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131I-IPA and Concurrent XRT in Recurrent GBM

NCT03849105 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-04-14

No results posted yet for this study

Summary

A multi-centre, open-label, single-arm, dose-finding phase I/II study to evaluate safety, tolerability, dosing schedule, and preliminary efficacy of carrier-added 4-L-\[131I\]iodo-phenylalanine (131I-IPA), administered as single or repetitive injections in patients with recurrent glioblastoma multiforme (GBM), concomitantly to 2nd line external radiation therapy (XRT) - IPAX-1

Conditions

Interventions

RADIATION

4-L-[131I]iodo-phenylalanine (131I-IPA)

Study participants will receive by intravenous infusion an escalating activity of 4-L-\[131I\]iodo-phenylalanine (131I-IPA). Additional therapy is received in the form of externally administered radiotherapy

Sponsors & Collaborators

  • Telix Pharmaceuticals (Innovations) Pty Limited

    lead INDUSTRY

Principal Investigators

  • Josef Pichler, MD · Kepler University Clinic, Linz, Austria

  • Tatjana Traub-Weidinger · Medical University of Vienna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-09
Primary Completion
2022-07-31
Completion
2022-10-31

Countries

  • Australia
  • Austria
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

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 NCT03849105 on ClinicalTrials.gov