A Phase II, International Open Label Trial of Minnelide™ in Patients With Refractory Pancreatic Cancer (MinPAC)
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|ClinicalTrials.gov Identifier: NCT03117920|
Recruitment Status : Recruiting
First Posted : April 18, 2017
Last Update Posted : September 14, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: Minnelide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single arm, open label study.|
|Masking:||None (Open Label)|
|Official Title:||MinPAC: A Phase II, International Open Label Trial of Minnelide™ in Patients With Refractory Pancreatic Cancer.|
|Actual Study Start Date :||April 10, 2017|
|Estimated Primary Completion Date :||May 15, 2018|
|Estimated Study Completion Date :||February 15, 2019|
0.67 mg/m2 Minnelide daily as a 30min iv infusion on days 1-21 of each 28 day cycle, followed by a 7 day rest period (D 22-28).
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).
- Disease Control rate (DCR) [ Time Frame: Enrolment to 16 weeks ]DCR (CR+PR+SD) by RECIST v1.1
- Progression Free Survival (PFS) [ Time Frame: Disease progression or death, assessed up to 18 months ]Time from enrolment until disease progression or death from any cause, whichever occurs first (RECIST v1.1)
- Incidence of adverse events [ Time Frame: Through completion of the safety visit an average of 4 months ]Adverse events by CTCAE v4.03
- Overall survival (OS) [ Time Frame: Death, assessed up to 18 months ]Time from enrolment until death
- Response rate (RR) [ Time Frame: Enrlolment to 16 weeks ]Percentage of individuals on study attaining a CR + PR (RECIST v1.1)
- Change in tumour size and volume [ Time Frame: Baseline to 8 weeks ]Change in the sum of diameters of the target lesions
- Change in CA19-9 levels [ Time Frame: Through completion of the treatment period an average of 4 months ]Percentage of patients with >20% decrease
- Pharmacodynamic effect of Minnelide on tumour using PET Scans [ Time Frame: 8 weeks ]Changes in SUV
- Biomarkers predictive of response to Minnelide [ Time Frame: Through completion of the treatment period an average of 4 months ]Changes in circulating tumour stem cells.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03117920
|Contact: MinPAC Trial Coordinatoremail@example.com|
|Contact: Kelly Mousafirstname.lastname@example.org|
|United States, Arizona|
|HonorHealth Research Institute||Recruiting|
|Scottsdale, Arizona, United States, 85258|
|Contact: Joyce Schaffer 480-323-1339 email@example.com|
|Principal Investigator: Erkut Borazanci|
|United States, California|
|Moores UC San Diego Cancer Center||Recruiting|
|La Jolla, California, United States, 92037|
|Contact: Michelle Mendoza 858-822-6937 firstname.lastname@example.org|
|Principal Investigator: Hitendra Patel, MD|
|United States, Pennsylvania|
|University of Pennsylvania||Not yet recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Peter O'Dwyer 215-360-0716|
|Principal Investigator: Peter O'Dwyer|
|Barts Health NHS Trust||Not yet recruiting|
|London, United Kingdom, E1 1BB|
|Contact: David Propper|
|Principal Investigator: David Propper|
|Principal Investigator:||David Propper||Barts & The London NHS Trust|
|Principal Investigator:||Erkut Borazanci||HonorHealth Research Institute|