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Anti-metabolites
Capecitabine-tesetaxel for Stomach Cancer (TESEGAST Trial)
Phase 2
Waitlist Available
Research Sponsored by Genta Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 30 days after the last dose of study medication
Awards & highlights
TESEGAST Trial 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.
Eligible Conditions
- Stomach Cancer
TESEGAST Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through 30 days after the last dose of study medication
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 30 days after the last dose of study medication
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival
Secondary outcome measures
Disease control rate
Incidence of adverse events
Progression-free survival
+1 moreTESEGAST Trial Design
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tesetaxel
Not yet FDA approved
Capecitabine
FDA approved
Find a Location
Who is running the clinical trial?
Genta IncorporatedLead Sponsor
30 Previous Clinical Trials
1,090 Total Patients Enrolled
Jaffer Ajani, MDStudy ChairThe University of Texas MD Anderson Cancer Center
8 Previous Clinical Trials
1,335 Total Patients Enrolled
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