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Randomized, Double-blind, Phase 3 Study of TAS-102 Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

Thank you

Trial Information

Randomized, Double-blind, Phase 3 Study of TAS-102 Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies


This is a multinational, double-blind, two-arm, parallel, randomized Phase 3 comparison
study evaluating the efficacy and safety of TAS-102 versus placebo in patients with
refractory metastatic colorectal cancer. Patients will be randomly assigned (2:1) to TAS-102
(experimental arm) or placebo (control arm).


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

Every 8 weeks. Survival status should be collected for up to 12 months after the last patient is randomized or until the target number of events (deaths) is met, whichever is later.

Safety Issue:

No

Principal Investigator

Robert J Mayer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

TPU-TAS-102-301

NCT ID:

NCT01607957

Start Date:

June 2012

Completion Date:

December 2014

Related Keywords:

  • Colorectal Cancer
  • Refractory, metastatic colorectal cancer
  • Colorectal Neoplasms

Name

Location
MD Anderson Cancer Center Orlando Orlando, Florida  32806
Mary Bird Perkins Cancer Center Baton Rouge, Louisiana  70809
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Yale Cancer Center New Haven, Connecticut  06520-8028
Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756
St. Joseph Mercy Hospital Pontiac, Michigan  48341-2985
Pacific Hematology Oncology Associates San Francisco, California  94115
Gabrail Cancer Center Canton, Ohio  44718
Saint Luke's Cancer Institute Kansas City, Missouri  64111
Indiana University Simon Cancer Center Indianapolis, Indiana  46202
Arizona Center for Cancer Care Glendale, Arizona  85306
Illinois Cancer Care, P.C. Peoria, Illinois  61547
Coastal Integrative Cancer Care San Luis Obispo, California  93401
California Cancer Associates for Research and Excellence Fresno, California  93720
San Jose Medical Group San Jose, California  95116
Ronald H. Yanagihara, MD Gilroy, California  95020
Jefferson City Medical Group Jefferson City, Missouri  65109-6023
Hematology/Oncology Associates of Fredericksburg Fredericksburg, Virginia  22408