LOGiC - Lapatinib Optimization Study in ErbB2 (HER2) Positive Gastric Cancer: A Phase III Global, Blinded Study Designed to Evaluate Clinical Endpoints and Safety of Chemotherapy Plus Lapatinib
NCT ID: NCT00680901
Last Updated: 2025-08-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
545 participants
INTERVENTIONAL
2008-06-04
2024-10-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CapeOx plus Lapatinib
CapeOx plus Lapatinib
Lapatinib
5 pills at 250mg each once daily
Capecitabine
1700mg/m2/day in two daily doses
Oxaliplatin
130mg/m2 on day 1
CapeOx plus Placebo
CapeOx plus Placebo
Placebo
5 pills once daily
Capecitabine
1700mg/m2/day in two daily doses
Oxaliplatin
130mg/m2 on day 1
Interventions
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Lapatinib
5 pills at 250mg each once daily
Placebo
5 pills once daily
Capecitabine
1700mg/m2/day in two daily doses
Oxaliplatin
130mg/m2 on day 1
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Gastric cancer that is unresectable due to locally advanced (defined as stage IV: T4N1-3 or TanyN3), metastatic, or locally recurrent disease; Esophageal cancer that is unresectable due to locally advanced (T3N1 or T4Nany), metastatic or locally recurrent disease.
* Measurable or non-measurable, but radiologically evaluable disease, according to RECIST.
* HER2 amplification by FISH assessed by the local or designated central laboratory; Subjects with unknown HER2 status were not eligible.
* Adequate organ function, as defined in the study protocol, assessed within 14 days prior randomization.
* Cardiac ejection fraction within institutional range of normal as measured by echocardiogram (ECHO).
* Prior/Concurrent Therapy:
* At least 3 weeks following major surgery, such as gastrectomy, and were recovered from any related toxicity More than 5 years since prior chemotherapy for malignancy other than GC. At least 4 weeks since prior radiotherapy
* More than 5 years since prior biologic or hormonal therapy or immunotherapy for malignancy other than gastric carcinoma.
Exclusion Criteria
* Known history of active CNS disease.
* Uncontrolled ascites.
* Concurrent anti-cancer therapy (chemotherapy, radiation therapy other than for pain relief, immunotherapy, biologic therapy, hormonal therapy or surgery) while taking investigational treatment.
* Gastric carcinoid, epidermoid, sarcomas, or squamous cell carcinoma.
* Prior palliative chemotherapy for the treatment of gastric cancer.
* Prior treatment with oxaliplatin-based neoadjuvant or adjuvant chemotherapy completed \<12 months.
* Malabsorption syndrome or uncontrolled inflammatory gastrointestinal disease (such as Crohn's disease or ulcerative colitis).
* Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure.
* Uncontrolled infection.
* History of other malignancy. However, subjects who were disease-free for 5 years, or subjects with a history of a completely resected non-melanoma skin cancer or successfully treated in situ carcinoma, were eligible.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Alhambra, California, United States
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Fullerton, California, United States
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La Verne, California, United States
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Northridge, California, United States
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Oxnard, California, United States
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Redondo Beach, California, United States
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Santa Maria, California, United States
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Santa Monica, California, United States
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Terre Haute, Indiana, United States
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Henderson, Nevada, United States
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Ciudad Aut6noma de Buenos Aires, Buenos Aires, Argentina
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Quilmes, Buenos Aires, Argentina
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Neuquén, Neuquén Province, Argentina
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Cipolletti, Río Negro Province, Argentina
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Rosario, Santa Fe Province, Argentina
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Buenos Aires, , Argentina
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La Rioja, , Argentina
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San Miguel de Tucumán, , Argentina
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Santa Fe, , Argentina
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Belo Horizonte, Minas Gerais, Brazil
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Belo Horizonte, Minas Gerais, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Florianópolis, Santa Catarina, Brazil
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Barretos, São Paulo, Brazil
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Jaú, São Paulo, Brazil
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Santo André, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Rio de Janeiro, , Brazil
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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Saint John, New Brunswick, Canada
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London, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Temuco, Región de La Araucania, Chile
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Viña del Mar, Región de Valparaíso, Chile
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Santiago, Región Metro de Santiago, Chile
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Santiago, , Chile
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Hefei, Anhui, China
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Guangzhou, Guangdong, China
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Harbin, Heilongjiang, China
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Nanjing, Jiangsu, China
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Changchun, Jilin, China
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Chengdu, Sichuan, China
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Beijing, , China
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Beijing, , China
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Beijing, , China
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Fuzhou, , China
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Hangzhou, , China
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Qingdao, , China
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Shanghai, , China
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Shanghai, , China
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Tianjin, , China
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Tallinn, , Estonia
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Tartu, , Estonia
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Pokfulam, , Hong Kong
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Tuenmen, , Hong Kong
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Győr, , Hungary
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Kaposvár, , Hungary
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Kecskemét, , Hungary
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Miskolc, , Hungary
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Pécs, , Hungary
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Szeged, , Hungary
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Szolnok, , Hungary
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Coimbatore, , India
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Kochi, , India
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Kochi, , India
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Kolkata, , India
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Kolkata, , India
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Nagpur, , India
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New Delhi, , India
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Pārel, , India
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Pune, , India
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Trivandrum, , India
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Beersheba, , Israel
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Haifa, , Israel
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Jerusalem, , Israel
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Petah Tikva, , Israel
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Ramat Gan, , Israel
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Rehovot, , Israel
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Tel Aviv, , Israel
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Zrifin, , Israel
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L’Aquila, Abruzzo, Italy
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Bari, Apulia, Italy
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Rionero in Vulture (PZ), Basilicate, Italy
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Cesena, Emilia-Romagna, Italy
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Meldola (FC), Emilia-Romagna, Italy
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Modena, Emilia-Romagna, Italy
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Parma, Emilia-Romagna, Italy
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Piacenza, Emilia-Romagna, Italy
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Rimini, Emilia-Romagna, Italy
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Udine, Friuli Venezia Giulia, Italy
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Rome, Lazio, Italy
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Rome, Lazio, Italy
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Rome, Lazio, Italy
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Genoa, Liguria, Italy
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Bergamo, Lombardy, Italy
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Treviglio (BG), Lombardy, Italy
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Pesasro, The Marches, Italy
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Florence, Tuscany, Italy
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Macerata, , Italy
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Acapulco de Juárez, Guerrero, Mexico
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Mexico City, , Mexico
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Oaxaca City, , Mexico
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Amsterdam, , Netherlands
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Leeuwarden, , Netherlands
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Nijmegen, , Netherlands
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Callao, , Peru
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Lima, , Peru
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Lima, , Peru
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Gdansk, , Poland
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Krakow, , Poland
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Olsztyn, , Poland
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Olsztyn, , Poland
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Poznan, , Poland
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Płock, , Poland
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Rybnik, , Poland
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Szczecin, , Poland
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Słupsk, , Poland
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Torun, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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San Juan, , Puerto Rico
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Chelyabinsk, , Russia
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Kirov, , Russia
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Kursk, , Russia
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Moscow, , Russia
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Omsk, , Russia
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Ryazan, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saratov, , Russia
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Sochi, , Russia
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Stavropol, , Russia
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Ufa, , Russia
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Busan, , South Korea
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Daegu, , South Korea
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Hwasun, , South Korea
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Seodaemun-gu, Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Suwon, , South Korea
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Suwon, Kyonggi-do, , South Korea
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Tainan City, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taoyuan, , Taiwan
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Bangkok, , Thailand
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Bangkok, , Thailand
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Hatyai, Songkhla, , Thailand
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Ankara, , Turkey (Türkiye)
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Gaziantep, , Turkey (Türkiye)
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Trabzon, , Turkey (Türkiye)
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Cherkasy, , Ukraine
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Chernivtsi, , Ukraine
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Dnipro, , Ukraine
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Dnipropetrovsk, , Ukraine
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Donetsk, , Ukraine
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Ivano-Frankivsk, , Ukraine
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Kharkiv, , Ukraine
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Kryvyi Rih, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Lutsk, , Ukraine
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Lviv, , Ukraine
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Odesa, , Ukraine
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Plyuty, , Ukraine
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Simferopil, , Ukraine
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Simferopol, , Ukraine
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Sumy, , Ukraine
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Ternopil, , Ukraine
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Uzhhorod, , Ukraine
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Vinnitsia, , Ukraine
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Zaporizhzhia, , Ukraine
Countries
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References
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Chu MP, Hecht JR, Slamon D, Wainberg ZA, Bang YJ, Hoff PM, Sobrero A, Qin S, Afenjar K, Houe V, King K, Koski S, Mulder K, Hiller JP, Scarfe A, Spratlin J, Huang YJ, Khan-Wasti S, Chua N, Sawyer MB. Association of Proton Pump Inhibitors and Capecitabine Efficacy in Advanced Gastroesophageal Cancer: Secondary Analysis of the TRIO-013/LOGiC Randomized Clinical Trial. JAMA Oncol. 2017 Jun 1;3(6):767-773. doi: 10.1001/jamaoncol.2016.3358.
Hecht JR, Bang YJ, Qin SK, Chung HC, Xu JM, Park JO, Jeziorski K, Shparyk Y, Hoff PM, Sobrero A, Salman P, Li J, Protsenko SA, Wainberg ZA, Buyse M, Afenjar K, Houe V, Garcia A, Kaneko T, Huang Y, Khan-Wasti S, Santillana S, Press MF, Slamon D. Lapatinib in Combination With Capecitabine Plus Oxaliplatin in Human Epidermal Growth Factor Receptor 2-Positive Advanced or Metastatic Gastric, Esophageal, or Gastroesophageal Adenocarcinoma: TRIO-013/LOGiC--A Randomized Phase III Trial. J Clin Oncol. 2016 Feb 10;34(5):443-51. doi: 10.1200/JCO.2015.62.6598. Epub 2015 Nov 30.
Other Identifiers
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2007-005725-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLAP016C2301
Identifier Type: OTHER
Identifier Source: secondary_id
EGF110656
Identifier Type: -
Identifier Source: org_study_id
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