Breast Cancer Clinical Trial
— Minnelide 101Official title:
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
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
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) |
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 |
Lead Sponsor | Collaborator |
---|---|
Minneamrita Therapeutics LLC | Translational Drug Development |
United States,
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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