Tesetaxel as Second-line Therapy for Patients With Advanced Gastric Cancer
Phase 2
- Conditions
- Adenocarcinoma of the StomachAdenocarcinoma of Esophagogastric Junction
- Registration Number
- NCT01095120
- Lead Sponsor
- Genta Incorporated
- Brief Summary
Tesetaxel is an orally administered chemotherapy agent of the taxane class. This study is being undertaken to evaluate the efficacy and safety of tesetaxel administered as second-line therapy to patients with advanced gastric cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 27
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Response rate (Response Evaluation Criteria In Solid Tumors (RECIST)) 12 months from date of first dose of study medication
- Secondary Outcome Measures
Name Time Method Disease control rate (ie, the percentage of patients with a confirmed complete or partial response [of any duration] or stable disease at least 6 weeks in duration) 12 months from date of first dose of study medication Durable response rate (ie, the proportion of patients with a confirmed complete or partial response at least 6 months in duration) 12 months from date of first dose of study medication Duration of response 12 months from date of first dose of study medication Adverse events Through 30 days post last dose of study medication
Trial Locations
- Locations (4)
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Northwestern Medical Faculty Foundation
🇺🇸Chicago, Illinois, United States
Abramson Cancer of the University of Pennsylvania at Perelman Center for Advanced Medicine
🇺🇸Philadelphia, Pennsylvania, United States
The University of Texax MD Anderson Cancer Center
🇺🇸Houston, Texas, United States