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

• Status: Unknown status
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Tesetaxel is an orally administered chemotherapy agent of the taxane class. This study is being undertaken to evaluate the efficacy and safety of tesetaxel administered as second-line therapy to patients with advanced gastric cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genta Incorporated

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