Study of TAS-102 in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies (RECOURSE)
This study is currently recruiting participants.
Verified December 2012 by Taiho Pharma USA, Inc.
Sponsor:
Taiho Pharma USA, Inc.
Information provided by (Responsible Party):
Taiho Pharma USA, Inc.
ClinicalTrials.gov Identifier:
NCT01607957
First received: May 24, 2012
Last updated: December 21, 2012
Last verified: December 2012
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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 Pharma USA, 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:
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01607957
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Contacts
| Contact: Manuel Aivado, MD, PhD | 855-598-8259 | aivado@taihopui.com |
| Contact: Takekazu Aoyama, MD, PhD | 855-598-8259 | aoyama@taihopui.com |
Hide Study LocationsLocations
| United States, Arizona | |
| Arizona Center for Cancer Care | Recruiting |
| Glendale, Arizona, United States, 85306 | |
| United States, California | |
| California Cancer Associates for Research and Excellence | Recruiting |
| Fresno, California, United States, 93720 | |
| Ronald H. Yanagihara, MD | Recruiting |
| Gilroy, California, United States, 95020 | |
| Pacific Hematology Oncology Associates | Recruiting |
| San Francisco, California, United States, 94115 | |
| San Jose Medical Group | Recruiting |
| San Jose, California, United States, 95124 | |
| Coastal Integrative Cancer Care | Recruiting |
| San Luis Obispo, California, United States, 93401 | |
| United States, Connecticut | |
| Yale Cancer Center | Recruiting |
| New Haven, Connecticut, United States, 06520 | |
| United States, Florida | |
| MD Anderson Cancer Center Orlando | Recruiting |
| Orlando, Florida, United States, 32806 | |
| United States, Illinois | |
| Illinois Cancer Care, P.C. | Recruiting |
| Peoria, Illinois, United States, 61615 | |
| United States, Indiana | |
| Indiana University Simon Cancer Center | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Louisiana | |
| Mary Bird Perkins Cancer Center | Recruiting |
| Baton Rouge, Louisiana, United States, 70809 | |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | Not yet recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Dana-Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| United States, Michigan | |
| St. Joseph Mercy Hospital | Recruiting |
| Ann Arbor, Michigan, United States, 48106 | |
| United States, Missouri | |
| Jefferson City Medical Group | Recruiting |
| Jefferson City, Missouri, United States, 65109-6023 | |
| Saint Luke's Cancer Institute | Recruiting |
| Kansas City, Missouri, United States, 64111 | |
| United States, New Hampshire | |
| Dartmouth-Hitchcock Medical Center | Recruiting |
| Lebanon, New Hampshire, United States, 03756 | |
| United States, Ohio | |
| Gabrail Cancer Center | Recruiting |
| Canton, Ohio, United States, 44718 | |
| United States, Virginia | |
| Hematology/Oncology Associates of Fredericksburg | Recruiting |
| Fredericksburg, Virginia, United States, 22408 | |
| Australia, New South Wales | |
| Royal North Shore Hospital | Recruiting |
| Sydney, New South Wales, Australia, 2065 | |
| Australia, South Australia | |
| The Queen Elisabeth Hospital | Recruiting |
| Woodville South, South Australia, Australia, 5011 | |
| Australia, Victoria | |
| Austin Hospital | Recruiting |
| Heidelberg, Victoria, Australia, 3084 | |
| The Royal Melbourne Hospital | Recruiting |
| Parkville, Victoria, Australia, 3050 | |
| Austria | |
| Krankenhaus der Barmherzigen Schwestern Linz | Recruiting |
| Linz, Austria, 4010 | |
| Klinikum Wels-Grieskirchen GmbH | Recruiting |
| Wels, Austria, 4600 | |
| Wilhelminenspital Wien | Recruiting |
| Wien, Austria, 1160 | |
| Universitaetsklinik fur Innere Medizin | Recruiting |
| Wien, Austria, 1090 | |
| Belgium | |
| Cliniques Universitaires UCL St. Luc | Recruiting |
| Brussels, Belgium, 1200 | |
| Grand Hospital de Charleroi | Recruiting |
| Charleroi, Belgium, 6000 | |
| Antwerp University Hospital | Recruiting |
| Edegem, Belgium, 2650 | |
| University Hospital Gent | Recruiting |
| Gent, Belgium, 9000 | |
| Leuven University Hospital - Campus Gasthuiseberg | Recruiting |
| Leuven, Belgium, 3000 | |
| University Hospital Gasthuisberg | Not yet recruiting |
| Leuven, Belgium, 3000 | |
| France | |
| CHU de Becançon | Recruiting |
| Besancon, France, 25030 | |
| CRLC Val d'Aurelle | Recruiting |
| Montpellier, France, 34298 | |
| Ireland | |
| Bon Secours Hospital | Recruiting |
| Cork, Ireland | |
| St. Vincent's University Hospital | Recruiting |
| Dublin, Ireland, 4 | |
| Italy | |
| Fondazione Poliambulanza | Recruiting |
| Brescia, Lombardy, Italy, 25124 | |
| Universita Delgi Studi de Genova (UNIGE)- Azienda Ospedaliera. Universitaria "San Martino" (Ospedale San Martino) | Recruiting |
| Genova, Italy, 16132 | |
| A.O. Ospedale Niguarda Ca' Granda | Recruiting |
| Milan, Italy, 20162 | |
| AOU San Luidi di Orbassano | Recruiting |
| Orbassano, Italy, 1010043 | |
| Azienda Ospedaliero | Recruiting |
| Pisa, Italy, 6756126 | |
| Ospedale di Sondrio | Recruiting |
| Sondrio, Italy, 23100 | |
| Japan | |
| Aichi Cancer Center Hospital | Recruiting |
| Nagoya, Aichi, Japan, 4648681 | |
| National Cancer Center Hospital East | Recruiting |
| Kashiwa, Chiba, Japan, 277-0882 | |
| National Cancer Center Hospital East | Recruiting |
| Kashiwa, Chiba, Japan, 2778577 | |
| National Hospital Organization Shikoku Cancer Center | Recruiting |
| Matsuyama, Ehime, Japan, 7910280 | |
| KKR Sapporo Medical Center TONAN-Hospital | Recruiting |
| Sapporo, Hokkaido, Japan, 0600001 | |
| Hokkaido University Hospital | Recruiting |
| Sapporo, Hokkaido, Japan, 0608648 | |
| Kobe City Medical Center General Hospital | Recruiting |
| Kobe, Hyogo, Japan, 6500047 | |
| Tsukuba University Hospital | Recruiting |
| Tsukuba, Ibaraki, Japan, 3058576 | |
| Kanagawa Cancer Center | Recruiting |
| Yokohama, Kanagawa, Japan, 2418515 | |
| Osaka Medical College Hospital | Recruiting |
| Takatsuki, Osaka, Japan, 5698686 | |
| Saitama Cancer Center | Recruiting |
| Kita-adachi-gun, Saitama, Japan, 3620806 | |
| Shizuoka Cancer Center | Recruiting |
| Sunto-gun, Shizuoka, Japan, 4118777 | |
| Jichi Medical University Hospital | Recruiting |
| Shimotsuke, Tochigi, Japan, 3290498 | |
| National Cancer Center Hospital | Recruiting |
| Chuo-ku, Tokyo, Japan, 1040045 | |
| The Cancer Institute Hospital of Japanese Foundation for Cancer Research | Recruiting |
| Koto-ku, Tokyo, Japan, 1358550 | |
| Keio University Hospital | Recruiting |
| Shinjuku-ku, Tokyo, Japan, 1608582 | |
| Chiba Cancer Center | Recruiting |
| Chiba, Japan, 2608717 | |
| National Hospital Organization Kyushu Cancer Center | Recruiting |
| Fukuoka, Japan, 8111395 | |
| Kumamoto University Hospital | Recruiting |
| Kumamoto, Japan, 8608556 | |
| Osaka Medical Center for Cancer and Cardiovascular Diseases | Recruiting |
| Osaka, Japan, 5378511 | |
| Tokushima University Hospital | Recruiting |
| Tokushima, Japan, 7708503 | |
| Spain | |
| Hospital Universitario Ramon y Cajal | Recruiting |
| Madrid, Spain, 28034 | |
| Sweden | |
| Karolinska University Hospital | Recruiting |
| Stockholm, Sweden, 17176 | |
| Akademiska Sjukhuset | Recruiting |
| Uppsala, Sweden, 75185 | |
Sponsors and Collaborators
Taiho Pharma USA, 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 Pharma USA, 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 21, 2012 |
| Health Authority: | United States: Food and Drug Administration Japan: Pharmaceuticals and Medical Devices Agency |
Keywords provided by Taiho Pharma USA, 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 May 23, 2013