Status:
APPROVED_FOR_MARKETING
Expanded Access Study of TAS-102 in Patients With Metastatic Colorectal Cancer
Lead Sponsor:
Taiho Oncology, Inc.
Conditions:
Colorectal Cancer Metastatic
Eligibility:
All Genders
18+ years
Brief Summary
The objective of the program is to provide access to TAS-102 to patients with metastatic colorectal cancer who are refractory to or failing standard chemotherapy, are new to therapy with TAS-102 and i...
Detailed Description
This is an open-label study to provide expanded access to TAS-102 prior to its commercial availability for patients with metastatic colorectal cancer who have been previously treated with, or are not ...
Eligibility Criteria
Inclusion
- Has provided written informed consent
- Has adenocarcinoma of the colon or rectum
- Has failed at least 2 prior regimens of standard chemotherapies for metastatic colorectal cancer
- 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
- Certain serious illnesses or medical condition(s)
- Has had certain other recent treatment e.g. major surgery, anticancer therapy, extended field radiation, received investigational agent, within the specified time frames prior to study drug administration
- Has received TAS-102
- Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies
- Is a pregnant or lactating female
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02286492
Last Update
September 5 2024
Active Locations (33)
Enter a location and click search to find clinical trials sorted by distance.
1
Alabama Oncology
Birmingham, Alabama, United States, 35211
2
Mayo Clinic
Scottsdale, Arizona, United States, 85259
3
California Cancer Associates for Research and Excellence
Fresno, California, United States, 93720
4
Global Cancer Research Institute (GCRI), Inc.
Gilroy, California, United States, 95020