Capecitabine/Tesetaxel Versus Capecitabine/Placebo as Second-line Therapy for Gastric Cancer (TESEGAST Trial)
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Genta Incorporated
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Capecitabine-tesetaxelExperimental Treatment2 Interventions
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
Group II: Capecitabine-placeboActive Control2 Interventions
21-day cycle; placebo orally once on Day 1; capecitabine 1750 mg/m2/day orally in 2 equally divided doses on Days 1-14
Capecitabine is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Xeloda for:
- Colorectal cancer
- Breast cancer
🇺🇸 Approved in United States as Xeloda for:
- Colorectal cancer
- Breast cancer
🇨🇦 Approved in Canada as Xeloda for:
- Colorectal cancer
- Breast cancer
🇯🇵 Approved in Japan as Xeloda for:
- Colorectal cancer
- Breast cancer
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
The University of Texas MD Anderson Cancer CenterHouston, TX
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Who is running the clinical trial?
Genta IncorporatedLead Sponsor