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A Phase II, International Open Label Trial of Minnelide™ in Patients With Refractory Pancreatic Cancer

NCT03117920 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2023-10-18

No results posted yet for this study

Summary

MinPAC aims to see if the drug Minnelide can slow down tumour growth in patients with pancreatic cancer that is not responding to treatment. Minnelide is designed to rapidly release the anti-tumour molecule triptolide in the bloodstream and has been shown to slow cancer cell growth and induce cancer cell death. Minnelide is currently being investigated in other early phase trials and has shown promising response data.

There are strict eligibility criteria for this trial. Broadly speaking, patients with pancreatic cancer that has spread to other organs and has progressed on one or more chemotherapy regimens are eligible. Participants will receive Minnelide on days 1-21 of each 28 day cycle until their cancer stops responding to treatment. After that participants will be followed up 3 monthly for the collection of disease status and survival data.

MinPAC includes biological and imaging studies. Participants will be asked to donate tumour and blood samples and will be asked to undergo additional PET Scans. The study is being carried out in 4 sites in the UK and USA.

Conditions

Interventions

DRUG

Minnelide

Minnelide will be administered at the dose of 0.67 mg/m2 as a 30 min infusion intravenously daily on days 1-21 of each cycle followed by a 7 day rest period (days 22-28).

Sponsors & Collaborators

  • Barts & The London NHS Trust

    collaborator OTHER

  • Translational Genomics Research Institute

    collaborator OTHER

  • Stand Up To Cancer

    collaborator OTHER

  • Cancer Research UK

    collaborator OTHER

  • Lustgarten Foundation

    collaborator OTHER

  • Queen Mary University of London

    collaborator OTHER

  • Minneamrita Therapeutics LLC

    lead INDUSTRY

Principal Investigators

  • David Propper · Barts & The London NHS Trust

  • Erkut Borazanci · HonorHealth Research 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
2017-04-10
Primary Completion
2019-07-01
Completion
2019-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
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 NCT03117920 on ClinicalTrials.gov