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Superenhancer Inhibitor
Minnelide for Pancreatic Cancer
Phase 2
Recruiting
Led By Christine C Alewine, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Progressive disease as evidenced by increasing tumor size on radiologic assessment, increasing serum tumor marker (on last 2 measurements taken at least 1 week apart), increasing ascites, and/or worsening tumor-related symptoms such as weight loss, pain, GI upset.
Participants with metastatic, recurrent or locally advanced unresectable disease and progression or intolerance to at least 1 prior systemic treatment regimen in the advanced disease setting.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up start of treatment to 30 days after last treatment
Awards & highlights
Study Summary
This trial is testing if Minnelide is an effective treatment for ASCP. Eligible adults will take the drug for up to 12 cycles.
Who is the study for?
Adults over 18 with advanced refractory adenosquamous carcinoma of the pancreas (ASCP) that didn't respond to prior treatments. Participants must have a certain level of physical ability, adequate organ function, and measurable disease. They should not be pregnant or breastfeeding and must agree to use contraception during the trial and for some time after.Check my eligibility
What is being tested?
The trial is testing Minnelide's effectiveness against ASCP. Patients will take Minnelide orally for 21 days in each 28-day cycle, up to 12 cycles, documenting their intake in a diary. The study includes regular visits for health checks and may involve optional tumor biopsies.See study design
What are the potential side effects?
Specific side effects are not listed but could include typical reactions related to cancer drugs such as nausea, fatigue, digestive issues, potential heart problems (due to ECG tests), and risks associated with taking oral medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is getting worse, shown by tests or new/worsening symptoms.
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My cancer has spread, can't be surgically removed, and didn't respond well to at least one treatment.
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My cancer has a significant squamous component, confirmed by a pathology lab.
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I can do most of my daily activities without help.
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I am older than 18 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ start of treatment to 30 days after last treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~start of treatment to 30 days after last treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
disease control rate
Secondary outcome measures
Overall Survival (OS)
progression free survival (PFS)
safety and tolerability of Minnelide
Trial Design
1Treatment groups
Experimental Treatment
Group I: 1/MinnelideExperimental Treatment1 Intervention
Minnelide 2mg Days 1-21 of 28 day cycle (x12)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Minnelide
2017
Completed Phase 2
~20
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,664 Previous Clinical Trials
40,925,951 Total Patients Enrolled
Christine C Alewine, M.D.Principal InvestigatorNational Cancer Institute (NCI)
3 Previous Clinical Trials
79 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had cancer treatment in the last 2 weeks.My cancer is getting worse, shown by tests or new/worsening symptoms.I need to take ondansetron or another medication that is not allowed in this trial.I have another cancer besides the one being studied, but it's not getting worse or needing treatment.I have HIV that is not well-managed or under control.My organs and bone marrow are functioning well.My cancer has spread, can't be surgically removed, and didn't respond well to at least one treatment.My cancer has a significant squamous component, confirmed by a pathology lab.I agree to use birth control during and after the study as required.I have recovered from recent surgery or minor procedures before starting treatment.I am currently being treated for an infection.I have active hepatitis B or C, or I am currently being treated for it.I cannot take pills due to vomiting or a condition that affects my eating.I have not received a live vaccine in the last 30 days.I can do most of my daily activities without help.I am older than 18 years.Your disease can be measured using specific criteria called RECIST 1.1.I have cancer that has spread to my brain or spinal cord.
Research Study Groups:
This trial has the following groups:- Group 1: 1/Minnelide
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Minnelide received regulatory clearance from the FDA?
"The safety of Minnelide is assessed as a 2, given that no clinical data supports efficacy yet but some evidence confirms its security."
Answered by AI
Are recruitments for this clinical trial still underway?
"As of this moment, clinicaltrials.gov affirms that recruitment for the trial is still ongoing - having been posted on March 7th 2022 and last amended October 29th 2022."
Answered by AI
What is the capacity of this research project?
"Affirmative, according to clinicaltrials.gov, this experiment is currently enrolling patients. It was initially posted on March 7th 2022 and the latest edit occurred on October 29th of the same year. 55 participants are being recruited from a single facility for this trial."
Answered by AI
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