This trial is active, not recruiting.

Conditions adenocarcinoma of the stomach, adenocarcinoma of esophagogastric junction
Treatment tesetaxel
Phase phase 2
Sponsor Genta Incorporated
Start date March 2010
End date September 2012
Trial size 27 participants
Trial identifier NCT01095120, TOG201


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Response rate (Response Evaluation Criteria In Solid Tumors (RECIST))
time frame: 12 months from date of first dose of study medication

Secondary Outcomes

Disease control rate (ie, the percentage of patients with a confirmed complete or partial response [of any duration] or stable disease at least 6 weeks in duration)
time frame: 12 months from date of first dose of study medication
Durable response rate (ie, the proportion of patients with a confirmed complete or partial response at least 6 months in duration)
time frame: 12 months from date of first dose of study medication
Duration of response
time frame: 12 months from date of first dose of study medication
Adverse events
time frame: Through 30 days post last dose of study medication

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in March 2012.
Information provided to ClinicalTrials.gov by Genta Incorporated.