Testing Minnelide™ Capsules for Advanced Solid Tumors

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

This study is testing if daily doses of Minnelide™ Capsules can help people with advanced solid tumors feel better and manage their cancer.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Minneamrita Therapeutics LLC (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 7 sites (Birmingham, Alabama and 6 other locations)
• Trial ID: NCT03129139 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of Minnelide™ Capsules, administered daily for 21 days followed by a 7-day break, in patients with advanced solid tumors. It is a Phase 1, multi-center, open-label, dose-escalation study that includes patients with various types of advanced cancers, including breast, pancreatic, and gastric cancers. The study aims to assess pharmacokinetics and pharmacodynamics, as well as the potential benefits of combining Minnelide™ with protein-bound paclitaxel. Participants will be closely monitored for tumor progression and overall health.

Who should consider this trial

Good fit: Ideal candidates include adults with histologically confirmed advanced solid tumors who have experienced tumor progression after standard chemotherapy.

Not a fit: Patients with early-stage cancer or those who have not yet undergone standard treatment options may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors who have limited therapeutic alternatives.

How similar studies have performed: Other studies have shown promise with similar approaches, but this specific combination is being explored for the first time.

Eligibility criteria

Inclusion:

* Patients with histologically confirmed advanced solid tumors (regimen A), breast or pancreas (regimen B), or gastric cancer (regimen C)
* Tumor progression after receiving standard/approved chemotherapy or where there is no approved therapy
* Prior treatment with protein-bound paclitaxel allowed if it has been six months since received or progressed on protein-bound paclitaxel and plan to continue to receive protein-bound paclitaxel with MinnelideTM Capsules
* One or more metastatic tumors measurable per RECIST v1.1 Criteria
* Karnofsky performance ≥ 70%
* Life expectancy of at least 3 months
* Age ≥ 18 years
* Signed, written IRB-approved informed consent
* A negative pregnancy test (if female)
* Acceptable liver function:

  * Bilirubin ≤ 1.5 times upper limit of normal
  * AST (SGOT), ALT (SGPT) and Alkaline phosphatase ≤ 2.5 times upper limit of normal (if liver metastases are present, then ≤ 5 x ULN is allowed)
  * Albumin ≥ 3.0 g/dL
* Acceptable renal function:

  o Serum creatinine within normal limits, OR calculated creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
* Acceptable hematologic status:

  * Granulocyte ≥ 1500 cells/mm3
  * Platelet count ≥ 100,000 (plt/mm3)
  * Hemoglobin ≥ 9 g/dL
* Urinalysis:

  o No clinically significant abnormalities
* Acceptable coagulation status:

  * PT ≤ 1.5 times institutional ULN
  * PTT ≤ 1.5 times institutional ULN
* For men and women of child-producing potential, the use of effective contraceptive methods during the study

Exclusion Criteria:

* New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG
* 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
* Pregnant or nursing women. NOTE: Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
* Treatment with radiation therapy, surgery, chemotherapy, or investigational therapy within one month prior to study entry (6 weeks for nitrosoureas or Mitomycin C).
* Unwillingness or inability to comply with procedures required in this protocol
* Known infection with HIV, hepatitis B, or hepatitis C
* Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
* Patients who are currently receiving any other investigational agent
* Patients who are on a prohibited medication (section 4.4.2).
* Patients with biliary obstruction and/or biliary stent (Regimen B only)

Where this trial is running

Birmingham, Alabama and 6 other locations

• University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
• Mayo Clinic Arizona — Phoenix, Arizona, United States (Withdrawn)
• HonorHealth Research Institute — Scottsdale, Arizona, United States (Recruiting)
• Cedars-Sinai Medical Center — Los Angeles, California, United States (Recruiting)
• Mayo Clinic — Jacksonville, Florida, United States (Terminated)
• Mayo Clinic — Rochester, Minnesota, United States (Terminated)
• Wake Forest Baptist Health — Winston-Salem, North Carolina, United States (Recruiting)

Study contacts

• Study coordinator: Jordan Jacobs, MBA

Conditions Advanced Cancer; Gastric Cancer; Breast Cancer; Pancreatic Cancer; Prostate Cancer Metastatic; Colo-rectal Cancer; Solid Tumor; Solid Carcinoma