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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
63
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.
Yonsei Cancer Center, Yonsei University College of Medicine
Seoul, South Korea
RECRUITINGProgression-free survival rate (in Phase 2 portion of study)
Time frame: 6 months from the date of first dose of study medication
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.
Time frame: Up to 21 days after first dose of study medication
Response rate, as defined in revised RECIST (in Phase 2 portion of study)
Time frame: Up to 12 months following the date of first dose of study medication
Duration of response (in Phase 2 portion of study)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Up to 12 months following the date of first dose of study medication
Progression-free survival (in Phase 2 portion of study)
Time frame: Up to 12 months following the date of first dose of study medication
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Overall survival (in Phase 2 portion of study)
Time frame: 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)
Time frame: Up to 30 days after the last dose of study medication