Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2007-005725-29 | EudraCT Number | ||
| CLAP016C2301 | Other Identifier | Novartis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This was an international multi-center trial that enrolled patients with locally advanced, unresectable, or metastatic gastric, esophageal, or gastro-esophageal junction cancer whose tumors had amplification of the ErbB2 (HER2) gene. The trial investigated whether lapatinib, when added to the chemotherapy regimen, capecitabine plus oxaliplatin (CapeOx), extended the time to progression and overall survival. Tumor ErbB2 (HER2) status had to be known before trial entry. CapeOx was administered to all patients, and patients were randomly assigned to receive either lapatinib or placebo.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CapeOx plus Lapatinib | Experimental | CapeOx plus Lapatinib |
|
| CapeOx plus Placebo | Placebo Comparator | CapeOx plus Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lapatinib | Drug | 5 pills at 250mg each once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival at the Time of Primary Analysis | Overall Survival was defined as the time from randomization to death from any cause. Participants who had not died were censored at their follow-up visit, either because follow-up had ended or was still ongoing. | From date of randomization till death due to any cause, assessed up the cut-off date for Primary Analysis (24-Sep-2012) (average of 4 years) |
| Overall Survival in All Randomized Participants at the Time of Primary Analysis | Overall Survival was defined as the time from randomization to death from any cause. Participants who had not died were censored at their follow-up visit, either because follow-up had ended or was still ongoing. | From date of randomization till death due to any cause, assessed up the cut-off date for Primary Analysis (24-Sep-2012) (average of 4 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival at the Time of Final Analysis | Overall Survival was defined as the time from randomization to death from any cause. Participants who had not died were censored at their follow-up visit, either because follow-up had ended or was still ongoing. | From date of randomization till death due to any cause, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) |
Not provided
Key inclusion criteria:
Histologically confirmed gastric adenocarcinoma or adenocarcinoma of the esophagus or gastro-esophageal junction.
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:
Key exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Alhambra | California | 91801 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27737436 | Derived | 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. | |
| 26628478 |
Not provided
Not provided
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Not provided
Not provided
Not provided
Not provided
Participants were randomized into one of two treatment arms: CapeOx plus lapatinib (the experimental arm) or CapeOx plus placebo (the control arm) using a 1:1 randomization.
This study was conducted at 186 centers in 21 countries in North America (Canada and US), Asia (China, Hong Kong, Korea and Taiwan), and Rest of World (ROW) (Argentina, Brazil, Chile, Estonia, Hungary, India, Israel, Italy, Mexico, Netherlands, Peru, Poland, Russian Federation, Turkey, and Ukraine).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | CapeOx Plus Lapatinib | Participants received a combination therapy consisting of:
After discontinuing oxaliplatin, capecitabine and lapatinib were continued until disease progression, unacceptable toxicity, or withdrawal of consent. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | 5 pills once daily |
|
| Capecitabine | Drug | 1700mg/m2/day in two daily doses |
|
| Oxaliplatin | Drug | 130mg/m2 on day 1 |
|
| Progression Free Survival (PFS) | Progression-Free Survival (PFS) was defined as the time from randomization to the earliest occurrence of disease progression or death from any cause. Per RECIST v1.0, progression was defined as at least a 20% increase in the sum of diameters of target lesions from the smallest recorded sum or the appearance of one or more new lesions. Participants with symptomatic progression, even without radiological confirmation, were also counted. Those who had neither progressed nor died were censored at their follow-up visit, either because follow-up had ended or was ongoing. Participants who received non-study anti-cancer therapies before progression were also censored. | From date of randomization till the earliest date of disease progression or death due to any cause, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) |
| Percentage of Participants With a Confirmed Complete Response (CR) or a Partial Response (PR) | A participant was considered a responder if they had achieved either a complete response (CR), defined as the disappearance of all target and non-target lesions, or a partial response (PR), defined as at least a 30% reduction in the sum of the longest diameters of target lesions from baseline, as assessed by the investigator and confirmed by radiographic imaging within four weeks of the initial observation. | From date of randomization till the date of the first documented response of CR or PR, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) |
| Percentage of Participants With Clinical Benefit (CB) | Clinical Benefit (CB) was defined as evidence of a complete response (CR), partial response (PR), or stable disease (SD). CR referred to the disappearance of all target and non-target lesions, PR to at least a 30% reduction in the sum of the longest diameters of target lesions from baseline, and SD to neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progression, based on the smallest sum of diameters recorded since treatment initiation. All assessments were made by the investigator. | From date of randomization till date of disease progression (PD) or death due to any cause, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) |
| Time to Response (TTR) | Time to Response (TTR) was defined as the duration from randomization to the first documented evidence of either a complete response (CR) (the disappearance of all target and non-target lesions) or a partial response (PR) (at least a 30% reduction in the sum of the longest diameters of target lesions from baseline) as assessed by the investigator. | From date of randomization till the first documented evidence of confirmed CR or PR, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) |
| Duration of Response (DOR) | Duration of Response (DOR) was defined as the time from the first documented evidence of a complete response (CR) or partial response (PR) until the first recorded sign of disease progression or death from any cause. According to RECIST, progression was defined as at least a 20% increase in the sum of diameters of target lesions from the smallest recorded sum or the appearance of one or more new lesions. Participants who had neither progressed nor died were censored at their follow-up visit, either because follow-up had ended or was ongoing. Those who received non-study anti-cancer therapies before progression were also censored. | From the time of the first documented evidence of a confirmed CR or PR until the earliest date of disease progression or death due to any cause, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) |
| Percentage of Participants With Any On-therapy Adverse Event (AE) and Serious Adverse Event (SAE) | An Adverse Event (AE) was defined as any untoward medical occurrence in a participant that was temporally associated with the use of a medicinal product, regardless of its causal relationship. This included any unfavorable or unintended sign (such as abnormal lab findings), symptom, or disease, whether new or worsened. A Serious Adverse Event (SAE) was defined as any such occurrence that, at any dose, resulted in death, was life-threatening, required hospitalization or its prolongation, caused disability or incapacity, led to a congenital anomaly or birth defect, or was a potential case of drug-induced liver injury. | From the first dose of study medication until 30 days after the last dose, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) |
| Percentage of Participants With On-therapy Adverse Event (AE) by Maximum Grade | An Adverse Event (AE) was defined as any untoward medical occurrence in a participant that was temporally associated with the use of a medicinal product, regardless of its relationship to the product. This included any unfavorable or unintended sign (such as abnormal lab results), symptom, or disease, whether new or worsened. The severity of AEs was graded according to NCI CTCAE version 3.0: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (life-threatening), and Grade 5 (death related to toxicity). | From the first dose of study medication until 30 days after the last dose, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) |
| Percentage of Participants With On-therapy Serious Adverse Event (SAE) by Maximum Grade | A Serious Adverse Event (SAE) was defined as any such occurrence that resulted in death, was life-threatening, required hospitalization or its prolongation, caused disability or incapacity, led to a congenital anomaly or birth defect, or was a potential case of drug-induced liver injury. The severity of SAEs was graded according to NCI CTCAE version 3.0: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (life-threatening), and Grade 5 (death related to toxicity). | From the first dose of study medication until 30 days after the last dose, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) |
| Mean Change From Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QOL) Questionnaire Core 30 (QLQ-C30) Domain Scores | The EORTC QLQ-C30 is a comprehensive questionnaire developed for assessing the quality of life of cancer patients across different aspects including function scales namely physical, role, cognitive, emotional and social; symptom scales such as fatigue, pain, nausea and vomiting; and a global scale pronouncing overall health status. Its scoring method involves a 4-point Likert scale (ranging from 1 'Not at all' to 4 'Very Much'). Domain scores are calculated by averaging the items within the respective domain and then linearly transforming the score to fit within a 0-100 scale to finalize the scores. In terms of interpretation, a high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems. | From Baseline up to disease progression (PD), assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) |
| Mean Change From Baseline in the EORTC Quality of Life (QOL) Questionnaire of Stomach 22 (QLQ-STO22) Scales/Items Score Scale | The QLQ-STO22 consists of 22 items divided into five subscales: dysphagia, pain, reflux, eating restrictions and anxiety, as well as single items addressing dry mouth, body image, taste, and hair loss. Each item is answered on a 4-point scale, ranging from 1 (not at all) to 4 (very much). Raw scores for each subscale or single item are calculated by averaging the scores of the individual items that make up the scale. These scores are then linearly transformed to range from 0 to 100. In terms of interpretation, a higher score indicates a worse quality of life concerning the specific symptoms assessed. | From Baseline up to disease progression (PD), assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) |
| Mean Change From Baseline in Utility Score (Health Utility Index) in the EuroQoL-5 Dimensions (EQ-5D) Questionnaire | The EQ-5D is a standardized instrument developed by the EuroQoL Group to measure health-related quality of life. It includes a descriptive system covering five dimensions and a Visual Analogue Scale (VAS), often referred to as the Thermometer Score. The Utility Score (Health Utility Index) is derived from the five dimensions of the EQ-5D descriptive system (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has levels indicating severity (e.g., 1 = no problems, 2 = some problems, 3 = extreme problems). These combinations form a health state, which is then converted into a single index value using a country-specific value set. In the UK-based value set, the possible EQ-5D index utility values range from -0.594 to 1.0, where: 1.0 = perfect health, 0 = death and < 0 = health states considered worse than death. | From Baseline up to disease progression (PD), assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) |
| Mean Change From Baseline in Thermometer Score (EQ VAS) in the EuroQoL-5 Dimensions (EQ-5D) Questionnaire | The EQ-5D is a standardized instrument developed by the EuroQol Group to measure health-related quality of life. It includes a descriptive system covering five dimensions and a Visual Analogue Scale (VAS), often referred to as the Thermometer Score. The Thermometer Score is a self-rated health score using a vertical visual analogue scale , where respondents rate their overall health on a scale from 0 (worst imaginable health) to 100 (best imaginable health). | From Baseline up to disease progression (PD), assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) |
| Percentage of Participants With Worst-case On-therapy Chemistry Toxicities | The severity of chemistry parameters was graded according to NCI CTCAE version 3.0: Grade 0 (No adverse event or within normal limits), Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (life-threatening). Chemistry data included: Alanine aminotransferase (ALT), Albumin, Alkaline phosphatases (ALP), Aspartate aminotransferase (AST), Calcium (hypercalcemia), Calcium (hypocalcemia), Creatine Kinase (CK), Creatine, Glucose (hyperglycemia), Glucose (hypoglycemia), Magnesium (hypermagnesemia), Magnesium (hypomagnesemia), Potassium (hyperkalemia), Potassium (hypokalemia), Sodium (hypernatremia), Sodium (hyponatremia) and Total Bilirubin. | From the first dose of study medication until 30 days after the last dose, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) |
| Percentage of Participants With Worst-case On-therapy Hematologic Toxicities | The severity of hematologic parameters was graded according to NCI CTCAE version 3.0: Grade 0 (No adverse event or within normal limits), Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (life-threatening). Hematology data included: Hemoglobin, Platelet count, Total Neutrophils (Total ANC - Total Absolute Neutrophil Count) and White Blood Cell count. | From the first dose of study medication until 30 days after the last dose, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) |
| Fullerton |
| California |
| 92835 |
| United States |
| Novartis Investigative Site | La Verne | California | 91750 | United States |
| Novartis Investigative Site | Northridge | California | 91328 | United States |
| Novartis Investigative Site | Oxnard | California | 93030 | United States |
| Novartis Investigative Site | Redondo Beach | California | 90277 | United States |
| Novartis Investigative Site | Santa Maria | California | 93454 | United States |
| Novartis Investigative Site | Santa Monica | California | 90404 | United States |
| Novartis Investigative Site | Terre Haute | Indiana | 47802 | United States |
| Novartis Investigative Site | Henderson | Nevada | 89052 | United States |
| Novartis Investigative Site | Ciudad Aut6noma de Buenos Aires | Buenos Aires | C1050AAK | Argentina |
| Novartis Investigative Site | Quilmes | Buenos Aires | 1878 | Argentina |
| Novartis Investigative Site | Neuquén | Neuquén Province | Q8300HDH | Argentina |
| Novartis Investigative Site | Cipolletti | Río Negro Province | R8324EMB | Argentina |
| Novartis Investigative Site | Rosario | Santa Fe Province | S2000KZE | Argentina |
| Novartis Investigative Site | Buenos Aires | 1264 | Argentina |
| Novartis Investigative Site | La Rioja | F5300COE | Argentina |
| Novartis Investigative Site | San Miguel de Tucumán | 4000 | Argentina |
| Novartis Investigative Site | Santa Fe | 3000 | Argentina |
| Novartis Investigative Site | Belo Horizonte | Minas Gerais | 30110-090 | Brazil |
| Novartis Investigative Site | Belo Horizonte | Minas Gerais | 30150-281 | Brazil |
| Novartis Investigative Site | Porto Alegre | Rio Grande do Sul | 90035-001 | Brazil |
| Novartis Investigative Site | Porto Alegre | Rio Grande do Sul | 90050-170 | Brazil |
| Novartis Investigative Site | Florianópolis | Santa Catarina | 88034-000 | Brazil |
| Novartis Investigative Site | Barretos | São Paulo | 14784-400 | Brazil |
| Novartis Investigative Site | Jaú | São Paulo | 17210-120 | Brazil |
| Novartis Investigative Site | Santo André | São Paulo | 09060-650 | Brazil |
| Novartis Investigative Site | São Paulo | São Paulo | 01221-020 | Brazil |
| Novartis Investigative Site | São Paulo | São Paulo | 01246-000 | Brazil |
| Novartis Investigative Site | São Paulo | São Paulo | 01308-500 | Brazil |
| Novartis Investigative Site | Rio de Janeiro | 20230-130 | Brazil |
| Novartis Investigative Site | Edmonton | Alberta | T6G 1Z2 | Canada |
| Novartis Investigative Site | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Novartis Investigative Site | Saint John | New Brunswick | E2L 4L2 | Canada |
| Novartis Investigative Site | London | Ontario | N6A 4L6 | Canada |
| Novartis Investigative Site | Toronto | Ontario | M4C 3E7 | Canada |
| Novartis Investigative Site | Toronto | Ontario | M5B 1W8 | Canada |
| Novartis Investigative Site | Toronto | Ontario | M5G 2M9 | Canada |
| Novartis Investigative Site | Montreal | Quebec | H2W 1S6 | Canada |
| Novartis Investigative Site | Montreal | Quebec | H3G 1A4 | Canada |
| Novartis Investigative Site | Temuco | Región de La Araucania | 481-0469 | Chile |
| Novartis Investigative Site | Santiago | Región Metro de Santiago | 7500921 | Chile |
| Novartis Investigative Site | Viña del Mar | Valparaiso | 254-0364 | Chile |
| Novartis Investigative Site | Santiago | 7510032 | Chile |
| Novartis Investigative Site | Hefei | Anhui | 230022 | China |
| Novartis Investigative Site | Guangzhou | Guangdong | 510515 | China |
| Novartis Investigative Site | Harbin | Heilongjiang | 150040 | China |
| Novartis Investigative Site | Nanjing | Jiangsu | 210002 | China |
| Novartis Investigative Site | Changchun | Jilin | 130012 | China |
| Novartis Investigative Site | Chengdu | Sichuan | 610041 | China |
| Novartis Investigative Site | Beijing | 100021 | China |
| Novartis Investigative Site | Beijing | 100071 | China |
| Novartis Investigative Site | Beijing | 100853 | China |
| Novartis Investigative Site | Fuzhou | 350025 | China |
| Novartis Investigative Site | Hangzhou | 310016 | China |
| Novartis Investigative Site | Qingdao | 266061 | China |
| Novartis Investigative Site | Shanghai | 200032 | China |
| Novartis Investigative Site | Shanghai | 200080 | China |
| Novartis Investigative Site | Tianjin | 300060 | China |
| Novartis Investigative Site | Tallinn | 13419 | Estonia |
| Novartis Investigative Site | Tartu | 51014 | Estonia |
| Novartis Investigative Site | Pokfulam | Hong Kong |
| Novartis Investigative Site | Tuenmen | Hong Kong |
| Novartis Investigative Site | Győr | H-9024 | Hungary |
| Novartis Investigative Site | Kaposvár | 7400 | Hungary |
| Novartis Investigative Site | Kecskemét | 6000 | Hungary |
| Novartis Investigative Site | Miskolc | 3526 | Hungary |
| Novartis Investigative Site | Pécs | 7624 | Hungary |
| Novartis Investigative Site | Szeged | 6720 | Hungary |
| Novartis Investigative Site | Szolnok | 5004 | Hungary |
| Novartis Investigative Site | Coimbatore | 641037 | India |
| Novartis Investigative Site | Kochi | 682041 | India |
| Novartis Investigative Site | Kochi | India |
| Novartis Investigative Site | Kolkata | 700 053 | India |
| Novartis Investigative Site | Kolkata | 700026 | India |
| Novartis Investigative Site | Nagpur | 440010 | India |
| Novartis Investigative Site | New Delhi | India |
| Novartis Investigative Site | Pārel | 400012 | India |
| Novartis Investigative Site | Pune | 411001 | India |
| Novartis Investigative Site | Trivandrum | 695011 | India |
| Novartis Investigative Site | Beersheba | 84101 | Israel |
| Novartis Investigative Site | Haifa | 31096 | Israel |
| Novartis Investigative Site | Jerusalem | 91031 | Israel |
| Novartis Investigative Site | Petah Tikva | 49100 | Israel |
| Novartis Investigative Site | Ramat Gan | 52621 | Israel |
| Novartis Investigative Site | Rehovot | 76100 | Israel |
| Novartis Investigative Site | Tel Aviv | 64239 | Israel |
| Novartis Investigative Site | Zrifin | 70300 | Israel |
| Novartis Investigative Site | L’Aquila | Abruzzo | 67100 | Italy |
| Novartis Investigative Site | Bari | Apulia | 70124 | Italy |
| Novartis Investigative Site | Rionero in Vulture (PZ) | Basilicate | 85028 | Italy |
| Novartis Investigative Site | Cesena | Emilia-Romagna | 47023 | Italy |
| Novartis Investigative Site | Meldola (FC) | Emilia-Romagna | 47014 | Italy |
| Novartis Investigative Site | Modena | Emilia-Romagna | 41100 | Italy |
| Novartis Investigative Site | Parma | Emilia-Romagna | 43100 | Italy |
| Novartis Investigative Site | Piacenza | Emilia-Romagna | 29100 | Italy |
| Novartis Investigative Site | Rimini | Emilia-Romagna | 47900 | Italy |
| Novartis Investigative Site | Udine | Friuli Venezia Giulia | 33100 | Italy |
| Novartis Investigative Site | Rome | Lazio | 00152 | Italy |
| Novartis Investigative Site | Rome | Lazio | 00161 | Italy |
| Novartis Investigative Site | Rome | Lazio | 00168 | Italy |
| Novartis Investigative Site | Genoa | Liguria | 16132 | Italy |
| Novartis Investigative Site | Bergamo | Lombardy | 24128 | Italy |
| Novartis Investigative Site | Treviglio (BG) | Lombardy | 24047 | Italy |
| Novartis Investigative Site | Pesasro | The Marches | 61122 | Italy |
| Novartis Investigative Site | Florence | Tuscany | 50139 | Italy |
| Novartis Investigative Site | Province of Macerata | Italy |
| Novartis Investigative Site | Acapulco de Juárez | Guerrero | 39670 | Mexico |
| Novartis Investigative Site | Mexico City | CP 14080 | Mexico |
| Novartis Investigative Site | Oaxaca City | 68000 | Mexico |
| Novartis Investigative Site | Amsterdam | 1105 AZ | Netherlands |
| Novartis Investigative Site | Leeuwarden | 8934 AD | Netherlands |
| Novartis Investigative Site | Nijmegen | 6525 GA | Netherlands |
| Novartis Investigative Site | Callao | Callao 2 | Peru |
| Novartis Investigative Site | Lima | Lima 11 | Peru |
| Novartis Investigative Site | Lima | Lima 34 | Peru |
| Novartis Investigative Site | Gdansk | 80-219 | Poland |
| Novartis Investigative Site | Krakow | 31-501 | Poland |
| Novartis Investigative Site | Olsztyn | 10-226 | Poland |
| Novartis Investigative Site | Olsztyn | 10-513 | Poland |
| Novartis Investigative Site | Poznan | 61-866 | Poland |
| Novartis Investigative Site | Płock | 09-400 | Poland |
| Novartis Investigative Site | Rybnik | 44-200 | Poland |
| Novartis Investigative Site | Szczecin | 70-111 | Poland |
| Novartis Investigative Site | Słupsk | 76-200 | Poland |
| Novartis Investigative Site | Torun | 87-100 | Poland |
| Novartis Investigative Site | Warsaw | 02-507 | Poland |
| Novartis Investigative Site | Warsaw | 02-781 | Poland |
| Novartis Investigative Site | San Juan | 00910 | Puerto Rico |
| Novartis Investigative Site | Chelyabinsk | 454087 | Russia |
| Novartis Investigative Site | Kirov | 610021 | Russia |
| Novartis Investigative Site | Kursk | 305035 | Russia |
| Novartis Investigative Site | Moscow | 115478 | Russia |
| Novartis Investigative Site | Omsk | 644013 | Russia |
| Novartis Investigative Site | Ryazan | 390011 | Russia |
| Novartis Investigative Site | Saint Petersburg | 197758 | Russia |
| Novartis Investigative Site | Saint Petersburg | 198255 | Russia |
| Novartis Investigative Site | Saratov | 410004 | Russia |
| Novartis Investigative Site | Sochi | 354057 | Russia |
| Novartis Investigative Site | Stavropol | 355047 | Russia |
| Novartis Investigative Site | Ufa | 450054 | Russia |
| Novartis Investigative Site | Busan | 602-030 | South Korea |
| Novartis Investigative Site | Daegu | 700-712 | South Korea |
| Novartis Investigative Site | Hwasun | 519-809 | South Korea |
| Novartis Investigative Site | Seodaemun-gu, Seoul | 120-752 | South Korea |
| Novartis Investigative Site | Seoul | 110-744 | South Korea |
| Novartis Investigative Site | Seoul | 135-710 | South Korea |
| Novartis Investigative Site | Seoul | 135-720 | South Korea |
| Novartis Investigative Site | Seoul | 136-705 | South Korea |
| Novartis Investigative Site | Suwon | 442-723 | South Korea |
| Novartis Investigative Site | Suwon, Kyonggi-do | 443-721 | South Korea |
| Novartis Investigative Site | Tainan | 704 | Taiwan |
| Novartis Investigative Site | Taipei | 104 | Taiwan |
| Novartis Investigative Site | Taipei | 112 | Taiwan |
| Novartis Investigative Site | Taoyuan County | 333 | Taiwan |
| Novartis Investigative Site | Bangkok | 10400 | Thailand |
| Novartis Investigative Site | Bangkok | 10700 | Thailand |
| Novartis Investigative Site | Hatyai, Songkhla | 90110 | Thailand |
| Novartis Investigative Site | Ankara | 06500 | Turkey (Türkiye) |
| Novartis Investigative Site | Gaziantep | 27310 | Turkey (Türkiye) |
| Novartis Investigative Site | Trabzon | 61187 | Turkey (Türkiye) |
| Novartis Investigative Site | Cherkasy | 18009 | Ukraine |
| Novartis Investigative Site | Chernivtsi | 58013 | Ukraine |
| Novartis Investigative Site | Dnipro | 49102 | Ukraine |
| Novartis Investigative Site | Dnipropetrovsk | 49100 | Ukraine |
| Novartis Investigative Site | Donetsk | 83092 | Ukraine |
| Novartis Investigative Site | Ivano-Frankivsk | 76018 | Ukraine |
| Novartis Investigative Site | Kharkiv | 61070 | Ukraine |
| Novartis Investigative Site | Kryvyi Rih | 50048 | Ukraine |
| Novartis Investigative Site | Kyiv | 03022 | Ukraine |
| Novartis Investigative Site | Kyiv | 03115 | Ukraine |
| Novartis Investigative Site | Kyiv | 04107 | Ukraine |
| Novartis Investigative Site | Lutsk | 43018 | Ukraine |
| Novartis Investigative Site | Lviv | 79031 | Ukraine |
| Novartis Investigative Site | Odesa | 65055 | Ukraine |
| Novartis Investigative Site | Plyuty | 08720 | Ukraine |
| Novartis Investigative Site | Simferopil | 95023 | Ukraine |
| Novartis Investigative Site | Simferopol | 95023 | Ukraine |
| Novartis Investigative Site | Sumy | 40005 | Ukraine |
| Novartis Investigative Site | Ternopil | 46023 | Ukraine |
| Novartis Investigative Site | Uzhhorod | 88000 | Ukraine |
| Novartis Investigative Site | Vinnitsia | 21029 | Ukraine |
| Novartis Investigative Site | Zaporizhzhia | 69040 | Ukraine |
| Derived |
| 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. |
| FG001 | CapeOx Plus Placebo | Participants received a combination therapy consisting of:
After discontinuing oxaliplatin, capecitabine and the lapatinib placebo were continued until disease progression, unacceptable toxicity, or withdrawal of consent. |
|
| Primary Efficacy (PE) Population | The Primary Efficacy (PE) population included all randomized subjects with centrally confirmed HER2-positive tumors based on FISH assessment. This population was used to analyze efficacy and health outcomes at the time of the primary CSR. |
|
| Safety Population | The Safety population included all randomized subjects who had received at least one dose of study medication. Analyses were based on the actual treatment received, and this population was used for the final safety analysis. |
|
| Ongoing: On Study Treatment | Due to local regulations in China (HGRAC), data collection at all sites in China was immediately stopped as of 01-Jul-2016. No data from Chinese subjects was transferred or processed thereafter. Consequently, this subject was marked as "ongoing" in the database. |
|
| Ongoing: In Follow Up | Due to local regulations in China, data from Chinese subjects dated from 01-Jul-2016 onward was excluded. As noted in the primary CSR, the subject had been withdrawn from the study on 05 Apr 2011 due to being lost to follow-up, and overall survival was unknown. However, a data transition issue from the previous database (TRIO) led to the subject being incorrectly reported as "ongoing". |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CapeOx Plus Lapatinib | Participants received a combination therapy consisting of:
After discontinuing oxaliplatin, capecitabine and lapatinib were continued until disease progression, unacceptable toxicity, or withdrawal of consent. |
| BG001 | CapeOx Plus Placebo | Participants received a combination therapy consisting of:
After discontinuing oxaliplatin, capecitabine and the lapatinib placebo were continued until disease progression, unacceptable toxicity, or withdrawal of consent. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Survival at the Time of Primary Analysis | Overall Survival was defined as the time from randomization to death from any cause. Participants who had not died were censored at their follow-up visit, either because follow-up had ended or was still ongoing. | Primary Efficacy (PE) population | Posted | Median | 95% Confidence Interval | Months | From date of randomization till death due to any cause, assessed up the cut-off date for Primary Analysis (24-Sep-2012) (average of 4 years) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Overall Survival in All Randomized Participants at the Time of Primary Analysis | Overall Survival was defined as the time from randomization to death from any cause. Participants who had not died were censored at their follow-up visit, either because follow-up had ended or was still ongoing. | Intent-to-Treat (ITT) Population | Posted | Median | 95% Confidence Interval | Months | From date of randomization till death due to any cause, assessed up the cut-off date for Primary Analysis (24-Sep-2012) (average of 4 years) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival at the Time of Final Analysis | Overall Survival was defined as the time from randomization to death from any cause. Participants who had not died were censored at their follow-up visit, either because follow-up had ended or was still ongoing. | Primary Efficacy (PE) population | Posted | Median | 95% Confidence Interval | Months | From date of randomization till death due to any cause, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | Progression-Free Survival (PFS) was defined as the time from randomization to the earliest occurrence of disease progression or death from any cause. Per RECIST v1.0, progression was defined as at least a 20% increase in the sum of diameters of target lesions from the smallest recorded sum or the appearance of one or more new lesions. Participants with symptomatic progression, even without radiological confirmation, were also counted. Those who had neither progressed nor died were censored at their follow-up visit, either because follow-up had ended or was ongoing. Participants who received non-study anti-cancer therapies before progression were also censored. | Primary Efficacy (PE) population | Posted | Median | 95% Confidence Interval | Months | From date of randomization till the earliest date of disease progression or death due to any cause, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Confirmed Complete Response (CR) or a Partial Response (PR) | A participant was considered a responder if they had achieved either a complete response (CR), defined as the disappearance of all target and non-target lesions, or a partial response (PR), defined as at least a 30% reduction in the sum of the longest diameters of target lesions from baseline, as assessed by the investigator and confirmed by radiographic imaging within four weeks of the initial observation. | Primary Efficacy (PE) population | Posted | Count of Participants | Participants | From date of randomization till the date of the first documented response of CR or PR, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Clinical Benefit (CB) | Clinical Benefit (CB) was defined as evidence of a complete response (CR), partial response (PR), or stable disease (SD). CR referred to the disappearance of all target and non-target lesions, PR to at least a 30% reduction in the sum of the longest diameters of target lesions from baseline, and SD to neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progression, based on the smallest sum of diameters recorded since treatment initiation. All assessments were made by the investigator. | Primary Efficacy (PE) population | Posted | Count of Participants | Participants | From date of randomization till date of disease progression (PD) or death due to any cause, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Response (TTR) | Time to Response (TTR) was defined as the duration from randomization to the first documented evidence of either a complete response (CR) (the disappearance of all target and non-target lesions) or a partial response (PR) (at least a 30% reduction in the sum of the longest diameters of target lesions from baseline) as assessed by the investigator. | Primary Efficacy (PE) population. Only those participants who had a confirmed CR or PR were analyzed for time to response. | Posted | Median | 95% Confidence Interval | Months | From date of randomization till the first documented evidence of confirmed CR or PR, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | Duration of Response (DOR) was defined as the time from the first documented evidence of a complete response (CR) or partial response (PR) until the first recorded sign of disease progression or death from any cause. According to RECIST, progression was defined as at least a 20% increase in the sum of diameters of target lesions from the smallest recorded sum or the appearance of one or more new lesions. Participants who had neither progressed nor died were censored at their follow-up visit, either because follow-up had ended or was ongoing. Those who received non-study anti-cancer therapies before progression were also censored. | Primary Efficacy (PE) population. Only those participants who had a confirmed CR or PR were analyzed for duration of response. | Posted | Median | 95% Confidence Interval | Months | From the time of the first documented evidence of a confirmed CR or PR until the earliest date of disease progression or death due to any cause, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Any On-therapy Adverse Event (AE) and Serious Adverse Event (SAE) | An Adverse Event (AE) was defined as any untoward medical occurrence in a participant that was temporally associated with the use of a medicinal product, regardless of its causal relationship. This included any unfavorable or unintended sign (such as abnormal lab findings), symptom, or disease, whether new or worsened. A Serious Adverse Event (SAE) was defined as any such occurrence that, at any dose, resulted in death, was life-threatening, required hospitalization or its prolongation, caused disability or incapacity, led to a congenital anomaly or birth defect, or was a potential case of drug-induced liver injury. | Safety population | Posted | Count of Participants | Participants | From the first dose of study medication until 30 days after the last dose, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With On-therapy Adverse Event (AE) by Maximum Grade | An Adverse Event (AE) was defined as any untoward medical occurrence in a participant that was temporally associated with the use of a medicinal product, regardless of its relationship to the product. This included any unfavorable or unintended sign (such as abnormal lab results), symptom, or disease, whether new or worsened. The severity of AEs was graded according to NCI CTCAE version 3.0: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (life-threatening), and Grade 5 (death related to toxicity). | Safety population. Only participants with On-therapy AEs | Posted | Count of Participants | Participants | From the first dose of study medication until 30 days after the last dose, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With On-therapy Serious Adverse Event (SAE) by Maximum Grade | A Serious Adverse Event (SAE) was defined as any such occurrence that resulted in death, was life-threatening, required hospitalization or its prolongation, caused disability or incapacity, led to a congenital anomaly or birth defect, or was a potential case of drug-induced liver injury. The severity of SAEs was graded according to NCI CTCAE version 3.0: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (life-threatening), and Grade 5 (death related to toxicity). | Safety population. Only participants with on-therapy Serious Adverse Events (SAEs) | Posted | Count of Participants | Participants | From the first dose of study medication until 30 days after the last dose, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QOL) Questionnaire Core 30 (QLQ-C30) Domain Scores | The EORTC QLQ-C30 is a comprehensive questionnaire developed for assessing the quality of life of cancer patients across different aspects including function scales namely physical, role, cognitive, emotional and social; symptom scales such as fatigue, pain, nausea and vomiting; and a global scale pronouncing overall health status. Its scoring method involves a 4-point Likert scale (ranging from 1 'Not at all' to 4 'Very Much'). Domain scores are calculated by averaging the items within the respective domain and then linearly transforming the score to fit within a 0-100 scale to finalize the scores. In terms of interpretation, a high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems. | Primary Efficacy (PE) population. Only those participants contributing data at the indicated time point were analyzed. | Posted | Mean | Standard Deviation | Scores on a scale | From Baseline up to disease progression (PD), assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in the EORTC Quality of Life (QOL) Questionnaire of Stomach 22 (QLQ-STO22) Scales/Items Score Scale | The QLQ-STO22 consists of 22 items divided into five subscales: dysphagia, pain, reflux, eating restrictions and anxiety, as well as single items addressing dry mouth, body image, taste, and hair loss. Each item is answered on a 4-point scale, ranging from 1 (not at all) to 4 (very much). Raw scores for each subscale or single item are calculated by averaging the scores of the individual items that make up the scale. These scores are then linearly transformed to range from 0 to 100. In terms of interpretation, a higher score indicates a worse quality of life concerning the specific symptoms assessed. | Primary Efficacy (PE) population. Only those participants contributing data at the indicated time point were analyzed. | Posted | Mean | Standard Deviation | Scores on a scale | From Baseline up to disease progression (PD), assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Utility Score (Health Utility Index) in the EuroQoL-5 Dimensions (EQ-5D) Questionnaire | The EQ-5D is a standardized instrument developed by the EuroQoL Group to measure health-related quality of life. It includes a descriptive system covering five dimensions and a Visual Analogue Scale (VAS), often referred to as the Thermometer Score. The Utility Score (Health Utility Index) is derived from the five dimensions of the EQ-5D descriptive system (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has levels indicating severity (e.g., 1 = no problems, 2 = some problems, 3 = extreme problems). These combinations form a health state, which is then converted into a single index value using a country-specific value set. In the UK-based value set, the possible EQ-5D index utility values range from -0.594 to 1.0, where: 1.0 = perfect health, 0 = death and < 0 = health states considered worse than death. | Primary Efficacy (PE) population. Only those participants contributing data at the indicated time point were analyzed. | Posted | Mean | Standard Deviation | Scores on a scale | From Baseline up to disease progression (PD), assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Thermometer Score (EQ VAS) in the EuroQoL-5 Dimensions (EQ-5D) Questionnaire | The EQ-5D is a standardized instrument developed by the EuroQol Group to measure health-related quality of life. It includes a descriptive system covering five dimensions and a Visual Analogue Scale (VAS), often referred to as the Thermometer Score. The Thermometer Score is a self-rated health score using a vertical visual analogue scale , where respondents rate their overall health on a scale from 0 (worst imaginable health) to 100 (best imaginable health). | Primary Efficacy (PE) population. Only those participants contributing data at the indicated time point were analyzed. | Posted | Mean | Standard Deviation | Scores on a scale | From Baseline up to disease progression (PD), assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Worst-case On-therapy Chemistry Toxicities | The severity of chemistry parameters was graded according to NCI CTCAE version 3.0: Grade 0 (No adverse event or within normal limits), Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (life-threatening). Chemistry data included: Alanine aminotransferase (ALT), Albumin, Alkaline phosphatases (ALP), Aspartate aminotransferase (AST), Calcium (hypercalcemia), Calcium (hypocalcemia), Creatine Kinase (CK), Creatine, Glucose (hyperglycemia), Glucose (hypoglycemia), Magnesium (hypermagnesemia), Magnesium (hypomagnesemia), Potassium (hyperkalemia), Potassium (hypokalemia), Sodium (hypernatremia), Sodium (hyponatremia) and Total Bilirubin. | Safety Population. Only those participants contributing data at the indicated time point were analyzed. | Posted | Count of Participants | Participants | From the first dose of study medication until 30 days after the last dose, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Worst-case On-therapy Hematologic Toxicities | The severity of hematologic parameters was graded according to NCI CTCAE version 3.0: Grade 0 (No adverse event or within normal limits), Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (life-threatening). Hematology data included: Hemoglobin, Platelet count, Total Neutrophils (Total ANC - Total Absolute Neutrophil Count) and White Blood Cell count. | Safety Population. Only those participants contributing data at the indicated time point were analyzed. | Posted | Count of Participants | Participants | From the first dose of study medication until 30 days after the last dose, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) |
|
Adverse Events (AEs) were documented from the first administration of the study medication through the end of the Long-Term Follow-up (LTFU) period, covering a duration of up to approximately 16 years. Deaths were recorded from the study initiation through the end of the LTFU period, also assessed up to approximately 16 years. On-treatment period (up to 30 days after last dose) and post-treatment follow-up phase (thereafter) are reported separately.
Deaths in the Long Term Follow-up (LTFU) period were not considered adverse events. The total number at risk in the LTFU included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CapeOx Plus Lapatinib | CapeOx plus Lapatinib combination therapy: Events up to 30 days post-treatment | 42 | 272 | 73 | 270 | 243 | 270 |
| EG001 | CapeOx Plus Placebo | CapeOx plus Placebo combination therapy: Events up to 30 days post-treatment | 40 | 273 | 54 | 267 | 214 | 267 |
| EG002 | CapeOx Plus Lapatinib (Long Term Follow-up (LTFU)) | CapeOx plus Lapatinib combination therapy (Long Term Follow-up (LTFU)): Deaths in the Long Term Follow-up (LTFU) period were not considered adverse events. | 199 | 230 | 0 | 0 | 0 | 0 |
| EG003 | CapeOx Plus Placebo (Long Term Follow-up (LTFU)) | CapeOx plus Placebo combination therapy (Long Term Follow-up (LTFU)): Deaths in the Long Term Follow-up (LTFU) period were not considered adverse events. | 189 | 233 | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Enterocutaneous fistula | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Gastric dilatation | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Gastrointestinal obstruction | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Ileus spastic | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Mesenteric vein thrombosis | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Obstruction gastric | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Condition aggravated | General disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Drowning | General disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Contrast media reaction | Immune system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Large intestine infection | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Lung abscess | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Face injury | Injury, poisoning and procedural complications | MedDRA (27.1) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (27.1) | Systematic Assessment |
| |
| Spinal cord injury thoracic | Injury, poisoning and procedural complications | MedDRA (27.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.1) | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Nervous system disorder | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Speech disorder | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Device occlusion | Product Issues | MedDRA (27.1) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Oliguria | Renal and urinary disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Pharyngeal haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Pulmonary infarction | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA (27.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | + 1 862 778 8300 | Novartis.email@Novartis.com |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D004938 | Esophageal Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077341 | Lapatinib |
| D000069287 | Capecitabine |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Male |
|
| American Indian or Alaska Native |
|
| Central/South Asian Hrtg |
|
| Japanese/East Asian Hrtg/South East Asian Hrtg |
|
| White |
|
|
|
|
|
|
| OG001 | CapeOx Plus Placebo | Participants received a combination therapy consisting of:
After discontinuing oxaliplatin, capecitabine and the lapatinib placebo were continued until disease progression, unacceptable toxicity, or withdrawal of consent. |
|
|
Participants received a combination therapy consisting of:
After discontinuing oxaliplatin, capecitabine and the lapatinib placebo were continued until disease progression, unacceptable toxicity, or withdrawal of consent. |
|
|
| OG001 |
| CapeOx Plus Placebo |
Participants received a combination therapy consisting of:
After discontinuing oxaliplatin, capecitabine and the lapatinib placebo were continued until disease progression, unacceptable toxicity, or withdrawal of consent. |
|
|
Participants received a combination therapy consisting of:
After discontinuing oxaliplatin, capecitabine and the lapatinib placebo were continued until disease progression, unacceptable toxicity, or withdrawal of consent. |
|
|
| OG001 | CapeOx Plus Placebo | Participants received a combination therapy consisting of:
After discontinuing oxaliplatin, capecitabine and the lapatinib placebo were continued until disease progression, unacceptable toxicity, or withdrawal of consent. |
|
|
| OG001 | CapeOx Plus Placebo | Participants received a combination therapy consisting of:
After discontinuing oxaliplatin, capecitabine and the lapatinib placebo were continued until disease progression, unacceptable toxicity, or withdrawal of consent. |
|
|
| OG001 |
| CapeOx Plus Placebo |
Participants received a combination therapy consisting of:
After discontinuing oxaliplatin, capecitabine and the lapatinib placebo were continued until disease progression, unacceptable toxicity, or withdrawal of consent. |
|
|
| OG001 |
| CapeOx Plus Placebo |
Participants received a combination therapy consisting of:
After discontinuing oxaliplatin, capecitabine and the lapatinib placebo were continued until disease progression, unacceptable toxicity, or withdrawal of consent. |
|
|
| OG001 | CapeOx Plus Placebo | Participants received a combination therapy consisting of:
After discontinuing oxaliplatin, capecitabine and the lapatinib placebo were continued until disease progression, unacceptable toxicity, or withdrawal of consent. |
|
|
| OG001 | CapeOx Plus Placebo | Participants received a combination therapy consisting of:
After discontinuing oxaliplatin, capecitabine and the lapatinib placebo were continued until disease progression, unacceptable toxicity, or withdrawal of consent. |
|
|
| OG001 | CapeOx Plus Placebo | Participants received a combination therapy consisting of:
After discontinuing oxaliplatin, capecitabine and the lapatinib placebo were continued until disease progression, unacceptable toxicity, or withdrawal of consent. |
|
|
| OG001 | CapeOx Plus Placebo | Participants received a combination therapy consisting of:
After discontinuing oxaliplatin, capecitabine and the lapatinib placebo were continued until disease progression, unacceptable toxicity, or withdrawal of consent. |
|
|
| OG001 | CapeOx Plus Placebo | Participants received a combination therapy consisting of:
After discontinuing oxaliplatin, capecitabine and the lapatinib placebo were continued until disease progression, unacceptable toxicity, or withdrawal of consent. |
|
|
Participants received a combination therapy consisting of:
After discontinuing oxaliplatin, capecitabine and the lapatinib placebo were continued until disease progression, unacceptable toxicity, or withdrawal of consent. |
|
|
| Grade 1 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 1 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 1 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 1 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 1 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 1 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 1 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 1 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 1 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 1 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 1 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 1 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 1 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 1 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 1 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 1 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 1 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 1 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 1 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|