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

August 30, 2024 updated by: Taiho Oncology, Inc.

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.

Study Overview

Status

Approved for marketing

Conditions

Intervention / Treatment

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taiho Oncology, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 5, 2014

First Submitted That Met QC Criteria

November 5, 2014

First Posted (Estimated)

November 7, 2014

Study Record Updates

Last Update Posted (Actual)

September 5, 2024

Last Update Submitted That Met QC Criteria

August 30, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TO-TAS-102-401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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