What side effects are associated with this type of intervention?

Common treatments for pancreatic carcinoma, such as gemcitabine and nab-paclitaxel, are associated with side effects including neutropenia, fatigue, neuropathy, and diarrhea. Fluoropyrimidines like capecitabine can cause hand-foot syndrome, diarrhea, and mucositis. Minnelide, currently under investigation, may have side effects similar to other chemotherapeutic agents, but specific data on its side effects are not yet well-documented.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic carcinoma, particularly for advanced stages. Gemcitabine, often used in combination with other agents like nab-paclitaxel, has been a cornerstone of treatment. The combination of gemcitabine and nab-paclitaxel (gem/nab) has shown efficacy in clinical trials and is commonly used. Additionally, the multiagent regimen FOLFIRINOX, which includes oxaliplatin, irinotecan, leucovorin, and fluorouracil, is another FDA-approved treatment for pancreatic cancer, particularly for patients who can tolerate its intensity. These treatments aim to improve survival and manage symptoms in patients with advanced pancreatic cancer.

What other types of research exist?

Promising novel alternatives to Minnelide for pancreatic carcinoma patients include: <ol> <li>Immunotherapy agents such as pembrolizumab (Keytruda) and nivolumab (Opdivo), which target PD-1/PD-L1 pathways.</li> <li></li> </ol> Targeted therapies like olaparib (Lynparza) for patients with BRCA mutations. 3. Combination therapies involving chemotherapy agents like FOLFIRINOX (a combination of folinic acid, fluorouracil, irinotecan, and oxaliplatin) or gemcitabine with nab-paclitaxel (Abraxane). 4. Experimental treatments in clinical trials, such as CAR-T cell therapy and novel kinase inhibitors. Patients should discuss these options with their oncologist to determine the best course of action based on their specific medical condition.

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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.

Must not have

Has known uncontrolled or poorly controlled human immunodeficiency virus (HIV) infection. HIV is considered uncontrolled or poorly controlled if an HIV-infected individual is not taking highly active anti-retroviral therapy or has a detectable viral load within the previous 6 months.

Has an active infection requiring systemic therapy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up start of treatment to 30 days after last treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing Minnelide, a pill taken by mouth, to treat a rare and aggressive type of pancreatic cancer called ASCP. The trial targets adults whose cancer did not respond to previous treatments. Minnelide works by blocking a protein that helps the cancer grow, potentially controlling the disease.

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have HIV that is not well-managed or under control.

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I am currently being treated for an infection.

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I cannot take pills due to vomiting or a condition that affects my eating.

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I have cancer that has spread to my brain or spinal cord.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and start of treatment to 30 days after last treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

disease control rate

Secondary study objectives

Overall Survival (OS)

progression free survival (PFS)

safety and tolerability of Minnelide

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for pancreatic carcinoma, such as Minnelide, gemcitabine, and FOLFIRINOX, work by disrupting critical cellular processes in cancer cells. Minnelide depletes reactive stromal fibroblasts and disrupts oncogenic signaling, leading to tumor regression. Gemcitabine and FOLFIRINOX interfere with DNA replication and cell division, inhibiting tumor growth. Capecitabine is selectively activated in tumor tissues, enhancing its efficacy while minimizing side effects. These mechanisms are important for patients as they target both the tumor cells and the supportive stromal environment, potentially improving treatment outcomes.

Inactivation of Cancer-Associated-Fibroblasts Disrupts Oncogenic Signaling in Pancreatic Cancer Cells and Promotes Its Regression.A Novel Immunocompetent Mouse Model of Pancreatic Cancer with Robust Stroma: a Valuable Tool for Preclinical Evaluation of New Therapies.Pristimerin, a quinonemethide triterpenoid, induces apoptosis in pancreatic cancer cells through the inhibition of pro-survival Akt/NF-κB/mTOR signaling proteins and anti-apoptotic Bcl-2.