Description:
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
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
Recruiting
Phase 1
Drug | Synonyms | Arms |
---|---|---|
Minnelide™Capsules | Regimen A (monotherapy) |
Name | Type | Description | Interventions |
---|---|---|---|
Regimen A (monotherapy) | Experimental | 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. |
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Regimen B (combination) | Experimental | 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. |
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Regimen C (monotherapy in Gastric Cancer) | Experimental | 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. |
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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)
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Measure: | Number of Participants With Treatment-Related Adverse Events |
Time Frame: | 24 months |
Safety Issue: | |
Description: | as assessed by CTCAE V4 .03 |
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Minneamrita Therapeutics LLC |
April 21, 2021