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

Genta Incorporated

Status and phase

Unknown

Phase 2

Conditions

Adenocarcinoma of the Stomach

Adenocarcinoma of Esophagogastric Junction

Treatments

Drug: Tesetaxel

Study type

Interventional

Funder types

Industry

Identifiers

NCT01095120

TOG201

Details and patient eligibility

About

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.

Enrollment

27 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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