Tesetaxel as Second-line Therapy for Patients With Advanced Gastric Cancer

Primary inclusion criteria:

• Confirmed diagnosis of adenocarcinoma of the stomach or esophagogastric junction
• Measurable disease (revised RECIST; Version 1.1) based on computed tomography
• Eastern Cooperative Oncology Group performance status 0 or 1
• Treatment with only 1 prior regimen (as first-line therapy) and that regimen included a fluoropyrimidine and/or a platinum analogue
• Documented disease progression within 4 months of the last dose of the 1 prior regimen
• Adequate bone marrow, hepatic, and renal function, as defined in the protocol
• At least 4 weeks and recovery from effects of prior surgery or other therapy, including immunotherapy, radiation therapy, or cytokine, biologic or vaccine therapy, with an approved or investigational agent
• Ability to swallow an oral solid-dosage form of medication

Primary exclusion criteria:

• Nonmeasurable disease only (revised RECIST; Version 1.1)
• History or presence of brain metastasis or leptomeningeal disease
• Operable gastric cancer or operable cancer of the esophagogastric junction
• Uncontrolled diarrhea, defined as more than 3 loose bowel movements above the patient's usual number of bowel movements on at least 2 days within the 14 days prior to enrollment
• Uncontrolled nausea or vomiting within the 14 days prior to enrollment despite the administration of standard antiemetic therapy
• Known malabsorptive disorder
• Significant medical disease other than cancer, as defined in the protocol
• Presence of neuropathy > Grade 1 (National Cancer Institute Common Toxicity Criteria [NCI CTC]; Version 4.0)
• Prior treatment with a taxane or other tubulin-targeted agent (eg, indibulin) other than a vinca alkaloid
• Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity