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Anti-tumor antibiotic

Minnelide for Advanced Cancer (Minnelide 101 Trial)

Phase 1
Recruiting
Research Sponsored by Minneamrita Therapeutics LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Karnofsky performance ≥ 70%
A negative pregnancy test (if female)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Minnelide 101 Trial Summary

This trial is testing a new drug, Minnelide, to see if it is safe and effective for treating patients with advanced solid tumors.

Who is the study for?
Adults with advanced solid tumors, including specific types for different regimens: any solid tumor (A), breast/pancreas (B), or gastric cancer (C). Must have progressed after standard treatment or lack approved therapy options. Requires measurable metastatic tumor(s), good performance status, life expectancy over 3 months, and proper organ function. Excludes those with severe heart issues, recent serious infections, pregnant/nursing women, and those on certain medications.Check my eligibility
What is being tested?
Minnelide™ Capsules are being tested alone or combined with protein-bound paclitaxel in patients with various advanced cancers. The study involves taking the capsules daily for three weeks followed by a week off to evaluate safety, how the body processes the drug, and its effects on tumors.See study design
What are the potential side effects?
While not specified here, common side effects of chemotherapy drugs like Minnelide™ may include nausea, vomiting, diarrhea fatigue hair loss anemia infection risk liver kidney problems blood clotting disorders nerve muscle pain.

Minnelide 101 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am able to care for myself but may not be able to do active work.
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I am not pregnant.
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My kidney function is normal or nearly normal.
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My cancer has worsened after standard treatment or there's no approved treatment for it.
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I am 18 years old or older.

Minnelide 101 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Anti-tumor activity
Number of Participants With Treatment-Related Adverse Events

Minnelide 101 Trial Design

3Treatment groups
Experimental Treatment
Group I: Regimen C (monotherapy in Gastric Cancer)Experimental Treatment1 Intervention
Minnelide™ Capsules will be given as a single agent orally once daily x 21 days followed by a 7-day rest period. One cycle will equal 28 days. Minnelide™ Capsules should be given with the patient in a fasting state.
Group II: Regimen B (combination)Experimental Treatment1 Intervention
MinnelideTM Capsules will be given orally once daily x 21 days in combination with protein-bound paclitaxel given intravenously on days 1, 8 and 15 in patients with pancreas and breast cancer. One cycle will equal 28 days. MinnelideTM Capsules should be given with the patient in a fasting state.
Group III: Regimen A (monotherapy)Experimental Treatment1 Intervention
Minnelide™ Capsules will be given as a single agent orally once daily x 21 days followed by a 7-day off schedule. One cycle will equal 28 days. MinnelideTM Capsules should be given with the patient in a fasting state.

Find a Location

Who is running the clinical trial?

Minneamrita Therapeutics LLCLead Sponsor
6 Previous Clinical Trials
163 Total Patients Enrolled
Translational Drug DevelopmentOTHER
18 Previous Clinical Trials
946 Total Patients Enrolled
Jordan Jacobs, MBAStudy DirectorTranslational Drug Development

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Phase 1, Multi-Center, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Minnelide™ Capsules Given Alone or in Combination With Protein-Bound Paclitaxel in Patients With Advanced Solid Tumors
2017. "A Phase 1, Multi-Center, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Minnelide™ Capsules Given Alone or in Combination With Protein-Bound Paclitaxel in Patients With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03129139.
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