Study of TAS-102 in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies - Full Text View

Purpose

The purpose of this study is to compare the efficacy and safety of TAS-102 versus placebo in patients with refractory metastatic colorectal cancer.

Condition	Intervention	Phase
Colorectal Cancer	Drug: TAS-102 Drug: Placebo	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Colorectal Cancer

U.S. FDA Resources

Further study details as provided by Taiho Oncology, Inc.:

Primary Outcome Measures:

Overall survival [ 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. ]

Secondary Outcome Measures:

Progression-free survival [ Time Frame: Every 8 weeks. Tumor assessments will be performed until radiologic progression develops or the start of new anticancer treatment, for up to 12 months after the last patient is randomized or until the target number of events (deaths) is met. ]
Safety and tolerability evaluation will focus on adverse events and laboratory assessments [ Time Frame: Through 30 days following last administration of study medication or until initiation of new anticancer treatment ]


Estimated Enrollment:	800
Study Start Date:	June 2012
Estimated Study Completion Date:	April 2016
Estimated Primary Completion Date:	February 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: TAS-102	Drug: TAS-102 35 mg/m2/dose, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria are met.
Placebo Comparator: Placebo	Drug: Placebo Placebo tablets, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria are met.

Detailed Description:

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).

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01607957

Show 116 Study Locations

Sponsors and Collaborators

Taiho Oncology, Inc.

Investigators


Principal Investigator:	Robert J Mayer, MD	Dana-Farber Cancer Institute
Principal Investigator:	Eric Van Cutsem, MD	University Hospital, Gasthuisberg
Principal Investigator:	Atsushi Ohtsu, MD	National Cancer Center Hospital East

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Longo-Muñoz F, Argiles G, Tabernero J, Cervantes A, Gravalos C, Pericay C, Gil-Calle S, Mizuguchi H, Carrato-Mena A, Limón ML, Garcia-Carbonero R. Efficacy of trifluridine and tipiracil (TAS-102) versus placebo, with supportive care, in a randomized, controlled trial of patients with metastatic colorectal cancer from Spain: results of a subgroup analysis of the phase 3 RECOURSE trial. Clin Transl Oncol. 2017 Feb;19(2):227-235. doi: 10.1007/s12094-016-1528-7. Epub 2016 Jul 21.

Mayer RJ, Van Cutsem E, Falcone A, Yoshino T, Garcia-Carbonero R, Mizunuma N, Yamazaki K, Shimada Y, Tabernero J, Komatsu Y, Sobrero A, Boucher E, Peeters M, Tran B, Lenz HJ, Zaniboni A, Hochster H, Cleary JM, Prenen H, Benedetti F, Mizuguchi H, Makris L, Ito M, Ohtsu A; RECOURSE Study Group. Randomized trial of TAS-102 for refractory metastatic colorectal cancer. N Engl J Med. 2015 May 14;372(20):1909-19. doi: 10.1056/NEJMoa1414325.


Responsible Party:	Taiho Oncology, Inc.
ClinicalTrials.gov Identifier:	NCT01607957 History of Changes
Other Study ID Numbers:	TPU-TAS-102-301 2012-000109-66 ( EudraCT Number )
Study First Received:	May 24, 2012
Last Updated:	December 21, 2015

Keywords provided by Taiho Oncology, Inc.:


Refractory, metastatic colorectal cancer

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 Trifluridine Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents

ClinicalTrials.gov processed this record on August 18, 2017

Study of TAS-102 in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies (RECOURSE)