionuclide therapyMetastatic Nasopharyngeal CarcinomaTheragnostics

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival (PFS).

    PFS is defined as the time from the date of initiating study treatment to the date of documented disease progression as determined by RECIST Criteria, Version 1.1 or death from any cause. Point estimates for median PFS and PFS rate at 6 month, with corresponding 95% Confidence Intervals (CIs), will be estimated using the Kaplan-Meier method.

    Within 76 weeks of start of study treatment.

Secondary Outcomes (3)

  • Objective Response Rate (ORR).

    Within 76 weeks of start of study treatment.

  • Time to Tumour Progression (TTP)

    Within 76 weeks of start of study treatment.

  • Overall Survival (OS).

    Within 76 weeks of start of study treatment.

Study Arms (1)

Arm 177 Lu-DOTA0-Tyr3-Octreotate

EXPERIMENTAL

Treatment with 177Lu-DOTATATE 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.

Radiation: 77 Lu-DOTA0-Tyr3-Octreotate

Interventions

77 Lu-DOTA0-Tyr3-OctreotateRADIATION

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.

Arm 177 Lu-DOTA0-Tyr3-Octreotate

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • a histologically confirmed diagnosis of NPC
  • metastatic 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

You may not qualify if:

  • 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.
  • Hb concentration \<5.0 mmol/L (\<8.0 g/dL); WBC \<3x10\^9/L (3000/mm3); platelets \<75x10\^9/L (75x10\^3/mm3).
  • Total bilirubin \>3 x ULN.
  • Serum albumin \<3.0 g/dL unless prothrombin time is within the normal range.
  • Pregnancy (see protocol Appendix 6).
  • For female patients of childbearing potential (defined as \< 2 years after last menstruation and not surgically sterile) and male patients, who are not surgically sterile or with female partners of childbearing potential: absence of effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal gel) as defined in Appendix 6.
  • Peptide receptor radionuclide therapy (PRRT) at any time prior to enrolment in the study.
  • Targeted surgery, radiotherapy (external beam), chemotherapy, embolization, interferons, mTOR-inhibitors or other investigational therapy within 3 weeks prior to enrolment in the study.
  • Known brain metastases, unless these metastases have been treated and stabilized for at least 24 weeks, prior to enrolment in the study. Patients with a history of brain metastases should have a head CT/MRI to document stable disease prior to enrolment in the study.
  • Uncontrolled congestive heart failure (NYHA II, III, IV).
  • Uncontrolled diabetes mellitus as defined by a fasting blood glucose \>2 ULN.
  • Any patient receiving treatment with short or long acting somatostatin analogs.
  • Patients with any other significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with completion of the study.
  • Urinary incontinence.
  • Other known co-existing malignancies except non-melanoma skin cancer and carcinoma in situ of the uterine cervix, unless definitively treated and proven no evidence of recurrence for 5 years.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Cancer Centre Singapore

Singapore, Singapore

RECRUITING

Singapore General Hospital

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal NeoplasmsNasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Daniel Tan, BSc, MBBS, PhD

    National Cancer Centre, Singapore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Tan, BSc, MBBS, PhD

CONTACT

+65 6436 8000daniel.tan.s.w@singhealth.com.sg

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2022

First Posted

January 20, 2022

Study Start

May 5, 2023

Primary Completion

December 31, 2024

Study Completion

September 30, 2025

Last Updated

October 11, 2023

Record last verified: 2023-10

Locations

SG(2)