Clinical Trials

Inclusion Criteria:

• Patients with histologically confirmed advanced solid tumors (regimen A) or breast or pancreas (regimen B).
• 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:
  • Serum creatinine within normal limits, OR calculated creatinine clearance 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal.
• Acceptable hematologic status:
  • Granulocyte ≥ 1500 cells/mm^3;
  • Platelet count ≥ 100,000 (plt/mm^3);
  • Hemoglobin ≥ 9 g/dL.
• Urinalysis:
  • 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 antiarrythmic 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.
• Patients with biliary obstruction and/or biliary stent (Regimen B only).