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
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
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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)
Clareo Health | 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
