Histologically or cytologically confirmed gastric carcinoma, including gastric or gastroesophageal-junction adenocarcinoma MedDRA version: 14.1 Level: LLT Classification code 10017760 Term: Gastric cancer NOS System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: PT Classification code 10017758 Term: Gastric cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Tesetaxel 5
Product Code: DJ-927
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Tesetaxel
Current Sponsor code: DJ-927
Concentration unit: mg milligram(s)
Concentration type: e
Sponsors
Genta Incorporated
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. At least 18 years of age 2. Histologically or cytologically confirmed gastric adenocarcinoma, including gastric or gastroesophageal-junction adenocarcinoma. (Histologically confirmed adenocarcinoma of the lower esophagus is acceptable if there is radiographic or endoscopic documentation of gastroesophageal-junction or proximal-stomach involvement.) 3. Measurable disease (revised RECIST) version 1.1. based on computed tomography, or nonmeasurable disease 4. Eastern Cooperative Oncology Group performance status 0 or 1 5. Treatment with only 1 prior regimen (as first-line therapy) that must have included a fluoropyrimidine and a platinum-containing agent N.B. Prior adjuvant or neo-adjuvant chemotherapy is acceptable provided that 6 months elapsed between the end of the adjuvant or neoadjuvant therapy and the start of first-line therapy. N.B. If disease progression is documented within 2 months after the end of adjuvant or neoadjuvant chemotherapy with a fluoropyrimidine and a platinum-containing agent, that adjuvant or neoadjuvant chemotherapy will be considered first-line therapy. 6. Disease progression after the start of the 1 prior regimen based on computed tomography (or magnetic resonance imaging in the event of allergy to contrast medium) N.B. Residual disease that is documented within 2 months after the end of adjuvant or neoadjuvent chemotherapy with a fluoropyrimidine and a platinum-containing agent will be considered disease progression. 7. Adequate bone marrow, hepatic, and renal function, as evidenced by: a. Absolute neutrophil count (ANC) at least 1500/mm3 b. Platelet count at least 100,000/mm3 c. Hemoglobin >= 10 g/dL without the need for hemotopoietic growth factor or transfusion support d. Aspartate aminotransferase = 1.5 times the upper limit of normal (x ULN) or, in the presence of liver metastasis, = 2.5 x ULN e. Alanine aminotransferase = 1.5 x ULN or, in the presence of liver metastasis, = 2.5 x ULN f. Total bilirubin within the normal range except in the presence of Gilbert's disease. N.B. In subjects with Gilbert's diseae, contact the Genta Medical Monitor prior to enrollment. g. Serum creatinine = 1.5 x ULN or calculated creatinine clearence not less than 50 mL/min based on the Cockcroft-Gault formula. (See appendix B of protocol for further information) 8. At least 3 weeks and recovery from effects of prior major surgery or radiation therapy 9. If previously administered as treatment for gastric cancer, prior to study entry a washout period equivalent to at least 5 half-lives for antibodies and of at least 21 days for chemotherapy (Concurrent use of bisphosphonates is permitted.) 10. Ability to swallow an oral solid-dosage form of medication, including when a feeding tube is present. 11. A negative serum pregnancy test within 7 days prior to randomization in women of childbearing potential (that is, all women except those who are post menopause for > 1 year or who have a history of hysterectomy or surgical sterilization) 12. Agreement to use an effective form of contraception (ie, one that has a failure rate of 1 year or who have a history of hysterectomy or surgical sterilization) and sexually active men. 13. All participating countries except France: Written informed consent and authorization to use and disclose health information. In Fra
Exclusion criteria
Exclusion criteria: 1.Squamous cell gastric carcinoma 2.Bone-only metastatic disease 3. History or presence of brain metastasis or leptomeningeal disease 4. Operable gastric or gastroesophageal-junction cancer 5. HER2-positive disease if the subject has not previously been treated with an anti-HER2 agent 6. Uncontrolled diarrhea, defined as more than 3 loose bowel movements above the subject’s usual number of bowel movements on at least 3 days within the 14 days prior to randomization 7. Nausea or vomiting for at least 3 consecutive days within the 14 days prior to randomization despite the administration of standard antiemetic therapy 8. Known malabsorptive disorder 9. Second cancer (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the subject has been disease-free for 5 or more years) 10. Human immunodeficiency virus infection based on history of positive serology 11. Significant medical disease other than gastric cancer, including but not limited to uncontrolled diabetes mellitus, active angina or heart failure, uncontrolled hypertension, or an active psychiatric condition that would prevent consistent and compliant participation in the study 12. Presence of neuropathy > Grade 1 (National Cancer Institute Common Toxicity Criteria; Version 4.0) 13. Prior treatment (including adjuvant therapy) with a taxane or other tubulin-targeted agent (indibulin, eribulin, etc.) 14. Prior radiation therapy to more than 25% of the bone marrow 15. Need for other anticancer treatment (such as chemotherapy, radiation therapy, or biologic therapy with an approved or investigational agent) while receiving protocol therapy 16. Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway 17. Less than 2 weeks since use of a medication or ingestion of an agent, beverage, or food that is a potent inhibitor or inducer of the CYP3A pathway 18. History of severe or unexpected reaction to fluoropyrimidine therapy. 19. History of hypersensitivity to capecitabine, other fluoropyrimidine agents or any of their ingredients. 20. Known dihydropyrimidine dehydrogenase deficiency 21. Pregnancy or lactation 22.Participation in another clinical trial in which an investigational agent is required to be administered during the treatment phase of study TOG301 23. In France only: Being of full age under legal protection or being deprived of liberty
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy and safety of capecitabine plus tesetaxel (capecitabine-tesetaxel) versus capecitabine plus placebo (capecitabine-placebo) as second-line therapy in subjects with gastric cancer;Secondary Objective: None;Primary end point(s): Overall survival;Timepoint(s) of evaluation of this end point: When at least 508 events (deaths) have occurred which is estimated will occur 12 months after the date of randomization of the last subject | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy Secondary efficacy endpoints include: • the percentages of subjects with disease control (complete or partial response of any duration or stable disease lasting at least 6 weeks from the date of randomization [the disease control rate]). (Complete response, partial response, and stable disease are as defined in the revised Response Evaluation Criteria in Solid Tumors [RECIST].) Version 1.1 • progression-free survival • point estimates of overall survival every 6 months for up to 24 months from the date of randomization For exploratory purposes, the following will be calculated only in subjects with measurable disease: • the percentage of subjects with response (complete or partial response [the response rate]) (RECIST) version 1.1 • the percentage of subjects with durable response (complete or partial response at least 6 months in duration [the durable response rate]) Safety • adverse events • changes in clinical laboratory tests ;Timepoint(s) of evaluation of this end point: At the time of the analysis of the primary end point | — |
Countries
China, France, Germany, Italy, Korea, Republic of, Spain, Taiwan, United States
Contacts
Public ContactGenta Medical Information
Genta Incorporated
Outcome results
None listed