PanDox: Targeted Doxorubicin in Pancreatic Tumours
NCT04852367 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL
Last updated 2023-04-12
Summary
This study will combine focused ultrasound to generate heat, and a heat-sensitive chemotherapy drug (ThermoDox®), delivered into the blood of participants with non-resectable pancreatic cancer. We will compare this to standard delivery of chemotherapy - the drug Doxorubicin given into the blood without the addition of ultrasound. We aim to determine whether the novel approach to delivering chemotherapy with heating the tumour by focused ultrasound can enhance the amount of drug delivered to pancreatic tumours. This will be measured by analysing a biopsy sample of treated tumour.
Conditions
- Pancreatic Ductal Adenocarcinoma
- Pancreatic Cancer Stage IV
- Pancreatic Cancer Non-resectable
- Pancreatic Cancer Metastatic
Interventions
- DEVICE
-
Focused Ultrasound
Focused ultrasound targetting the tumour at subablative powers, to facilitate drug release
- DRUG
-
Doxorubicin
Doxorubicin infusion
- DRUG
-
ThermoDox
ThermoDox infusion
Sponsors & Collaborators
-
National Institute for Health Research, United Kingdom
collaborator OTHER_GOV -
Imunon
collaborator INDUSTRY -
University of Oxford
lead OTHER
Principal Investigators
-
Mark Middleton · Consultant Medical Oncologist and Professor of Experimental Cancer Medicine
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-06-16
- Primary Completion
- 2023-03-30
- Completion
- 2023-03-30
Countries
- United Kingdom
Study Locations
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