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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)

Must not have

Baseline QTc exceeding 470 msec (using the Bazett's formula) and/or patients receiving class 1A or class III antiarrhythmic agents

Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

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

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My heart's electrical activity is normal and I'm not on specific heart rhythm medications.

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I do not have any serious infections that need treatment.

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I have severe heart issues, recent heart attack, or unstable heart rhythm.

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I am not taking any medications that are not allowed in the study.

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I have been diagnosed with HIV, hepatitis B, or hepatitis C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

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

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

Primary study objectives

Anti-tumor activity

Number of Participants With Treatment-Related Adverse Events

Awards & Highlights

No Placebo-Only Group

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

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.

0 / 10Eligibility criteria met