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

Colorectal Cancer Metastatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Approved for marketing

Administrative data

• NCT number: NCT02286492
• Other study ID #: TO-TAS-102-401
• Status: Approved for marketing
• Phase: N/A
• First received: November 5, 2014
• Last updated: June 9, 2016

Study information

• Verified date: June 2016
• Source: Taiho Oncology, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Expanded Access

Clinical 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.

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.

Recruitment information / eligibility

• Status: Approved for marketing
• Enrollment: 0
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Colorectal Cancer Metastatic
• Colorectal Neoplasms

Intervention

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)

Locations

Country	Name	City	State
United States	University of Michigan Hospital	Ann Arbor	Michigan
United States	Fox Valley Hematology & Oncology	Appleton	Wisconsin
United States	Winship Cancer Institute of Emory University	Atlanta	Georgia
United States	Alabama Oncology	Birmingham	Alabama
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Gabrail Cancer Center Research	Canton	Ohio
United States	The University of Chicago	Chicago	Illinois
United States	The Mark H. Zangmeister Center	Columbus	Ohio
United States	Texas Oncology Sammons Cancer Center	Dallas	Texas
United States	Rocky Mountain Cancer Center	Denver	Colorado
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	Hematology and Oncology Associates of Northeastern Pennsylvania	Dunmore	Pennsylvania
United States	California Cancer Associates for Research and Excellence	Fresno	California
United States	University of Florida Health Davis Cancer Center	Gainesville	Florida
United States	Global Cancer Research Institute (GCRI), Inc.	Gilroy	California
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	USC Norris Comprehensive Cancer Center	Los Angeles	California
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Yale Cancer Center	New Haven	Connecticut
United States	Ocala Oncology Center	Ocala	Florida
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Illinois CancerCare, P.C.	Peoria	Illinois
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Rochester	Rochester	New York
United States	Pacific Hematology Oncology Associates (PHOA)	San Francisco	California
United States	Mayo Clinic	Scottsdale	Arizona
United States	Seattle Cancer Care Alliance	Seattle	Washington
United States	Georgetown Lombardi Comprehensive Cancer Center	Washington	District of Columbia
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Taiho Oncology, Inc.

Country where clinical trial is conducted

United States,