None listed
Conditions
Interventions
Drug : Minnelide™ Capsules 1.25 mg will be administered orally once daily on Days 1 to 5, 8 to 12 and 15 to 19 in combination with paclitaxel (80 mg/m2) which will be administered Intravenous(IV) on D
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with histologically or cytologically confirmed locally advanced unresectable, recurrent or metastatic gastric cancer. 2. Tumor progression after receiving at least 1 prior regimen of systemic therapy for locally advanced unresectable, recurrent or metastatic gastric cancer including chemotherapy, immunotherapy, targeted therapy, radiotherapy, or where there is no approved therapy as per the independent clinical judgement of the Investigator. 3. Has not been exposed to taxane-based chemotherapy. 4. Patients must have an evaluable lesion per Response Evaluation Criteria in Solid Tumors(RECIST) V1.1. 5. Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1. 6. Patients with a life expectancy = 3 months are able and willing to offer written informed consent to participate in the study. 7. Female or male age = 19 years. 8. Signed, written Institutional Review Board (IRB)-approved informed consent. 9. Adequate organ function, as indicated by the following laboratory values: -Acceptable liver function: Bilirubin = 1.5 times upper limit of normal. Aspartate aminotransferase (AST) (SGOT), aspartate aminotransferase (ALT) (SGPT) and alkaline phosphatase = 2.5 times upper limit of normal (ULN) (if liver metastases are present, then = 5 × Upper limits of normal(ULN) is allowed). Albumin = 3.0 g/dL. -Acceptable renal function: Serum creatinine within normal limits, OR calculated creatinine clearance = 45 mL/min/1.73 m2 for patients with elevated creatinine levels using site/institutional practice for the calculation. -Acceptable hematologic status: Absolute neutrophil count = 1000 cells/mm3. Platelet count = 100000 (plt/ mm3). Hemoglobin = 9 g/dL. -Acceptable coagulation status: International normalized ratio (INR) = 1.5 times institutional Upper limits of normal(ULN). (The International normalized ratio(INR) applies only to patients who do not receive therapeutic anticoagulation). Prothrombin time (PT) = 1.5 times institutional Upper limits of normal(ULN). Activated partial thromboplastin time (APTT) = 1.5 times institutional Upper limits of normal(ULN). 10. Females must not be pregnant or lactating, and must use acceptable, highly effective double contraception from Screening until 6 months after the last dose of Investigational product(IP). Effective forms of contraception are defined as follows. (a. Simultaneous use of hormonal contraceptives and must agree to use the same hormonal contraceptive throughout the study, and condom for the male partner. b. Simultaneous use of intrauterine device(IUD) and condom for the male partner. c. Simultaneous use of diaphragm or cervical cap and male condom for the male partner. d. Sterile male partner (> 30 days vasectomized prior to first Investigational product (IP) administration). e. True abstinence, defined as no sexual intercourse (heterosexual couples). Periodic abstinence and withdrawal are not acceptable methods.) Females with same-sex partners (abstinence from penile-vaginal intercourse) or who are abstinent from heterosexual intercourse are not required to use contraception when this is their preferred and usual lifestyle. Women of childbearing potential (WOCBP) must have a negative pregnancy test at Screening and Day 1 and be willing to have additional pregnancy tests as required throughout the study. Women not of childbearing potential must be postmenopausal for = 12 months (postmenopausal status is to be confirmed through testing of follicle-stimulating hormone [
Exclusion criteria
Exclusion criteria: 1. Patients who have not recovered from Adverse Event(AE)s due to prior anti-cancer therapy (i.e.,to Grade = 1 or to baseline, as evaluated by National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0) with the exception of alopecia and = Grade 2 neutropenia. 2. Patients with other active malignancies within 5 years or at the same time. Localized tumors that have been cured such as basal cell carcinoma, squamous-cell skin cancer, superficial bladder carcinoma, prostate carcinoma in situ, cervical carcinoma in situ, and breast cancer in situ are acceptable. 3. Active or untreated central nervous system metastases and/or carcinomatous meningitis should be excluded. However, patients with previously treated brain metastases may participate if they are clinically stable and are on a stable dose of steroids/anti-convulsant for at least 4 weeks without dose change and have no evidence of new or enlarging brain metastases prior to dosing with study medication. 4. Current or prior use of immunosuppressive medication within 14 days before the first dose of Investigational product (IP) (exception: systemic corticosteroids at physiologic doses not exceeding 10 mg/day of prednisone or equivalent are allowed, as well as steroids as premedication for hypersensitivity reactions [e.g., Computed tomography(CT)-scan premedication]; topical, inhaled, nasal, and ophthalmic steroids are also allowed). 5. Patients who are preparing for or have received an organ or bone marrow transplant. 6. Have acute myocardial infarction, unstable angina or clinically significant evidence of ischemia on Electrocardiogram(ECG), stroke, or transient ischemic attack within 6 months prior to the first dose of Investigational product (IP); patients who have congestive heart failure (New York Heart Association(NYHA) Classification Class III or IV); or have unstable arrhythmia. 7. Baseline Q-T corrected interval (QTc) exceeding 470 msec (using the Bazett’s formula) and/or patients receiving class 1A or class III antiarrhythmic agents. If a single value of Bazett formula-corrected QT interval (QTcB) is > 470 ms but not clinically significant as per the Investigator, triplicate Electrocardiogram(ECG)s should be performed and if the average Bazett formula-corrected QT interval (QTcB) = 470 ms, then the patient can be included in the study. 8. Active infection that requires systemic anti-infective therapy occurs within 14 days prior to first dose of Investigational product (IP); The exception is prophylactic antibiotic treatment (such as prevention of urinary tract infections or chronic obstructive pulmonary disease). 9. Pregnant or nursing women. 10. Patients who received anti-tumor therapy (except for mitomycin, nitrosourea, and fluorouracil oral drugs) within 4 weeks, or within 5-half-lives (whichever is longer) prior to the first dose of Investigational product (IP), including but not limited to chemotherapy, targeted therapy or immunotherapy. NOTE: The last dose of mitomycin and nitrosourea should be at least 6 weeks before Investigational product (IP) initiation; the last dose of oral fluorouracil should be at least 2 weeks before Investigational product (IP) initiation. 11. Undergone a major surgery or a radiotherapy (for the whole body or a target lesion) within 28 days prior to the Investigational product (IP), or have undergone a local palliative radiotherapy (or for non-target lesion) within 14 days prior to the first dose of In
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events ;Laboratory evaluations data (including hematology, biochemistry, coagulation, and urinalysis) ;Vital signs (blood pressure, pulse rate, respiratory rate, and body temperature) data;12-Lead Electrocardiogram (ECG)s data | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete response(CR) Partial response(PR), Stable disease(SD), and disease progression will be evaluated, and Objective response rate (ORR), Disease control rate(DCR), duration of response(DOR) , and PFS(progression-free survival) will be determined according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Objective measurements of tumor size will be recorded from computed tomography (CT) scan or other measures.;Pharmacodynamic Analyses(blood samples of Cancer Antigen 72-4(CA72-4), Cancer Antigen(CA 19-9), Carcinoembryonic Antigen(CEA), and circulating deoxyribonucleic acid (DNA) as applicable, and tumor tissues of programmed Death-Ligand 1(PD-L1) and Human Epidermal Growth Factor Receptor 2(HER2) expressions) | — |
Countries
Korea, Republic of
Contacts
Public ContactJeeyun Lee
Samsung Medical Center
Outcome results
None listed