None listed
Conditions
Interventions
Drug : Regimen A (monotherapy)
• 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 shou
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients with histologically confirmed advanced gastric cancer • Tumor progression after receiving standard/approved chemotherapy or where there is no approved therapy • One or more metastatic tumors measurable per RECIST v1.1 Criteria • Karnofsky performance = 70% • Life expectancy of at least 3 months • Age ³ 19 years • Signed, written IRB-approved informed consent • A negative pregnancy test (if female) • Acceptable liver function: o Bilirubin £ 1.5 times upper limit of normal o 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) o Albumin = 3.0 g/dL • Acceptable renal function: o Serum creatinine within normal limits, OR calculated creatinine clearance ³ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal. • Acceptable hematologic status: o Granulocyte ? Monotherapy: ³ 1,500 cells/mm3 ? Combination therapy with paclitaxel: ³ 2,000 cells/mm3 o Platelet count ³ 100,000 (plt/mm3) o Hemoglobin ³ 9 g/dL • Urinalysis: o No clinically significant abnormalities • Acceptable coagulation status: o PT = 1.5 times institutional ULN o PTT = 1.5 times institutional ULN • Women of child- bearing potential and men must agree to use adequate contraception For men and women of child-producing potential, the use of effective contraceptive methods during the study and until 90 days after the last dose of IP for men or until 6 months after the last dose of IP for women or 6 months after the last dose of IP with paclitaxel for both men and women.
Exclusion criteria
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: For men and women of child-producing potential, the use of effective contraceptive methods during the study and until 90 days after the last dose of IP for men or untill 6 months after the last dose of IP for women or 6 months after the last dose of IP with paclitaxel for both men and women. 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 (local therapy, nontarget lesion, 2 weeks), major surgery, chemotherapy, biological agents or investigational therapy within 3 weeks prior to study treatment. • 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 4.3.2). • Patients with biliary obstruction and/or biliary stent (Regimen B only) • Patients with a history of severe hypersensitivity reactions to products containing Cremophor® EL (eg, cyclosporin for injection concentrate and teniposide for injection concentrate). • Patient with baseline ANC<1500/mm3
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of Minnelide™ Capsules when given alone or in combination with paclitaxel. ;To establish the dose of Minnelide™ Capsules recommended for future phase II protocol when given alone or in combination with paclitaxel. | — |
Secondary
| Measure | Time frame |
|---|---|
| Biomarkers as applicable for gastric cancer, any tumor marker appropriate to the given cancer or that is known to be elevated in a given patient will be evaluated according the Investigator’s discretion, prior to every Cycle.;Serum HSP70 levels; PET Scans ;Evaluation of CT scans using Choi criteria | — |
Countries
Korea, Republic of
Contacts
Public ContactJeeYun Lee
Samsung Medical Center
Outcome results
None listed