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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Adenocarcinoma of the Stomach, Adenocarcinoma of Esophagogastric Junction

Intervention / Treatment
-----------------
* Drug: Tesetaxel


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tesetaxel|For subjects in Cohort A, a flat dose of 40 mg will be administered in Cycle 1; the dose will be adjusted based on body weight. In subsequent cycles, depending on tolerability, the Cycle 1 flat dose may be increased by 5 mg in Cycle 2, and the Cycle 2 flat dose may again be increased by 5 mg in Cycle 3. For subjects in Cohort B, a flat dose of 50 mg will be administered in Cycle 1; the dose will be adjusted based on body weight. In subsequent cycles, depending on tolerability, the dose may be increased by 10 mg in Cycle 2. For subjects in Cohort C, a dose of 27 mg/m2 will be administered in Cycle 1. In subsequent cycles, depending on tolerability, the dose will be increased to 35 mg/m2 in Cycle 2.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate (Response Evaluation Criteria In Solid Tumors (RECIST)) |  | 12 months from date of first dose of study medication | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  | 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) |  | 12 months from date of first dose of study medication | 
| Duration of response |  | 12 months from date of first dose of study medication | 
| Adverse events |  | Through 30 days post last dose of study medication |