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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03129139
Other study ID # Minnelide 101
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date October 10, 2017
Est. completion date December 1, 2024

Study information

Verified date October 2023
Source Minneamrita Therapeutics LLC
Contact Jordan Jacobs, MBA
Phone 602-358-8376
Email jjacobs@td2inc.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A Phase I, Multicenter, Open-label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of Minnelide™Capsules given daily for 21 days followed by 7 days off schedule in patients with Advanced Solid Tumors


Recruitment information / eligibility

Status Recruiting
Enrollment 66
Est. completion date December 1, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Intervention

Drug:
Minnelide™Capsules
Minnelide™ is a water soluble disodium salt variant of triptolide an heat shock protein (HSP) inhibitor.

Locations

Country Name City State
United States University of Alabama at Birmingham Birmingham Alabama
United States Mayo Clinic Jacksonville Florida
United States Cedars-Sinai Medical Center Los Angeles California
United States Mayo Clinic Arizona Phoenix Arizona
United States Mayo Clinic Rochester Minnesota
United States HonorHealth Research Institute Scottsdale Arizona
United States Wake Forest Baptist Health Winston-Salem North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Minneamrita Therapeutics LLC Translational Drug Development

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Treatment-Related Adverse Events as assessed by CTCAE V4 .03 24 months
Primary Anti-tumor activity RECIST 1.1 24 months
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