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Phase I Trial of Vandetanib Combined With 131I-mIBG to Treat Patients With Advanced Phaeochromocytoma and Paraganglioma

NCT01941849 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2015-12-21

No results posted yet for this study

Summary

The phase I trial aims to determine the recommended phase II dose (RP2D) of vandetanib in combination with standard radiation therapy, 131I-mIBG, in patients with advanced phaeochromocytoma (phaeo) and paraganglioma (PG) by assessing the safety and tolerability of the combination treatment.

Conditions

  • Phaeochromocytoma
  • Paraganglioma

Interventions

DRUG

Vandetanib

100 mg, 200 mg or 300 mg taken once a day during each 12-weekly cycle

RADIATION

131I-mIBG

Activity will be prescribed to deliver whole body absorbed dose of 0.5 Gy (+/-10%)

Sponsors & Collaborators

Principal Investigators

  • Christina Thirlwell · University College London (UCL) Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United Kingdom

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 NCT01941849 on ClinicalTrials.gov