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

Description

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 Start Date

Not specified

Estimated Completion Date

Not specified

Interventions

  • Drug: TAS-102

Specialties

  • Internal Medicine: Hematology/Oncology
  • Oncology: Colorectal Cancer/Polyps
  • Physician Assistant: Clinical Pharmacology,Hematology/Oncology

MeSH Terms

  • Colorectal Neoplasms
  • TAS-102

Study ID

Taiho Oncology, Inc. -- TO-TAS-102-401

Status

Available

Trial ID

NCT02286492

Study Type

Expanded Access

Trial Phase

N/A

Enrollment Quota

Not Listed

Sponsor

Taiho Oncology, Inc.

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Not Listed

Study Locations and Contact Information (50)

Study Location Distance Name Phone Email
Yale Cancer Center - New Haven, Connecticut 18.1 miles None None None
Yale Cancer Center - New Haven, Connecticut 18.1 miles None None None
Rutgers Cancer Institute of New Jersey - New Brunswick, New Jersey 80.6 miles None None None
Rutgers Cancer Institute of New Jersey - New Brunswick, New Jersey 80.6 miles None None None
Hematology and Oncology Associates of Northeastern Pennsylvania - Dunmore, Pennsylvania 124.3 miles None None None
Hematology and Oncology Associates of Northeastern Pennsylvania - Dunmore, Pennsylvania 124.3 miles None None None
Fox Chase Cancer Center - Philadelphia, Pennsylvania 125.3 miles None None None
DanaFarber Cancer Institute - Boston, Massachusetts 135.8 miles None None None
Massachusetts General Hospital - Boston, Massachusetts 137.9 miles None None None
Massachusetts General Hospital - Boston, Massachusetts 137.9 miles None None None
Dartmouth Hitchcock Medical Center - Lebanon, New Hampshire 175.0 miles None None None
Georgetown Lombardi Comprehensive Cancer Center - Washington, District of Columbia 258.0 miles None None None
Georgetown Lombardi Comprehensive Cancer Center - Washington, District of Columbia 258.0 miles None None None
University of Rochester - Rochester, New York 260.4 miles None None None
University of Pittsburgh Medical Center - Pittsburgh, Pennsylvania 354.1 miles None None None
Gabrail Cancer Center Research - Canton, Ohio 428.6 miles None None None
Gabrail Cancer Center Research - Canton, Ohio 428.6 miles None None None
Karmanos Cancer Institute - Detroit, Michigan 512.3 miles None None None
Karmanos Cancer Institute - Detroit, Michigan 512.3 miles None None None
The Mark H Zangmeister Center - Columbus, Ohio 515.7 miles None None None
The Mark H Zangmeister Center - Columbus, Ohio 515.7 miles None None None
Wake Forest Baptist Health - Winston-Salem, North Carolina 523.1 miles None None None
Wake Forest Baptist Health - Winston-Salem, North Carolina 523.1 miles None None None
University of Michigan Hospital - Ann Arbor, Michigan 545.4 miles None None None
The University of Chicago - Chicago, Illinois 744.7 miles None None None
Winship Cancer Institute of Emory University - Atlanta, Georgia 795.6 miles None None None
Fox Valley Hematology Oncology - Appleton, Wisconsin 798.4 miles None None None
Fox Valley Hematology Oncology - Appleton, Wisconsin 798.4 miles None None None
VanderbiltIngram Cancer Center - Nashville, Tennessee 811.9 miles None None None
VanderbiltIngram Cancer Center - Nashville, Tennessee 811.9 miles None None None
Alabama Oncology - Birmingham, Alabama 919.9 miles None None None
Alabama Oncology - Birmingham, Alabama 919.9 miles None None None
University of Florida Health Davis Cancer Center - Gainesville, Florida 951.0 miles None None None
University of Florida Health Davis Cancer Center - Gainesville, Florida 951.0 miles None None None
Ocala Oncology Center - Ocala, Florida 972.0 miles None None None
Mayo Clinic - Rochester, Minnesota 997.5 miles None None None
Mayo Clinic - Rochester, Minnesota 997.5 miles None None None
University of Nebraska Medical Center - Omaha, Nebraska 1,182.2 miles None None None
Texas Oncology Sammons Cancer Center - Dallas, Texas 1,420.1 miles None None None
Rocky Mountain Cancer Center - Denver, Colorado 1,665.3 miles None None None
Rocky Mountain Cancer Center - Denver, Colorado 1,665.3 miles None None None
Mayo Clinic - Scottsdale, Arizona 2,167.5 miles None None None
Mayo Clinic - Scottsdale, Arizona 2,167.5 miles None None None
Seattle Cancer Care Alliance - Seattle, Washington 2,427.3 miles None None None
USC Norris Comprehensive Cancer Center - Los Angeles, California 2,487.5 miles None None None
California Cancer Associates for Research and Excellence - Fresno, California 2,491.0 miles None None None
California Cancer Associates for Research and Excellence - Fresno, California 2,491.0 miles None None None
Global Cancer Research Institute GCRI Inc - Gilroy, California 2,579.9 miles None None None
Global Cancer Research Institute GCRI Inc - Gilroy, California 2,579.9 miles None None None
Pacific Hematology Oncology Associates PHOA - San Francisco, California 2,604.7 miles None None None

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