Status:
COMPLETED
A Phase I Study of TAS-102 in Patients With Advanced Gastrointestinal Tumors.
Lead Sponsor:
Taiho Oncology, Inc.
Conditions:
Advanced Gastrointestinal Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to investigate the safety and determine the maximum tolerated dose of TAS-102 administered in combination with CPT-11 in patients with advanced gastrointestinal tumors.
Detailed Description
This is an open-label, non-randomized, dose-escalation, Phase 1 study of TAS-102 administered in combination with CPT-11. The study will be conducted in 2 parts: a Dose Escalation Phase (Part 1) to de...
Eligibility Criteria
Inclusion
- Has provided written informed consent
- Has advanced gastrointestinal tumors refractory to at least 1 chemotherapy
- ECOG performance status of 0 or 1
- Is able to take medications orally
- Has adequate organ function (bone marrow, kidney and liver)
- Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control.
Exclusion
- Has had certain other recent treatment e.g. major surgery, extended field radiation, anticancer therapy, received investigational agent, within the specified time frames prior to study drug administration
- Presence of serious illnesses or medical condition(s) e.g. brain metastases, systemic infection, heart failure
- Has unresolved toxicity of greater than or equal to CTCAE Grade 1 attributed to any prior therapies
- Known sensitivity to TAS-102, CPT-11, Bevacizumab, or their components
- Is a pregnant or lactating female
- Has had either partial or total gastrectomy
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2017
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT01916447
Start Date
September 1 2013
End Date
September 1 2017
Last Update
September 5 2024
Active Locations (4)
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1
Los Angeles Clinical Site
Los Angeles, California, United States, 90095
2
Chicago Clinical Site
Chicago, Illinois, United States, 60611
3
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
4
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, United States, 37212