A Randomized, Double-blind Study of Capecitabine Plus Tesetaxel Versus Capecitabine Plus Placebo as Second-line Therapy in Subjects With Gastric Cancer
Overview
- Phase
- Phase 2
- Intervention
- Tesetaxel
- Conditions
- Gastric Carcinoma
- Sponsor
- Genta Incorporated
- Enrollment
- 580
- Locations
- 3
- Primary Endpoint
- Overall survival
- Last Updated
- 13 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Capecitabine-tesetaxel
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
Intervention: Tesetaxel
Capecitabine-tesetaxel
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
Intervention: Capecitabine
Capecitabine-placebo
21-day cycle; placebo orally once on Day 1; capecitabine 1750 mg/m2/day orally in 2 equally divided doses on Days 1-14
Intervention: Placebo
Capecitabine-placebo
21-day cycle; placebo orally once on Day 1; capecitabine 1750 mg/m2/day orally in 2 equally divided doses on Days 1-14
Intervention: Capecitabine
Outcomes
Primary Outcomes
Overall survival
Time Frame: 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 Outcomes
- Disease control rate(Estimated will be assessed 12 months after the date of randomization of the last patient)
- Progression-free survival(Estimated will be assessed 12 months after the date of randomization of the last patient)
- Response rate in patients with measurable disease(Estimated will be assessed 12 months after the date of randomization of the last patient)
- Incidence of adverse events(Through 30 days after the last dose of study medication)