Colorectal Cancer MetastaticNCT02286492
Expanded Access Study of TAS-102 in Patients With Metastatic Colorectal Cancer
A study testing TAS-102 in people with Colorectal Cancer Metastatic, run by Taiho Oncology, Inc. at 33 sites in United States.
Trial 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 in whom therapy with TAS-102 is clinically indicated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic
- What is being tested?
- TAS-102
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 33 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
United States33 sites
University of Michigan Hospital
Ann Arbor, Michigan, 48109
Fox Valley Hematology & Oncology
Appleton, Wisconsin, 54915
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
Alabama Oncology
Birmingham, Alabama, 35211
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Gabrail Cancer Center Research
Canton, Ohio, 44718
The University of Chicago
Chicago, Illinois, 60637
The Mark H. Zangmeister Center
Columbus, Ohio, 43219
Texas Oncology Sammons Cancer Center
Dallas, Texas, 75246
Rocky Mountain Cancer Center
Denver, Colorado, 80218
Karmanos Cancer Institute
Detroit, Michigan, 48201
Hematology and Oncology Associates of Northeastern Pennsylvania
Dunmore, Pennsylvania, 18512
California Cancer Associates for Research and Excellence
Fresno, California, 93720
University of Florida Health Davis Cancer Center
Gainesville, Florida, 32610
Global Cancer Research Institute (GCRI), Inc.
Gilroy, California, 95020
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
Yale Cancer Center
New Haven, Connecticut, 06520
Ocala Oncology Center
Ocala, Florida, 34471
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Illinois CancerCare, P.C.
Peoria, Illinois, 61615-7828
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Mayo Clinic
Rochester, Minnesota, 55905
University of Rochester
Rochester, New York, 14642
Pacific Hematology Oncology Associates (PHOA)
San Francisco, California, 94115
Mayo Clinic
Scottsdale, Arizona, 85259
Seattle Cancer Care Alliance
Seattle, Washington, 98109
Georgetown Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, 20007
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
Official title: An Open-Label Expanded Access Study of TAS-102 in Patients With Metastatic Colorectal Cancer Refractory to or Failing Standard Chemotherapy
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 in whom therapy with TAS-102 is clinically indicated.
Read the 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 candidates for fluoropyrimidine-, irinotecan-, and oxaliplatin-based chemotherapy, an anti-vascular endothelial growth factor (VEGF) therapy, and an anti-epidermal growth factor receptor (EGFR) therapy.
Serious adverse event information (whether or not related to TAS-102) as well as reports of pregnancy, overdose, or medication error will reported. In addition, all grades of adverse drug reactions (ADRs, adverse events related to study medication) and any adverse event that results in treatment discontinuation will be recorded as study data on CRFs.
- Conditions
- Colorectal Cancer Metastatic
- Being tested
- TAS-102
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAS-102Drug
At a dose of 35 mg/m2 administered orally twice daily for 5 days a week with 2 days rest for 14 days, followed by a 14-day rest (1 treatment cycle)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Taiho Oncology, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Taiho Oncology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02286492
- Sponsor's protocol ID
- TO-TAS-102-401
- Status last verified
- Aug 2024
- First submitted
- 5 Nov 2014
- Last updated
- 5 Sep 2024
- Results posted
- No
Publications
Mayer RJ, Hochster HS, Cohen SJ, Winkler R, Makris L, Grothey A. Safety of trifluridine/tipiracil in an open-label expanded-access program in elderly and younger patients with metastatic colorectal cancer. Cancer Chemother Pharmacol. 2018 Dec;82(6):961-969. doi: 10.1007/s00280-018-3686-5. Epub 2018 Oct 22.
PubMed 30350179
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Expanded Access Study of TAS-102 in Patients With Metastatic Colorectal Cancer Refractory to or Failing Standard Chemotherapy
- ClinicalTrials.gov ID
- NCT02286492
- Acronym / sponsor ID
- TO-TAS-102-401
- Conditions
- Colorectal Cancer Metastatic
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Taiho Oncology, Inc.Industry (pharma, biotech, devices)
- First posted
- 7 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 in whom therapy with TAS-102 is clinically indicated.
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 candidates for fluoropyrimidine-, irinotecan-, and oxaliplatin-based chemotherapy, an anti-vascular endothelial growth factor (VEGF) therapy, and an anti-epidermal growth factor receptor (EGFR) therapy.
Serious adverse event information (whether or not related to TAS-102) as well as reports of pregnancy, overdose, or medication error will reported. In addition, all grades of adverse drug reactions (ADRs, adverse events related to study medication) and any adverse event that results in treatment discontinuation will be recorded as study data on CRFs.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAS-102At a dose of 35 mg/m2 administered orally twice daily for 5 days a week with 2 days rest for 14 days, followed by a 14-day rest (1 treatment cycle) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Derived from this study: PubMed 30350179Mayer RJ, Hochster HS, Cohen SJ, Winkler R, Makris L, Grothey A. Safety of trifluridine/tipiracil in an open-label expanded-access program in elderly and younger patients with metastatic colorectal cancer. Cancer Chemother Pharmacol. 2018 Dec;82(6):961-969. doi: 10.1007/s00280-018-3686-5. Epub 2018 Oct 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAS-102 in people with Colorectal Cancer Metastatic, run by Taiho Oncology, Inc. at 33 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02286492, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024.