NCT04852367: PanDox

PanDox: Targeted Doxorubicin in Pancreatic Tumours

Withdrawn Phase 1 Last updated 12 April 2023

What this trial tests

Phase 1 trial testing Focused Ultrasound in Pancreatic Ductal Adenocarcinoma. Withdrawn.

Timeline

16 June 2021

Primary endpoint
30 March 2023

30 March 2023

Quick facts

Lead sponsor	University of Oxford
Phase	Phase 1
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	basic science
Start date	16 June 2021
Primary completion	30 March 2023
Estimated completion	30 March 2023
Sites	1 location across United Kingdom

Drugs / interventions tested

• Focused Ultrasound
• Doxorubicin (doxorubicin) — full drug profile →
• ThermoDox — full drug profile →

Conditions studied

• Pancreatic Ductal Adenocarcinoma — all drugs for Pancreatic Ductal Adenocarcinoma →
• Pancreatic Cancer Stage IV — all drugs for Pancreatic Cancer Stage IV →
• Pancreatic Cancer Non-resectable — all drugs for Pancreatic Cancer Non-resectable →
• Pancreatic Cancer Metastatic — all drugs for Pancreatic Cancer Metastatic →

Sponsor

University of Oxford

Who can join

18 and older, any sex, with Pancreatic Ductal Adenocarcinoma or Pancreatic Cancer Stage IV. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Nanoparticles in the clinic: An update post COVID-19 vaccines.
   Anselmo AC, Mitragotri S. · · 2021 · cited 211× · PMID 34514159 · DOI 10.1002/btm2.10246
2. Cancer nanotechnology: current status and perspectives.
   Kemp JA, Kwon YJ. · · 2021 · cited 117× · PMID 34727233 · DOI 10.1186/s40580-021-00282-7
3. Thermosensitive Polymers and Thermo-Responsive Liposomal Drug Delivery Systems.
   Abuwatfa WH, Awad NS, Pitt WG, Husseini GA. · · 2022 · cited 50× · PMID 35267747 · DOI 10.3390/polym14050925
4. Physically stimulus-responsive nanoparticles for therapy and diagnosis.
   Farjadian F, Ghasemi S, Akbarian M, Hoseini-Ghahfarokhi M, et al · · 2022 · cited 31× · PMID 36186605 · DOI 10.3389/fchem.2022.952675
5. The translational paradigm of nanobiomaterials: Biological chemistry to modern applications.
   Sinha A, Simnani FZ, Singh D, Nandi A, et al · · 2022 · cited 27× · PMID 36310541 · DOI 10.1016/j.mtbio.2022.100463
6. Pharmacokinetic behaviors of soft nanoparticulate formulations of chemotherapeutics.
   Sarkar M, Wang Y, Ekpenyong O, Liang D, et al · · 2023 · cited 20× · PMID 35979879 · DOI 10.1002/wnan.1846
7. A landscape of recent advances in lipid nanoparticles and their translational potential for the treatment of solid tumors.
   Paun RA, Jurchuk S, Tabrizian M. · · 2024 · cited 18× · PMID 38435821 · DOI 10.1002/btm2.10601
8. Clinical trial protocol for PanDox: a phase I study of targeted chemotherapy delivery to non-resectable primary pancreatic tumours using thermosensitive liposomal doxorubicin (ThermoDox®) and focused ultrasound.
   Spiers L, Gray M, Lyon P, Sivakumar S, et al · · 2023 · cited 14× · PMID 37741968 · DOI 10.1186/s12885-023-11228-z