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Expanded Access Study of TAS-102 in Patients With Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT02286492
Expanded Access Status : Approved for marketing
First Posted : November 7, 2014
Last Update Posted : June 13, 2016
Sponsor:
Information provided by (Responsible Party):
Taiho Oncology, Inc.

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 in whom therapy with TAS-102 is clinically indicated.

Condition or disease Intervention/treatment
Colorectal Cancer Metastatic Drug: TAS-102

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 Type : Expanded Access
Official Title: An Open-Label Expanded Access Study of TAS-102 in Patients With Metastatic Colorectal Cancer Refractory to or Failing Standard Chemotherapy

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: TAS-102
    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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  1. Has provided written informed consent
  2. Has adenocarcinoma of the colon or rectum
  3. Has failed at least 2 prior regimens of standard chemotherapies for metastatic colorectal cancer
  4. ECOG performance status of 0 or 1
  5. Is able to take medications orally
  6. Has adequate organ function (bone marrow, kidney and liver)
  7. 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 Criteria:

  1. Certain serious illnesses or medical condition(s)
  2. 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
  3. Has received TAS-102
  4. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies
  5. Is a pregnant or lactating female

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02286492


  Hide Study Locations
Locations
United States, Alabama
Alabama Oncology
Birmingham, Alabama, United States, 35211
United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85259
United States, California
California Cancer Associates for Research and Excellence
Fresno, California, United States, 93720
Global Cancer Research Institute (GCRI), Inc.
Gilroy, California, United States, 95020
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Pacific Hematology Oncology Associates (PHOA)
San Francisco, California, United States, 94115
United States, Colorado
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80218
United States, Connecticut
Yale Cancer Center
New Haven, Connecticut, United States, 06520
United States, District of Columbia
Georgetown Lombardi Comprehensive Cancer Center
Washington, District of Columbia, United States, 20007
United States, Florida
University of Florida Health Davis Cancer Center
Gainesville, Florida, United States, 32610
Ocala Oncology Center
Ocala, Florida, United States, 34471
United States, Georgia
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Illinois CancerCare, P.C.
Peoria, Illinois, United States, 61615-7828
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Michigan
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
United States, New York
University of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Gabrail Cancer Center Research
Canton, Ohio, United States, 44718
The Mark H. Zangmeister Center
Columbus, Ohio, United States, 43219
United States, Pennsylvania
Hematology and Oncology Associates of Northeastern Pennsylvania
Dunmore, Pennsylvania, United States, 18512
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Texas
Texas Oncology Sammons Cancer Center
Dallas, Texas, United States, 75246
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
United States, Wisconsin
Fox Valley Hematology & Oncology
Appleton, Wisconsin, United States, 54915
Sponsors and Collaborators
Taiho Oncology, Inc.

Responsible Party: Taiho Oncology, Inc.
ClinicalTrials.gov Identifier: NCT02286492     History of Changes
Other Study ID Numbers: TO-TAS-102-401
First Posted: November 7, 2014    Key Record Dates
Last Update Posted: June 13, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases