A Phase II Study of Tesetaxel Administered at a Flat Dose Once Every 21 Days as Second-line Therapy to Subjects With Advanced Gastric Cancer

Inclusion Criteria

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