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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Taiho Oncology, Inc.
ClinicalTrials.gov Identifier:
NCT01607957
First received: May 24, 2012
Last updated: December 13, 2013
Last verified: December 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:


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. ] [ Designated as safety issue: No ]

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. ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 800
Study Start Date: June 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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

  Hide Study Locations
Locations
United States, Arizona
Arizona Center for Cancer Care
Glendale, Arizona, United States, 85306
United States, California
California Cancer Associates for Research and Excellence
Fresno, California, United States, 93720
Ronald H. Yanagihara, MD
Gilroy, California, United States, 95020
LAC and USC Medical Center
Los Angeles, California, United States, 90033
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Pacific Hematology Oncology Associates
San Francisco, California, United States, 94115
San Jose Medical Group
San Jose, California, United States, 95124
Coastal Integrative Cancer Care
San Luis Obispo, California, United States, 93401
United States, Connecticut
Yale Cancer Center
New Haven, Connecticut, United States, 06520
United States, Florida
MD Anderson Cancer Center Orlando
Orlando, Florida, United States, 32806
United States, Illinois
Illinois Cancer Care, P.C.
Peoria, Illinois, United States, 61615
United States, Indiana
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States, 70809
Ochsner Clinic Fndtn
New Orleans, Louisiana, United States, 70121-2429
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106
United States, Missouri
Jefferson City Medical Group
Jefferson City, Missouri, United States, 65109-6023
Saint Luke's Cancer Institute
Kansas City, Missouri, United States, 64111
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States, 44718
Hickman Cancer Center at Flower Hospital
Sylvania, Ohio, United States, 43560
United States, Virginia
Hematology/Oncology Associates of Fredericksburg
Fredericksburg, Virginia, United States, 22408
Australia, New South Wales
Royal North Shore Hospital
Sydney, New South Wales, Australia, 2065
Australia, South Australia
The Queen Elisabeth Hospital
Woodville South, South Australia, Australia, 5011
Australia, Victoria
Austin Hospital
Heidelberg, Victoria, Australia, 3084
The Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Australia
Studley Rd, Heidelberg VIC
Melbourne, Australia, 3084
Sir Charles Gairdner Hospital
Perth, Australia, 6009
Austria
Krankenhaus der Barmherzigen Schwestern Linz
Linz, Austria, 4010
Klinikum Wels-Grieskirchen GmbH
Wels, Austria, 4600
Universitaet Wien
Wien, Austria, 1090
Wilhelminenspital Wien
Wien, Austria, 1160
Universitaetsklinik fur Innere Medizin
Wien, Austria, 1090
Belgium
Cliniques Universitaires UCL St. Luc
Brussels, Belgium, 1200
Erasme University Hospital-ULB-Brussels
Brussels, Belgium, B-1070
Grand Hospital de Charleroi
Charleroi, Belgium, 6000
Antwerp University Hospital
Edegem, Belgium, 2650
University Hospital Gent
Edegem, Belgium, 2650
University Hospital Gent
Gent, Belgium, 9000
Leuven University Hospital - Campus Gasthuiseberg
Leuven, Belgium, 3000
University Hospital Gasthuisberg
Leuven, Belgium, 3000
Czech Republic
Klinika onkologie a radioteraie, Facultni nemocnice Hradec Kralove
Hradec Kralove, Czech Republic, 50005
Institute of Oncology and Rehabilitation Ples
Nova Ves pod Plesi, Czech Republic, 26204
France
CHU de Becançon
Besancon, France, 25030
University Hospital of Bordeaux
Bordeaux, France, 33075
Centre Oscar Lambret
Lille, France, 59020
CRLC Val d'Aurelle
Montpellier, France, 34298
Hopital Saint Antoine
Paris cedex 12, France, 75571
Centre Eugene Marquis
Rennes cedex, France, 35042
Germany
Onkologische Schwerpunktpraxis Kurfuerstendamm
Berlin, Germany, 10707
Praxiskooperation Bonn-Euskirchen-Rheinbach
Bonn, Germany, 53123
Universitatsklinikum Carl Gustav Carus - Dresden
Dresden, Germany, 1307
Medizinische Klinik am Krankenhaus Nordwest GmbH
Frankfurt, Germany, 60488
Uniklinik der Martin-Luther-Universitaet Halle-Wittenberg
Halle (Saale), Germany, 6120
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Uniklinik Koeln
Koeln, Germany, 50937
Johannes Gutenberg Universität Mainz
Mainz, Germany, 55131
Interdisziplinaeres Tumorzentrum Mannheim
Mannheim, Germany, 68167
Staedtisches Klinikum Muenchen / Klinikum Neuperlach
Muenchen, Germany, 81737
Klinikum der Universität München - Großhadern
München, Germany, 81377
Klinikum Oldenburg gGmbH
Oldenburg, Germany, 26133
Universitaetsklinikum Ulm
Ulm, Germany, 89081
Ireland
Bon Secours Hospital
Cork, Ireland
Adelaide and Meath Hospital
Dublin, Ireland, 24
St. Vincent's University Hospital
Dublin, Ireland, 4
Italy
Fondazione Poliambulanza
Brescia, Lombardy, Italy, 25124
Universita Delgi Studi de Genova (UNIGE)- Azienda Ospedaliera. Universitaria "San Martino" (Ospedale San Martino)
Genova, Italy, 16132
A.O. Ospedale Niguarda Ca' Granda
Milan, Italy, 20162
Fondazione IRCCS Instituto Nazionale dei Tumori Milano
Milano, Italy, 20133
A.O. R.N. "A.Cardarelli"
Naples, Italy, 80131
Seconda Universita degli Studi de Napoli
Napoli, Italy, 80131
AOU San Luidi di Orbassano
Orbassano, Italy, 1010043
Azienda Ospedaliero
Pisa, Italy, 6756126
Arcispidale S Maria Nuova
Reggio Emilia, Italy, 42123
Ospedale di Rimini
Rimini, Italy, 47923
Ospedale di Sondrio
Sondrio, Italy, 23100
Japan
Aichi Cancer Center Hospital
Nagoya, Aichi, Japan, 4648681
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 277-0882
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 2778577
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, Japan, 7910280
KKR Sapporo Medical Center TONAN-Hospital
Sapporo, Hokkaido, Japan, 0600001
Hokkaido University Hospital
Sapporo, Hokkaido, Japan, 0608648
Kobe City Medical Center General Hospital
Kobe, Hyogo, Japan, 6500047
Tsukuba University Hospital
Tsukuba, Ibaraki, Japan, 3058576
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan, 2418515
Osaka Medical College Hospital
Takatsuki, Osaka, Japan, 5698686
Saitama Cancer Center
Kita-adachi-gun, Saitama, Japan, 3620806
Shizuoka Cancer Center
Sunto-gun, Shizuoka, Japan, 4118777
Jichi Medical University Hospital
Shimotsuke, Tochigi, Japan, 3290498
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 1040045
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo, Japan, 1358550
Keio University Hospital
Shinjuku-ku, Tokyo, Japan, 1608582
Chiba Cancer Center
Chiba, Japan, 2608717
National Hospital Organization Kyushu Cancer Center
Fukuoka, Japan, 8111395
Kumamoto University Hospital
Kumamoto, Japan, 8608556
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka, Japan, 5378511
Tokushima University Hospital
Tokushima, Japan, 7708503
Spain
Hospital Universitario Vall d'Hebrón
Barcelona, Spain, 8035
Hospital Arnau de Vilanova
Lleida, Spain, 25198
Hospital 12 de Octubre
Madrid, Spain, 28041
Fundacion Jimenez Diaz - Universidad Autonoma de Madrid
Madrid, Spain, 28040
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Hospital Carlos Haya
Malaga, Spain, 29010
Hospital Universitario Morales Messeguer
Murcia, Spain, 30008
Corporacion Sanitaria Parc Tauli
Sabadell, Spain, 8916
Hospital Universitario Virgen del Rocio
Sevilla, Spain, 41013
Hospital Clínico Universitario de Valencia
Valencia, Spain, 46010
Hospital General Universitario de Valencia
Valencia, Spain, 46014
Sweden
Karolinska University Hospital
Stockholm, Sweden, 17176
Akademiska Sjukhuset
Uppsala, Sweden, 75185
United Kingdom
Aberdeen Royal Infirmary
Aberdeen, United Kingdom, AB25 2ZN
University Hospitals Bristol NHS Foundation Trust
Bristol, United Kingdom, BS2 8ED
St James' Institute of Oncology
Leeds, United Kingdom, LS9 7TF
University College London Hospitals Foundation NHS Trust
London, United Kingdom, NW1 2PG
The Royal Marsden NHS Foundation Trust
Surrey, United Kingdom, SM2 5PT
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

No publications provided

Responsible Party: Taiho Oncology, Inc.
ClinicalTrials.gov Identifier: NCT01607957     History of Changes
Other Study ID Numbers: TPU-TAS-102-301, 2012-000109-66
Study First Received: May 24, 2012
Last Updated: December 13, 2013
Health Authority: United States: Food and Drug Administration
Japan: Pharmaceuticals and Medical Devices Agency

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

ClinicalTrials.gov processed this record on October 19, 2014