A Phase I Study of TAS-102 in Patients With Advanced Gastrointestinal Tumors.
Completed · Phase 1
Conditions studied: Advanced Gastrointestinal Tumors
In brief
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.
Key facts
- Study ID
- NCT01916447
- Run by
- Taiho Oncology, Inc.
- People needed
- 65
- Starts
- 2013-09-01
- Expected to finish
- 2017-09-01
- Last updated by the study team
- 2024-09-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Los Angeles Clinical Site — Los Angeles, California, United States
- Chicago Clinical Site — Chicago, Illinois, United States
- Memorial Sloan-Kettering Cancer Center — New York, New York, United States
- Vanderbilt Ingram Cancer Center — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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