Study of TAS-102 or Placebo Plus BSC in Patients With Metastatic Gastric Cancer
Launched by TAIHO ONCOLOGY, INC. · Jul 14, 2015
Trial Information
Current as of June 03, 2025
Completed
Keywords
ClinConnect Summary
This is a multinational, double-blind, two-arm, parallel, randomized, Phase 3 study evaluating the efficacy and safety of TAS-102 plus BSC versus placebo plus BSC in participants with metastatic gastric cancer who have previously received at least 2 prior regimens for advanced disease. Eligible participants will be centrally randomized (2:1) to TAS-102 + BSC (experimental arm) or placebo + BSC (control arm).
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Has histologically confirmed non-resectable, metastatic gastric adenocarcinoma including adenocarcinoma of the gastroesophageal junction.
- • 2. Has previously received at least 2 prior regimens for advanced disease and were refractory to or unable to tolerate their last prior therapy.
- • 3. Has measureable or nonmeasurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
- • 4. Is able to take medications orally (ie, no feeding tube).
- • 5. Has an Eastern Cooperative Oncology Group performance status of 0 or 1.
- • 6. Has adequate organ function as defined by protocol defined labs.
- • 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. Has certain serious illnesses or medical conditions
- • 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 previously received TAS-102.
- • 4. Has unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse Events Grade 2 attributed to any prior therapies.
- • 5. Is a pregnant or lactating female.
About Taiho Oncology, Inc.
Taiho Oncology, Inc. is a leading biopharmaceutical company dedicated to the development and commercialization of innovative oncology therapies. With a focus on addressing unmet medical needs in cancer treatment, Taiho Oncology leverages cutting-edge research and advanced drug development processes to bring novel therapeutics to patients. The company is committed to enhancing patient outcomes through collaboration with healthcare professionals, research institutions, and patient advocacy groups, while maintaining the highest standards of safety and efficacy in its clinical trials. Through its robust pipeline of targeted therapies and combination treatments, Taiho Oncology aims to make significant contributions to the fight against cancer.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Ann Arbor, Michigan, United States
Lexington, Kentucky, United States
Milwaukee, Wisconsin, United States
Chicago, Illinois, United States
New York, New York, United States
Holon, , Israel
Chicago, Illinois, United States
Madrid, , Spain
Oviedo, , Spain
Berkeley, California, United States
Paris, , France
Rozzano (Mi), , Italy
Madison, Wisconsin, United States
Los Angeles, California, United States
Chicago, Illinois, United States
Hannover, , Germany
Providence, Rhode Island, United States
Genova, , Italy
Corpus Christi, Texas, United States
Kashiwa, Chiba, Japan
Utsunomiya, Tochigi, Japan
Lyon, , France
Madrid, , Spain
Leicester, , United Kingdom
Waterford, , Ireland
Leuven, , Belgium
Hamburg, , Germany
Ramat Gan, , Israel
Marseille, , France
Hannover, Niedersachsen, Germany
Sutton, , United Kingdom
Barcelona, , Spain
Osaka Shi, Osaka, Japan
Kraków, , Poland
Marseille, , France
Manchester, , United Kingdom
Milwaukee, Wisconsin, United States
Minsk, , Belarus
Kasama, Ibaraki, Japan
Murcia, , Spain
Moscow, , Russian Federation
Saint Herblain, , France
Fullerton, California, United States
Winston Salem, North Carolina, United States
Ulm, , Germany
Cremona, , Italy
Dublin, , Ireland
London, , United Kingdom
Rennes Cedex, , France
Montpellier, , France
Charleroi, , Belgium
Haifa, , Israel
Los Angeles, California, United States
Gilbert, Arizona, United States
Brescia, , Italy
Cordoba, , Spain
London, , United Kingdom
ōta, Gunma, Japan
Holon, , Israel
Schweinfurt, , Germany
Olomouc, , Czechia
Porto, , Portugal
Ankara, , Turkey
Lebanon, New Hampshire, United States
Bergamo, , Italy
Northwood, Middlesex, United Kingdom
Praha, , Czechia
Rochester, New York, United States
Milan, , Italy
Bursa, , Turkey
Lodz, , Poland
Los Angeles, California, United States
San Francisco, California, United States
Jacksonville, Florida, United States
Peoria, Illinois, United States
New York, New York, United States
Pittsburgh, Pennsylvania, United States
Madison, Wisconsin, United States
Gomel, , Belarus
Minsk, , Belarus
Brussels, , Belgium
Edegem, , Belgium
Montreal, , Canada
Brno, , Czechia
Hradec Králové, , Czechia
Praha, , Czechia
Angers Cedex 9, , France
Paris, , France
Perpignan, , France
Pessac, , France
Muenchen, Bayern, Germany
Berlin, , Germany
Muenchen, , Germany
Dublin 24, , Ireland
Beersheba, , Israel
Jerusalem, , Israel
Petah Tikva, , Israel
Ramat Gan, , Israel
Ramat Gan, , Israel
Aviano (Pn), , Italy
Firenze, , Italy
Meldola (Fc), , Italy
Milano, , Italy
Napoli, , Italy
Orbassano (To), , Italy
Pisa, , Italy
Potenza, , Italy
Sondrio, , Italy
Osaka Shi, Osaka, Japan
Sakai, Osaka, Japan
Tōyama, Toyama, Japan
Morioka, , Japan
Katowice, , Poland
Olsztyn, , Poland
Opole, , Poland
Warszawa, , Poland
Matosinhos, Porto, Portugal
Almada, Setubal, Portugal
Braga, , Portugal
Lisboa, , Portugal
Lisboa, , Portugal
Porto, , Portugal
Porto, , Portugal
Vila Real, , Portugal
Craiova, Dolj, Romania
Suceava, , Romania
Nizhniy Novgorod, , Russian Federation
Omsk, , Russian Federation
Saint Petersburg, , Russian Federation
Saint Petersburg, , Russian Federation
Saint Petersburg, , Russian Federation
Ufa, , Russian Federation
Sabadell, , Spain
Adana, , Turkey
Ankara, , Turkey
Ankara, , Turkey
Ankara, , Turkey
Edirne, , Turkey
İstanbul, , Turkey
Istanbul, , Turkey
İstanbul, , Turkey
Izmir, , Turkey
Aberdeen, Scotland, United Kingdom
Belfast, , United Kingdom
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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