Tesetaxel Plus Capecitabine and Cisplatin in Advanced Gastric Cancer

Study Overview
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Brief Summary
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Cisplatin, an intravenously administered platinum agent, in combination with an intravenously administered taxane and capecitabine has been shown to improve time to disease progression and overall survival in previously untreated patients with gastric cancer. This study is being performed to evaluate an orally administered taxane (tesetaxel) in combination with cisplatin and capecitabine in previously untreated patients with gastric cancer.

Official Title
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A Phase I-II Study of Tesetaxel Plus Capecitabine and Cisplatin in Subjects With Advanced Gastric Cancer

Conditions
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Gastric Carcinoma

Intervention / Treatment
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* Drug: Tesetaxel-capecitabine-cisplatin


Participation Criteria
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Eligibility Criteria
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Primary Inclusion Criteria: At least 20 years of age Histologically or cytologically confirmed gastric carcinoma, including gastric or gastroesophageal-junction adenocarcinoma. Measurable disease (revised RECIST) based on computed tomography, or nonmeasurable disease Previously untreated, unresectable advanced (M0) or unresectable metastatic (M1) disease except for prior adjuvant (or neo-adjuvant) chemotherapy. ECOG performance status 0 or 1 At least 4 weeks and recovery from effects of prior major surgery Adequate bone marrow, hepatic, and renal function Primary Exclusion Criteria: Operable gastric or gastroesophageal-junction cancer Known brain metastasis Second cancer Previous adjuvant or neo-adjuvant chemotherapy with capecitabine and cisplatin in combination. (Previous adjuvant or neo-adjuvant monotherapy with capecitabine or S-1 or therapy with S-1 and cisplatin in combination or 5-FU and cisplatin in combination is allowed.) Uncontrolled diarrhea Nausea or vomiting for at least 3 consecutive days within the 14 days prior to registration despite the administration of standard antiemetic therapy Symptomatic peripheral neuropathy ≥ Grade 2 Malabsorption syndrome or other disease that significantly affects gastrointestinal function Other uncontrolled systemic illness

Ages Eligible for Study
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Minimum Age: 20 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tesetaxel-capecitabine-cisplatin<br> | Drug: Tesetaxel-capecitabine-cisplatin<br>* Phase 1: Tesetaxel orally on Day 1 of each cycle at dose of 18, 21, 24, or 27 mg/m2. If no dose-limiting toxicity, at least 3 subjects will be treated at each dose level until the maximum tolerated dose or the maximum dose of 27 mg/m2 is reached. At each tesetaxel dose level, capecitabine orally at a dose of 2000 mg/m2/day (administered in 2 equally divided doses) on Day 1-Day 14 and cisplatin intravenously at a dose of 60 mg/m2 on Day 1. Phase 2: Tesetaxel orally on Day 1 of each cycle at dose determined in Phase 1. Capecitabine orally at a dose of 2000 mg/m2/day (administered in 2 equally divided doses) on Day 1-Day 14 and cisplatin intravenously at a dose of 60 mg/m2 on Day 1.<br>* Other names: Platinol-AQ;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival rate (in Phase 2 portion of study) |  | 6 months from the date of first dose of study medication | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recommended dose of tesetaxel for Phase 2 (in Phase 1 portion of study) | The dose of tesetaxel in mg/m2 will be determined for Phase 2 based on the occurrence of dose-limiting toxicities in Phase 1. | Up to 21 days after first dose of study medication | 
| Response rate, as defined in revised RECIST (in Phase 2 portion of study) |  | Up to 12 months following the date of first dose of study medication | 
| Duration of response (in Phase 2 portion of study) |  | Up to 12 months following the date of first dose of study medication | 
| Rate of responses at least 3 months in duration (in Phase 2 portion of study) |  | Up to 12 months following the date of first dose of study medication | 
| Disease control rate, which is defined as the percentage of patients with a response of any duration or stable disease at least 6 weeks in duration (in Phase 2 portion of study) |  | Up to 12 months following the date of first dose of study medication | 
| Durable response rate, which is defined as the percentage of patients with a response at least 6 months in duration (in Phase 2 portion of study) |  | Up to 12 months following the date of first dose of study medication | 
| Progression-free survival (in Phase 2 portion of study) |  | Up to 12 months following the date of first dose of study medication | 
| Overall survival (in Phase 2 portion of study) |  | Up to 12 months following the date of first dose of study medication | 
| Percentage of patients with adverse events (in Phase 1 and Phase 2 portions) |  | Up to 30 days after the last dose of study medication | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric cancer, First-line therapy, Tesetaxel, Taxane, Capecitabine, Oral fluoropyrimidine, Cisplatin, Platinum