Expanded Access Study of TAS-102 for Patients with Advanced Colorectal Cancer
Sponsor: Taiho Oncology, Inc.
ClinicalTrials ID:NCT02286492
This study offers access to the drug TAS-102 for patients with advanced colorectal cancer who have not responded to standard treatments and are new to TAS-102 therapy.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this program is to provide the drug TAS-102 to patients with advanced colorectal cancer who have not responded to standard chemotherapy treatments. This includes patients who have not been treated with TAS-102 before and for whom this treatment is considered appropriate.
Description
This study is open-label, meaning both the doctors and patients know what treatment is being given. It aims to provide TAS-102 to patients with advanced colorectal cancer before it becomes widely available. Eligible patients are those who have already tried other standard treatments, such as chemotherapy and targeted therapies, but have not had success. The study will collect information on any serious side effects, whether or not they are related to TAS-102, as well as any pregnancies, overdoses, or medication errors. All side effects related to the study medication and any that lead to stopping the treatment will be recorded.
Eligibility Criteria
Inclusion Criteria
- Must provide written consent to participate.
- Must have a diagnosis of adenocarcinoma of the colon or rectum.
- Must have tried at least two standard chemotherapy treatments for advanced colorectal cancer without success.
- Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Must be able to take oral medications.
- Must have adequate function of bone marrow, kidneys, and liver.
- Women who can become pregnant must have a negative pregnancy test and agree to use effective birth control. Men must also agree to use effective birth control.
Exclusion Criteria
- Have certain serious illnesses or medical conditions.
- Have had recent treatments like major surgery, cancer therapy, or extensive radiation within specific time frames before starting the study drug.
- Have previously received TAS-102.
- Have unresolved side effects from previous treatments that are moderate or severe.
- Are pregnant or breastfeeding.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Alabama Oncology | 35211 | Birmingham | Alabama |
| Mayo Clinic | 85259 | Scottsdale | Arizona |
| California Cancer Associates for Research and Excellence | 93720 | Fresno | California |
| Global Cancer Research Institute (GCRI), Inc. | 95020 | Gilroy | California |
| USC Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| Pacific Hematology Oncology Associates (PHOA) | 94115 | San Francisco | California |
| Rocky Mountain Cancer Center | 80218 | Denver | Colorado |
| Yale Cancer Center | 06520 | New Haven | Connecticut |
| Georgetown Lombardi Comprehensive Cancer Center | 20007 | Washington | District of Columbia |
| University of Florida Health Davis Cancer Center | 32610 | Gainesville | Florida |
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