Capecitabine/Tesetaxel Versus Capecitabine/Placebo as Second-line Therapy for Gastric Cancer

Study Overview
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Brief Summary
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This study is being performed to evaluate the efficacy and safety of capecitabine in combination with tesetaxel versus capecitabine in combination with placebo as second-line treatment for patients with gastric cancer.

Official Title
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A Randomized, Double-blind Study of Capecitabine Plus Tesetaxel Versus Capecitabine Plus Placebo as Second-line Therapy in Subjects With Gastric Cancer

Conditions
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Gastric Carcinoma

Intervention / Treatment
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* Drug: Tesetaxel
* Drug: Placebo
* Drug: Capecitabine


Participation Criteria
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Eligibility Criteria
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Key inclusion criteria: Histologically or cytologically confirmed gastric adenocarcinoma, including gastric or gastroesophageal-junction adenocarcinoma (Histologically confirmed adenocarcinoma of the lower esophagus acceptable with radiographic or endoscopic documentation of gastroesophageal-junction or proximal-stomach involvement.) Measurable disease (revised RECIST) based on computed tomography, or nonmeasurable disease ECOG performance status 0 or 1 Treatment with only 1 prior regimen (as first-line therapy) that must have included a fluoropyrimidine and a platinum-containing agent (Prior adjuvant or neo-adjuvant chemotherapy acceptable provided 6 months elapsed between the end of this therapy and the start of first-line therapy.) Disease progression after the start of the 1 prior regimen based on computed tomography Adequate bone marrow, hepatic, and renal function Ability to swallow an oral solid-dosage form of medication Key exclusion criteria: Squamous cell gastric carcinoma Bone-only metastatic disease History or presence of brain metastasis or leptomeningeal disease Operable gastric or gastroesophageal-junction cancer HER2-positive disease if the patient has not previously been treated with an anti-HER2 agent Uncontrolled diarrhea, nausea, or vomiting Known malabsorptive disorder Significant medical disease other than gastric cancer Presence of neuropathy > Grade 1 (NCI Common Toxicity Criteria) Prior treatment (including adjuvant therapy) with a taxane or other tubulin-targeted agent (indibulin, eribulin, etc.) Prior radiation therapy to more than 25% of the bone marrow Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway Pregnancy or lactation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Capecitabine-tesetaxel<br>21-day cycle; tesetaxel 27 mg/m2 orally once on Day 1; capecitabine 1750 mg/m2/day orally in 2 equally divided doses on Days 1-14 | Drug: Tesetaxel<br>* Tesetaxel 27 mg/m2 orally once on Day 1 of each cycle<br>Drug: Capecitabine<br>* Capecitabine 1750 mg/m2/day orally twice daily (in 2 equally divided doses) on Days 1-14 of each cycle<br>* Other names: Xeloda;|
| Active Comparator: Capecitabine-placebo<br>21-day cycle; placebo orally once on Day 1; capecitabine 1750 mg/m2/day orally in 2 equally divided doses on Days 1-14 | Drug: Placebo<br>* Placebo orally once on Day 1 of each cycle<br>Drug: Capecitabine<br>* Capecitabine 1750 mg/m2/day orally twice daily (in 2 equally divided doses) on Days 1-14 of each cycle<br>* Other names: Xeloda;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | When at least 508 events of death have occurred, which is estimated will occur 12 months after the date of randomization of the last patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease control rate | The percentages of patients with complete or partial response of any duration or stable disease lasting at least 6 weeks from the date of randomization (revised RECIST) | Estimated will be assessed 12 months after the date of randomization of the last patient | 
| Progression-free survival | Calculated from the date of randomization to the date when disease progression is first documented or when the patient dies within 60 days of the last lesion assessment | Estimated will be assessed 12 months after the date of randomization of the last patient | 
| Response rate in patients with measurable disease | The percentages of patients with complete or partial response (revised RECIST) | Estimated will be assessed 12 months after the date of randomization of the last patient | 
| Incidence of adverse events | The percentages of patients who experience adverse events by specific adverse event term | Through 30 days after the last dose of study medication |