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
• 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