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

A Phase III Study for ErbB2 Positive Advanced or Metastatic Gastric, Esophageal, or Gastroesophageal Junction Adenocarcinoma Treated With Capecitabine Plus Oxaliplatin With or Without Lapatinib

ClinicalTrials.gov Identifier: NCT00680901

Novartis Reference Number: EGF110656

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

This is an international multi-center trial that will enroll patients with locally advanced, unresectable, or metastatic gastric, esophageal, or gastro-esophageal junction cancer whose tumors have amplification of the ErbB2 (HER2) gene. The trial will investigate whether lapatinib, when added to the chemotherapy regimen, capecitabine plus oxaliplatin (CapeOx), extends the time to progression and overall survival. Tumor ErbB2 (HER2) status must be known before trial entry. CapeOx is administered to all patients, and patients will be randomly assigned to receive either lapatinib or placebo.

Condition 
Neoplasms, Gastrointestinal Tract
Phase 
Phase 3
Overall status 
Active, not recruiting
Enrollment count 
545 participants
Start date 
Jun 04, 2008
Completion date 
Dec 31, 2022
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
Lapatinib
5 pills at 250mg each once daily
Drug
Placebo
5 pills once daily
Drug
Capecitabine
1700mg/m2/day in two daily doses
Drug
Oxaliplatin
130mg/m2 on day 1

Eligibility Criteria

Inclusion Criteria:

Signed informed consent; Histologically confirmed gastric, esophageal, or gastro-esophageal junction adenocarcinoma; disease that is locally advanced (unresectable), metastatic, or locally recurrent disease; Measurable or non-measurable, but radiologically evaluable disease, according to RECIST; ErbB2 (HER2)positive; Age =18 years; ECOG Performance status = 2; Adequate organ function, including adequate hematologic, renal and liver function; Cardiac ejection fraction within institutional range of normal as measured by echocardiogram; Able to swallow and retain oral medications, and/or receive enteral medications via gastrectomy feeding tube; Women and men with potential to have children must be willing to practice acceptable methods of birth control during the study; Prior gastric surgery is permitted if > 3 weeks prior and recovered; Prior chemotherapy for non-gastric malignancy if > than 5 years; Prior neoadjuvant and/or adjuvant chemotherapy for early stage gastric cancer if > 6 months since completion; At least 4 weeks since prior radiotherapy; Prior biologic, hormonal, or immunologic cancer treatment if > 5 years since treatment.

Exclusion Criteria:

Pregnant or lactating females; Known history of active CNS disease; Uncontrolled ascites; Concurrent anti-cancer therapy; Gastric carcinoid, epidermoid, sarcomas, or squamous cell carcinoma; Prior palliative chemotherapy for the treatment of gastric cancer; Prior treatment with oxaliplatin < 12 months; Malabsorption syndrome or uncontrolled inflammatory gastrointestinal disease; Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure; Pre-existing grade = 2 motor or sensory neuropathy; Uncontrolled infection; Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical condition that would interfere with the subject''s safety; Active hepatic or biliary disease; History of other malignancy except if disease-free for 5 years, a history of completely resected non-melanoma skin cancer, or a successfully treated in situ carcinoma; Unresolved or unstable serious toxicity from prior administration of another investigational drug and/or prior cancer treatment; Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent; Known history of DPD deficiency; Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to lapatinib, capecitabine, fluorouracil, platins or their excipients; Use of any investigational drug within 30 days prior randomization; Use of concurrent prohibited medications that would interact with study medications

Study Locations

United States
Novartis Investigative Site
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Alhambra, 91801
California
United States
Novartis Investigative Site
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Fullerton, 92835
California
United States
Novartis Investigative Site
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La Verne, 91750
California
United States
Novartis Investigative Site
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Northridge, 91328
California
United States
Novartis Investigative Site
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Oxnard, 93030
California
United States
Novartis Investigative Site
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Redondo Beach, 90277
California
United States
Novartis Investigative Site
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Santa Maria, 93454
California
United States
Novartis Investigative Site
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Santa Monica, 90404
California
United States
Novartis Investigative Site
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Terre Haute, 47802
Indiana
United States
Novartis Investigative Site
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Henderson, 89052
Nevada
United States
Argentina
Novartis Investigative Site
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Ciudad Aut6noma de Buenos Aires, C1050AAK
Buenos Aires
Argentina
Novartis Investigative Site
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Quilmes, 1878
Buenos Aires
Argentina
Novartis Investigative Site
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Neuquen, Q8300HDH
Neuquén
Argentina
Novartis Investigative Site
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Cipolletti, R8324EMB
Río Negro
Argentina
Novartis Investigative Site
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Rosario, S2000KZE
Santa Fe
Argentina
Novartis Investigative Site
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Ciudad Autonoma de Buenos Aires, 1264
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Argentina
Novartis Investigative Site
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La Rioja, F5300COE
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Argentina
Novartis Investigative Site
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Santa Fe, 3000
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Argentina
Novartis Investigative Site
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Tucuman, 4000
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Argentina
Brazil
Novartis Investigative Site
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Belo Horizonte, 30110-090
Minas Gerais
Brazil
Novartis Investigative Site
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Belo Horizonte, 30150-281
Minas Gerais
Brazil
Novartis Investigative Site
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Porto Alegre, 90035-001
Rio Grande Do Sul
Brazil
Novartis Investigative Site
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Porto Alegre, 90050-170
Rio Grande Do Sul
Brazil
Novartis Investigative Site
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Florianopolis, 88034-000
Santa Catarina
Brazil
Novartis Investigative Site
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Barretos, 14784-400
São Paulo
Brazil
Novartis Investigative Site
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Jau, 17210-120
São Paulo
Brazil
Novartis Investigative Site
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Santo Andre, 09060-650
São Paulo
Brazil
Novartis Investigative Site
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Sao Paulo, 01221-020
São Paulo
Brazil
Novartis Investigative Site
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Sao Paulo, 01246-000
São Paulo
Brazil
Novartis Investigative Site
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Sao Paulo, 01308-500
São Paulo
Brazil
Novartis Investigative Site
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Rio de Janeiro, 20230-130
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Brazil
Canada
Novartis Investigative Site
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Edmonton, T6G 1Z2
Alberta
Canada
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Vancouver, V5Z 4E6
British Columbia
Canada
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Saint John, E2L 4L2
New Brunswick
Canada
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London, N6A 4L6
Ontario
Canada
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Toronto, M4C 3E7
Ontario
Canada
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Toronto, M5B 1W8
Ontario
Canada
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Toronto, M5G 2M9
Ontario
Canada
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Montreal, H2W 1S6
Quebec
Canada
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Montreal, H3G 1A4
Quebec
Canada
Chile
Novartis Investigative Site
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Temuco, 481-0469
Región De La Araucania
Chile
Novartis Investigative Site
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Santiago, 7500921
Región Metro De Santiago
Chile
Novartis Investigative Site
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Vina del Mar, 254-0364
Valparaíso
Chile
Novartis Investigative Site
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Santiago, 7510032
-
Chile
China
Novartis Investigative Site
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Hefei, 230022
Anhui
China
Novartis Investigative Site
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Guangzhou, 510515
Guangdong
China
Novartis Investigative Site
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Ha Er Bin, 150040
Heilongjiang
China
Novartis Investigative Site
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Nanjing, 210002
Jiangsu
China
Novartis Investigative Site
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Changchun, 130012
Jilin
China
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Chengdu, 610041
Sichuan
China
Novartis Investigative Site
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Beijing, 100021
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China
Novartis Investigative Site
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Beijing, 100071
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China
Novartis Investigative Site
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Beijing, 100853
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China
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Fuzhou, 350025
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China
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Hangzhou, 310016
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China
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Qingdao, 266061
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China
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Shanghai, 200032
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China
Novartis Investigative Site
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Shanghai, 200080
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China
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Tianjin, 300060
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China
Estonia
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Tallinn, 13419
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Estonia
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Tartu, 51014
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Estonia
Hong Kong
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Pokfulam,
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Hong Kong
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Tuen Mun,
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Hong Kong
Hungary
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Gyor, H-9024
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Hungary
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Kaposvar, 7400
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Hungary
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Kecskemet, 6000
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Hungary
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Miskolc, 3526
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Hungary
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Pecs, 7624
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Hungary
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Szeged, 6720
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Hungary
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Szolnok, 5004
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Hungary
India
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Calcutta, 700026
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India
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Coimbatore, 641037
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India
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Kochi, 682041
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India
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Kochi,
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India
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Kolkata, 700 053
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India
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Nagpur, 440010
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India
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New Delhi,
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India
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Parel, 400012
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India
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Pune, 411001
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India
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Trivandrum, 695011
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India
Israel
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Beer-Sheva, 84101
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Israel
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Haifa, 31096
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Israel
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Jerusalem, 91031
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Israel
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Petah-Tikva, 49100
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Israel
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Ramat Gan, 52621
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Israel
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Rehovot, 76100
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Israel
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Tel Aviv, 64239
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Israel
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Zrifin, 70300
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Israel
Italy
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L'Aquila, 67100
Abruzzo
Italy
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Rionero In Vulture (PZ), 85028
Basilicata
Italy
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Cesena, 47023
Emilia-Romagna
Italy
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Meldola (FC), 47014
Emilia-Romagna
Italy
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Modena, 41100
Emilia-Romagna
Italy
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Parma, 43100
Emilia-Romagna
Italy
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Piacenza, 29100
Emilia-Romagna
Italy
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Rimini, 47900
Emilia-Romagna
Italy
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Udine, 33100
Friuli-Venezia-Giulia
Italy
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Roma, 00152
Lazio
Italy
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Roma, 00161
Lazio
Italy
Novartis Investigative Site
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Roma, 00168
Lazio
Italy
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Genova, 16132
Liguria
Italy
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Bergamo, 24128
Lombardia
Italy
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Treviglio (BG), 24047
Lombardia
Italy
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Pesasro, 61122
Marche
Italy
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Bari, 70124
Puglia
Italy
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Firenze, 50139
Toscana
Italy
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Macerata,
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Italy
Korea, Republic of
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Busan, 602-030
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Korea, Republic of
Novartis Investigative Site
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Daegu, 700-712
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Korea, Republic of
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Hwasun, 519-809
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Korea, Republic of
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Seodaemun-gu, Seoul, 120-752
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Korea, Republic of
Novartis Investigative Site
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Seoul, 110-744
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Korea, Republic of
Novartis Investigative Site
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Seoul, 135-710
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Korea, Republic of
Novartis Investigative Site
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Seoul, 135-720
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Korea, Republic of
Novartis Investigative Site
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Seoul, 136-705
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Korea, Republic of
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Suwon, Kyonggi-do, 443-721
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Korea, Republic of
Novartis Investigative Site
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Suwon, 442-723
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Korea, Republic of
Mexico
Novartis Investigative Site
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Acapulco, 39670
Guerrero
Mexico
Novartis Investigative Site
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Mexico City, CP 14080
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Mexico
Novartis Investigative Site
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Oaxaca, 68000
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Mexico
Netherlands
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Amsterdam, 1105 AZ
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Netherlands
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Leeuwarden, 8934 AD
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Netherlands
Novartis Investigative Site
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Nijmegen, 6525 GA
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Netherlands
Peru
Novartis Investigative Site
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Callao, Callao 2
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Peru
Novartis Investigative Site
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Lima, Lima 11
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Peru
Novartis Investigative Site
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Lima, Lima 34
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Peru
Poland
Novartis Investigative Site
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Gdansk, 80-219
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Poland
Novartis Investigative Site
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Krakow, 31-501
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Poland
Novartis Investigative Site
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Olsztyn, 10-226
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Poland
Novartis Investigative Site
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Olsztyn, 10-513
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Poland
Novartis Investigative Site
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Plock, 09-400
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Poland
Novartis Investigative Site
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Poznan, 61-866
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Poland
Novartis Investigative Site
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Rybnik, 44-200
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Poland
Novartis Investigative Site
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Slupsk, 76-200
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Poland
Novartis Investigative Site
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Szczecin, 70-111
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Poland
Novartis Investigative Site
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Torun, 87-100
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Poland
Novartis Investigative Site
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Warszawa, 02-507
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Poland
Novartis Investigative Site
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Warszawa, 02-781
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Poland
Puerto Rico
Novartis Investigative Site
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San Juan, 00910
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Puerto Rico
Russian Federation
Novartis Investigative Site
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Chelyabinsk, 454087
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Russian Federation
Novartis Investigative Site
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Kirov, 610021
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Russian Federation
Novartis Investigative Site
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Kursk, 305035
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Russian Federation
Novartis Investigative Site
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Moscow, 115478
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Russian Federation
Novartis Investigative Site
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Omsk, 644013
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Russian Federation
Novartis Investigative Site
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Ryazan, 390011
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Russian Federation
Novartis Investigative Site
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Saratov, 410004
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Russian Federation
Novartis Investigative Site
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Sochi, 354057
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Russian Federation
Novartis Investigative Site
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St. Petersburg, 197758
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Russian Federation
Novartis Investigative Site
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St. Petersburg, 198255
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Russian Federation
Novartis Investigative Site
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Stavropol, 355047
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Russian Federation
Novartis Investigative Site
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Ufa,, 450054
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Russian Federation
Taiwan
Novartis Investigative Site
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Tainan, 704
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Taiwan
Novartis Investigative Site
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Taipei, 104
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Taiwan
Novartis Investigative Site
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Taipei, 112
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Taiwan
Novartis Investigative Site
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Taoyuan County, 333
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Taiwan
Thailand
Novartis Investigative Site
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Bangkok, 10400
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Thailand
Novartis Investigative Site
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Bangkok, 10700
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Thailand
Novartis Investigative Site
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Hatyai, Songkhla, 90110
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Thailand
Turkey
Novartis Investigative Site
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Ankara, 06500
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Turkey
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Gaziantep, 27310
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Turkey
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Trabzon, 61187
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Turkey
Ukraine
Novartis Investigative Site
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Cherkasy, 18009
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Ukraine
Novartis Investigative Site
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Chernivtsi, 58013
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Ukraine
Novartis Investigative Site
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Dnepropetrovsk, 49102
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Ukraine
Novartis Investigative Site
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Dnipropetrovsk, 49100
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Ukraine
Novartis Investigative Site
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Donetsk, 83092
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Ukraine
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Ivano-Frankivsk, 76018
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Ukraine
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Kharkiv, 61070
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Ukraine
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Kryvyi Rih, 50048
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Ukraine
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Kyiv, 03022
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Ukraine
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Kyiv, 03115
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Ukraine
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Kyiv, 04107
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Ukraine
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Lutsk,, 43018
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Ukraine
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Lviv, 79031
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Ukraine
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Odessa, 65055
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Ukraine
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Plyuty, 08720
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Ukraine
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Simferopil, 95023
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Ukraine
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Simferopol, 95023
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Ukraine
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Sumy, 40005
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Ukraine
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Ternopil, 46023
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Ukraine
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Uzhgorod, 88000
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Ukraine
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Vinnitsia, 21029
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Ukraine
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Zaporizhzhia, 69040
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Ukraine

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