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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000660-22 | EudraCT Number |
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This multicenter, randomized, adaptive Phase II/III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) compared to standard taxane (docetaxel or paclitaxel) treatment in participants with human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer. At the start of the trial (stage 1), participants will be randomized with a ratio 2:2:1 to one of three treatment arms: Arm A: trastuzumab emtansine 3.6 milligram per kilogram (mg/kg) per intravenous injection (IV) every 3 weeks; Arm B: trastuzumab emtansine 2.4 mg/kg IV every week; Arm C: standard taxane therapy (docetaxel 75 milligram per meter square [mg/m^2] IV every 3 weeks or paclitaxel 80 mg/m^2 kg IV every week per investigator choice). At the end of the first stage of the study, the dose and schedule of trastuzumab emtansine that will be used in the second stage of the study will be selected by an Independent Data Monitoring Committee (IDMC). The regimen selection analysis will be made after approximately 100 participants across all three study arms have been treated for at least 12 weeks.
Once a trastuzumab emtansine regimen has been selected, Stage I participants who were assigned to the treatment arm which was selected for Stage II of the study and participants who were in the standard taxane group will continue to receive their assigned treatment regimen. Stage I participants who were assigned to the regimen that was not selected for further evaluation will continue to receive their assigned regimen and will continue to be followed for efficacy and safety. In Stage II of the study, additional participants will be recruited and randomized with a ratio 2:1 to either the selected regimen of trastuzumab emtansine or to the standard taxane therapy. Participants will receive study treatment until disease progression, unacceptable toxicity, initiation of another cancer therapy or withdrawal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard taxane therapy | Active Comparator | Docetaxel will be administered at 75 milligram per meter square (mg/m^2) intravenous (IV) on Day 1 of a 21-day cycle, or paclitaxel will administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) according to investigator choice until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue. |
|
| trastuzumab emtansine 2.4 mg | Experimental | Trastuzumab emtansine will be administered on Day 1, 8, and 15 of a 21-day cycle at 2.4 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue. |
|
| trastuzumab emtansine 3.6 mg | Experimental | Trastuzumab emtansine will be administered on Day 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Taxane | Drug | Standard taxane (docetaxel 75 mg/m^2 IV every 3 weeks or paclitaxel 80 mg/m^2) IV once a week according to investigator choice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS)- Phase 3 | Overall survival was defined as the time between the date of randomization and date of death due to any cause. Kaplan-Meier estimates were used for analysis. Participants for whom no death was reported prior to an analysis cutoff (30 June 2015) was censored at the latest date before the cutoff in which they were known to be alive. All data from the standard taxane therapy and trastuzumab emtansine 2.4 mg (selected treatment arm) from phase 2 and phase 3 (Stage 2) are combined into phase 3 data, and thus cumulative data are provided within the results presented for phase 3. The confirmatory analyses are restricted to comparisons between the taxane arm and the selected trastuzumab emtansine arm (2.4 mg). | Date of randomization until death (up to 2 years 3 months) |
| Overall Survival (OS) - Phase 2 (Dose Selection Portion of the Study) | Overall survival was defined as the time between the date of randomization and date of death due to any cause. Kaplan-Meier estimates were used for analysis. Participants for whom no death was reported prior to an analysis cutoff (10 August 2013) was censored at the latest date before the cutoff in which they were known to be alive. | Date of randomization until death (up to 1 year) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Disease Progression or Death According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST v1.1) - Phase 3 | Progressive disease could base on symptom deterioration or was defined as at least a 20 percent (%) increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. Tumor assessment was performed using modified RECIST v1.1. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Blood/Cancer Ctr | Bakersfield | California | 93309 | United States | ||
| Stanford University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30706247 | Derived | Shah MA, Kang YK, Thuss-Patience PC, Ohtsu A, Ajani JA, Van Cutsem E, Hoersch S, Harle-Yge ML, de Haas SL. Biomarker analysis of the GATSBY study of trastuzumab emtansine versus a taxane in previously treated HER2-positive advanced gastric/gastroesophageal junction cancer. Gastric Cancer. 2019 Jul;22(4):803-816. doi: 10.1007/s10120-018-00923-7. Epub 2019 Jan 31. | |
| 28343975 |
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A total of 415 participants were randomized, of these 117 participants in taxane arm, 228 participants in 2.4 milligram per kilogram (mg/kg) trastuzumab emtansine arm, and 70 participants in 3.6 mg/kg trastuzumab emtansine arm received at least one dose of the treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Taxane Therapy | Docetaxel was administered at 75 milligram per meter square (mg/m^2) intravenously (IV) on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| trastuzumab emtansine | Drug | trastuzumab emtansine 3.6 mg/kg IV every 3 weeks |
|
| trastuzumab emtansine | Drug | trastuzumab emtansine 2.4 mg/kg IV once a week |
|
| Date of randomization until disease progression or death, whichever occurred first (assessed at baseline, every 6 weeks up to 2 years 3 months) |
| Progression Free Survival (PFS) According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST v1.1) - Phase 3 | Progression-free survival was defined as the time between the date of randomization and the first date of documented progression or date of death due to any cause, whichever occurred first. Tumor assessment was performed using modified RECIST v1.1. Progressive disease could base on symptom deterioration or was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. Kaplan-Meier estimates were used for analysis. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure. The confirmatory analyses are restricted to comparisons between the taxane arm and the selected trastuzumab emtansine arm (2.4 mg). | Date of randomization until disease progression or death, whichever occurred first (assessed at baseline, every 6 weeks up to 2 years 3 months) |
| Percentage of Participants With Objective Response According to mRECIST v1.1 - Phase 3 | Objective response referred to participants with complete response (CR) or partial response (PR). CR: disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR: greater than or equal to (>=) 30% decrease in sum of the longest diameter (LD) of all target lesions taking as reference the screening sum LD. To be assigned a status of PR or CR, changes in tumor measurements had to be confirmed by repeat assessments that should have been performed no less than 4 weeks after the criteria for response were first met. Longer intervals as determined by the study protocol were also appropriate. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure. | Date of randomization until disease progression or death, whichever occurred first (assessed at baseline, every 6 weeks up to 2 years 3 months) |
| Duration of Objective Response (DOR) - Phase 3 | DOR: time from the date when a clinical response [CR or PR] was first documented to the date of first documented progressive disease (PD) or death. CR:disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR: >= 30% decrease in sum of the LD of all target lesions taking as reference the screening sum LD. PD: could base on symptom deterioration or at least a 20% increase in the sum of diameters of target or non-target lesions and new lesions, taking as reference the smallest sum on study (nadir), including baseline. To be assigned a status of PR or CR, changes in tumor measurements had to be confirmed by repeat assessments that should have been performed no less than 4 weeks after the criteria for response were first met. Longer intervals as determined by the study protocol were also appropriate. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure. | Date of randomization until disease progression or death, whichever occurred first (assessed at baseline, every 6 weeks up to 2 years 3 months) |
| Percentage of Participants With Clinically Significant Improvement in European Organisation for Research and Treatment of Cancer Quality of Life Core Module 30 (EORTC QLQ-C30) Score - Phase 3 | The EORTC QLQ-C30 is a validated, cancer-specific 30-item patient-reported measure, and contains 14 domains to assess the impact of cancer treatment on 5 aspects of participants functioning (physical, role, cognitive, emotional, and social), 9 aspects of disease/treatment-related symptoms (fatigue, nausea and vomiting, pain, dyspnea, insomnia, loss of appetite, constipation, diarrhea) and a global QoL/overall health status scale. Questions used 4 point scale (1 'Not at all' to 4 'Very much'; with the exception of the QoL/health status scale which uses a 7-point scale (1 'very poor' to 7 'Excellent'). Each scale is transformed on a scale of 0-100; a higher score equals (=) a better level of functioning or greater degree of symptoms. Change of greater than or equal to (>=) 10-points has been found to be clinically significant. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure. | Day 1 of each treatment cycle, at the study drug completion visit, and thereafter at follow-up (up to 2 years 3 months) |
| Percentage of Participants With Clinically Significant Improvement in Quality of Life Questionnaire Stomach Cancer Module 22 (QLQ-STO22) Score - Phase 3 | The Quality of Life Questionnaire Stomach Cancer Module 22 (QLQ-STO22) supplements the EORTC QLQ-C30 to assess symptoms and treatment-related side effects commonly reported in participants. There are 22 questions which comprise 5 scales (dysphagia, pain, reflux symptom, dietary restrictions, and anxiety) and 4 single items (dry mouth, hair loss, taste, body image). Most questions use 4-point scale (1 'Not at all' to 4 'Very much'; 1 question was a yes or no answer). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100; higher score=better level of functioning or greater degree of symptoms. Change of >=10 points has been found to be clinically significant. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure. | Day 1 of each treatment cycle, at the study drug completion visit, and thereafter at survival follow-up (up to 2 years 3 months) |
| Percentage of Participants With Advanced Gastric Cancer (AGC) Symptom Progression - Phase 3 | AGC symptomatic progression: a worsening of >=10-points in any 1 of the abdominal discomfort, loss of appetite, weakness and fatigue, upper abdominal pain, change in bowel movement, and/or weight loss scales of the EORTC QLQ-C30 and QLQ-STO22. QLQ-STO22 supplements EORTC QLQ-C30 to assess symptoms and commonly reported treatment-related side effects. There are 22 questions comprise 5 scales (dysphagia, pain, reflux symptom, diet restrictions, anxiety), 4 single items (dry mouth, hair loss, taste, body image), which are related to the symptoms of the disease. Most questions used 4-point scale (1 'Not at all' to 4 'Very much'). All scores and single-items transformed to a scale of 0-100; higher score=better level of functioning or greater degree of symptoms. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure. | Day 1 of each treatment cycle, at the study drug completion visit, and thereafter at survival follow-up (up to 2 years 3 months) |
| Time to Advanced Gastric Cancer (AGC) Symptom Progression - Phase 3 | Time to AGC symptom were defined as the time from randomization to the first documentation of an increase in at least one of the pre-specified abdominal discomfort, loss of appetite, weakness and fatigue, upper abdominal pain, change in bowel movement, and weight loss subscales of the QLQ STO22 and EORTC QLQ-C30. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure. | Day 1 of each treatment cycle, at the study drug completion visit, and thereafter at survival follow-up (up to 2 years 3 months) |
| Maximum Observed Plasma Concentration (Cmax) of Trastuzumab Emtansine (T-DM1) and Total Trastuzumab - Stage 1 | Maximum observed plasma concentration of Trastuzumab Emtansine (T-DM1) and total trastuzumab were reported. Stage 1 consists of all participants recruited before the regimen selection, which was carried out after 12 weeks of randomization. | Day 1 (D1) of Cycle 1 (C1) and C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks) |
| Maximum Observed Plasma Concentration (Cmax) of N2'-Deacetyl-N2'-(3-mercapto-1-oxopropyl)-Maytansine (DM1) - Stage 1 | Maximum observed plasma concentration of DM1 were reported. Stage 1 consists of all participants recruited before the regimen selection decision. Regimen selection analysis was carried out after 12 weeks of randomization. | C1D1 and C1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks) |
| Maximum Observed Plasma Concentration (Cmax) of Trastuzumab Emtansine (T-DM1) and Total Trastuzumab - Stage 2 | Stage 2 consists of all participants recruited after the regimen selection decision up to primary data cut-off date 30-June-2015. | C1D1; C4D1 |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf] - Stage 1 | AUCinf= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf). Stage 1 consists of all participants recruited before the regimen selection decision. Regimen selection analysis was carried out after 12 weeks of randomization. | D1C1 and D1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks) |
| Plasma Decay Half-Life (t1/2) - Stage 1 | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Stage 1 consists of all participants recruited before the regimen selection decision. Regimen selection analysis was carried out after 12 weeks of randomization. | D1C1 and D1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks) |
| Volume of Distribution at Steady State (Vss) - Stage 1 | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. Stage 1 consists of all participants recruited before the regimen selection decision. Regimen selection analysis was carried out after 12 weeks of randomization. | D1C1 and D1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks) |
| Systemic Clearance (CL) - Stage 1 | CL is a quantitative measure of the rate at which a drug substance is removed from the body. Stage 1 consists of all participants recruited before the regimen selection decision. Regimen selection analysis was carried out after 12 weeks of randomization. | D1C1 and D1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks) |
| Stanford |
| California |
| 94305-5151 |
| United States |
| Yale Cancer Center | New Haven | Connecticut | 06520 | United States |
| University of Kansas; Medical Center & Medical pavilion | Westwood | Kansas | 66205 | United States |
| Norton Healthcare Inc. | Louisville | Kentucky | 40202 | United States |
| Massachusetts General Hospital. | Boston | Massachusetts | 02114 | United States |
| Dana Farber Can Ins | Boston | Massachusetts | 02215 | United States |
| Weill Cornell Medical College | New York | New York | 10065 | United States |
| Vanderbilt | Nashville | Tennessee | 37232 | United States |
| University of Texas M.D. Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Fundación Investigar | Buenos Aires | 1025 | Argentina |
| Hospital de Gastroenterologia Dr. Bonorino Udaondo ; Servicio de Oncología | Buenos Aires | C1264AAA | Argentina |
| Instituto de Oncología de Rosario | Rosario | S2000KZE | Argentina |
| UZ Leuven Gasthuisberg | Leuven | 3000 | Belgium |
| Instituto Nacional de Cancer - INCa; Oncologia | Rio de Janeiro | Rio de Janeiro | 20560-120 | Brazil |
| Clinica de Oncologia de Porto Alegre - CliniOnco | Porto Alegre | Rio Grande do Sul | 90430-090 | Brazil |
| Hospital Sao Lucas - PUCRS | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Hospital de Cancer de Barretos | Barretos | São Paulo | 14784-400 | Brazil |
| Hospital Amaral Carvalho | Jaú | São Paulo | 17210-080 | Brazil |
| Instituto do Cancer do Estado de Sao Paulo - ICESP | São Paulo | São Paulo | 01246-000 | Brazil |
| Instituto de Oncologia de Sorocaba - CEPOS | Sorocaba | São Paulo | 18030-245 | Brazil |
| BCCA-Vancouver Cancer Centre | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Brampton Memorial Hospital, William Osler Health Center | Brampton | Ontario | L6R 3J7 | Canada |
| Toronto East General Hospital; Haematology/Oncology | Toronto | Ontario | M4C 3E7 | Canada |
| St. Michael'S Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA) | Beijing | 100071 | China |
| Beijing Cancer Hospital | Beijing | 100142 | China |
| Jilin Cancer Hospital | Changchun | 130012 | China |
| the First Hospital of Jilin University | Changchun | 130021 | China |
| Changzhou First People's Hospital | Changzhou | 213003 | China |
| Third Affiliated Hospital of Third Military Medical University | Chongqing | 400042 | China |
| Fujian Cancer Hospital | Fuzhou | 350014 | China |
| Sun Yet-sen University Cancer Center | Guangzhou | 510060 | China |
| Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University | Hangzhou | 310016 | China |
| Harbin Medical University Cancer Hospital | Harbin | 150081 | China |
| Jiangsu Cancer Hospital | Nanjing | 210009 | China |
| The 81st Hospital of P.L.A. | Nanjing | China |
| Affiliated Hospital of Nantong University | Nantong | 226001 | China |
| Fudan University Shanghai Cancer Center | Shanghai | 200032 | China |
| Zhongshan Hospital Fudan University | Shanghai | 200032 | China |
| Shanghai First People's Hospital | Shanghai | 200080 | China |
| General Hospital of Shenyang Military Command of PLA | Shenyang | 110016 | China |
| Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center | Wuhan | 430023 | China |
| First Affiliated Hospital of Medical College of Xi'an Jiaotong University | Xi'an | 710061 | China |
| The Affiliated Hospital of Xuzhou Medical College | Xuzhou | 221004 | China |
| Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology | Hradec Králové | 500 05 | Czechia |
| Fakultni nemocnice Olomouc; Onkologicka klinika | Olomouc | 779 00 | Czechia |
| Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika | Prague | 128 08 | Czechia |
| Fakultní Nemocnice V Motole; Radioterapeuticko-Onkologicke Oddeleni | Prague | 150 06 | Czechia |
| Tampere University Hospital; Dept of Oncology | Tampere | 33520 | Finland |
| Hopital Augustin Morvan; Federation De Cancerologie | Brest | 29200 | France |
| Hopital Beaujon; Gastro Enterologie 1 | Clichy | 92118 | France |
| Centre Val Aurelle Paul Lamarque; Medecine A1 A2 | Montpellier | 34298 | France |
| Hopital Saint Antoine; Hepatologie-Gastr-Enterologie | Paris | 75571 | France |
| Hop Europeen Georges Pompidou; Gastro Enterologie | Paris | 75908 | France |
| Hopital Robert Debre; Gastro Enterologie | Reims | 51092 | France |
| Hopital Purpan; Unite Onco Digestive | Toulouse | 31059 | France |
| Charité-Universitätsm. Berlin; Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunolo. | Berlin | 10117 | Germany |
| Universitätsklinikum Köln | Cologne | 50937 | Germany |
| Universitätsklinikum "Carl Gustav Carus"; Med. Klinik & Poliklinik I, Arbeitsgr. intern. Onkologie | Dresden | 01307 | Germany |
| Facharztzentrum Eppendorf, Studien GbR | Hamburg | 20249 | Germany |
| Tagesklinik Landshut; Hämatologie/Onkologie | Landshut | 84028 | Germany |
| Onkologische Gemeinschaftspraxis | Magdeburg | 39104 | Germany |
| Centro Oncológico Sixtino / Centro Oncológico SA | Guatemala City | 01010 | Guatemala |
| Grupo Angeles | Guatemala City | 01015 | Guatemala |
| Fovarosi Szent Laszlo Korhaz-Rendelointezet; Onkologiai Osztaly X | Budapest | 1097 | Hungary |
| Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika | Szeged | 6720 | Hungary |
| Hetenyi Geza County Hospital; Onkologiai Kozpont | Szolnok | 5004 | Hungary |
| Zala Megyei Kórház, Külsö Kórház, Pózva; Onkológiai Osztály | Zalaegerszeg | 8900 | Hungary |
| Campus Universitario S.Venuta; Centro Oncologico T.Campanella | Catanzaro | Calabria | 88100 | Italy |
| AZ.Osp S. Orsola - Malpighi-Reparto di Oncologia Medica | Bologna | Emilia-Romagna | 40138 | Italy |
| A.O. Città della Salute e della Scienza - Presidio Molinette; divisione oncologia medica | Turin | Piedmont | 10126 | Italy |
| Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1 | Florence | Tuscany | 50139 | Italy |
| A.O. Universitaria Pisana; Oncologia | Pisa | Tuscany | 56100 | Italy |
| Aichi Cancer Center Hospital; Clinical Oncology | Aichi | 464-8681 | Japan |
| Chiba Cancer Center; Gastroenterology | Chiba | 260-8717 | Japan |
| National Cancer Center Hospital East; Gastroenterology | Chiba | 277-8577 | Japan |
| National Hospital Organization Shikoku Cancer Center; Gastroenterology | Ehime | 791-0280 | Japan |
| Hokkaido University Hospital：Gastroenterology | Hokkaido | 060-8648 | Japan |
| Hyogo College Of Medicine; Upper Gastroenterology | Hyōgo | 663-8501 | Japan |
| Hyogo Cancer Center; Gastroenterology | Hyōgo | 673-8558 | Japan |
| Ibaraki Prefectural Central Hospital; Gastroenterology | Ibaraki | 309-1793 | Japan |
| Tohoku Uni Hospital; Clinical Oncology | Miyagi | 980-8574 | Japan |
| Osaka University Hospital; Surgery | Osaka | 565-0871 | Japan |
| Kindai University Hospital; Medical Oncology | Osaka | 589-8511 | Japan |
| Saitama Cancer Center; Gastroenterology | Saitama | 362-0806 | Japan |
| Shizuoka Cancer Center; Gastroenterology | Shizuoka | 411-8777 | Japan |
| Shizuoka General Hospital; Clinical Oncology | Shizuoka | 420-8527 | Japan |
| Tochigi Cancer Center; Medical Oncology | Tochigi | 320-0834 | Japan |
| National Cancer Center Hospital; Gastrointestinal Oncology | Tokyo | 104-0045 | Japan |
| Toranomon Hospital; Medical Oncology | Tokyo | 105-8470 | Japan |
| Tokyo Metropolitan Komagome Hospital; Chemotherapy | Tokyo | 113-8677 | Japan |
| The Cancer Institute Hospital, JFCR; Gastroenterology | Tokyo | 135-8550 | Japan |
| Hospital Wanita dan Kanak-Kanak Sabah | Sabah | Sabah | 88996 | Malaysia |
| University Malaya Medical Centre; Clinical Oncology Unit, | Kuala Lumpur | 59100 | Malaysia |
| Centenario Hospital Miguel Hidalgo | Aguascalientes | 20230 | Mexico |
| Centro Estatal De Cancerologia De Chihuahua; Servicio De Hematologia Banco De Sangre | Chihuahua City | 31000 | Mexico |
| Hospital General de México; Unidad de Oncologia | Mexico City | 06726 | Mexico |
| Centro Hemato Oncologico Paitilla | Panama City | 083200752 | Panama |
| Hospital Nacional Almanzor Aguinaga Asenjo; Unidad De Investigacion Del Servicio De Oncologia Medica | Chiclayo | CIX | Peru |
| Hospital Nacional Adolfo Guevara Velasco | Cusco | 08006 | Peru |
| Hospital Nacional Edgardo Rebagliati Martins | Jesus Maria | Lima 11 | Peru |
| Instituto Nacional de Enfermedades Neoplasicas | Lima | 34 | Peru |
| Perpetual Succour Hospital | Cebu | 6000 | Philippines |
| Veterans Memorial Medical Ctr; Cancer Research Centre | Quezon City, Luzon | 1101 | Philippines |
| Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii | Gdansk | 80-952 | Poland |
| Szpital Uniwersytecki w Krakowie | Krakow | 31-501 | Poland |
| Wielkopolskie Centrum Onkologii; im. Marii Skłodowskiej-Curie | Poznan | 61-866 | Poland |
| Wojewódzki Szpital Specjalistyczny Nr 3 | Rybnik | 44-200 | Poland |
| Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie; Klinika Gastroenterologii Onkologicznej | Warsaw | 02-781 | Poland |
| Institutul Clinic Fundeni Bucuresti | Bucharest | 022328 | Romania |
| Spitalul Universitar CF Cluj-Napoca; Sectia Oncologie | Cluj-Napoca | 400015 | Romania |
| Medisprof SRL | Cluj-Napoca | 400058 | Romania |
| Spitalul Clinic Judetean Mures; Oncologie Medicala | Târgu Mureş | 540141 | Romania |
| Arkhangelsk Regional Clinical Oncology Dispensary | Arkhangelsk | 163045 | Russia |
| Ivanovo Regional Oncology Dispensary | Ivanovo | 153040 | Russia |
| Omsk Region Clinical Oncology Dispensary; 1St Sergical Department | Omsk | 644013 | Russia |
| State Budget Institution of Healthcare of Stavropol region Pyatigorsk Oncology Dispensary | Pyatigorsk | 357502 | Russia |
| Tula Regional Oncology Dispensary | Tula | 300053 | Russia |
| National Cancer Centre | Singapore | 169610 | Singapore |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Asan Medical Center; Medical Oncology | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Yonsei University Severance Hospital; Medical Oncology | Seoul | 120-752 | South Korea |
| Korea University Anam Hospital; Oncology Haemotology | Seoul | 136-705 | South Korea |
| Seoul St.Mary's Hospital; Medical Oncology | Seoul | 137-807 | South Korea |
| Hospital Universitario Marques de Valdecilla; Servicio de Oncologia | Santander | Cantabria | 39008 | Spain |
| Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia | Santiago de Compostela | La Coruña | 15706 | Spain |
| Hospital Univ. Central de Asturias; Servicio de Oncologia | Oviedo | Principality of Asturias | 33011 | Spain |
| Hospital Clinic i Provincial; Servicio de Farmacia | Barcelona | 08036 | Spain |
| Hospital General Universitario Gregorio Marañon; Servicio de Oncologia | Madrid | 28007 | Spain |
| Hospital Universitario La Paz; Servicio de Oncologia | Madrid | 28046 | Spain |
| Hospital Universitario Virgen del Rocio; Servicio de Oncologia | Seville | 41013 | Spain |
| Hospital Universitario Miguel Servet; Servicio Oncologia | Zaragoza | 50009 | Spain |
| Kaohsiung Chang Gung Memorial Hospital; Dept of Hem and Onc | Kaohsung | 883 | Taiwan |
| National Taiwan Uni Hospital; Dept of Oncology | Taipei | 100 | Taiwan |
| Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology | Taoyuan | 333 | Taiwan |
| Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department | Erzurum | 25240 | Turkey (Türkiye) |
| Istanbul Bilim University School Of Medicine; Department Of Medical Oncology | Istanbul | 34300 | Turkey (Türkiye) |
| Marmara Uni Faculty of Medicine; Medical Oncology | Istanbul | 34890 | Turkey (Türkiye) |
| Ege Uni Medical Faculty; Oncology Dept | Izmir | 35100 | Turkey (Türkiye) |
| Hacettepe Uni Medical Faculty Hospital; Oncology Dept | Sıhhiye, Ankara | 06100 | Turkey (Türkiye) |
| Velindre Cancer Centre; Oncology Dept | Cardiff | CF14 2TL | United Kingdom |
| The Beatson West of Scotland Cancer Centre; Cancer Clinical Trials Unit | Glasgow | G12 0YN | United Kingdom |
| Royal Marsden Hospital; Dept of Med-Onc | London | SW3 6JJ | United Kingdom |
| Christie Hospital Nhs Trust; Medical Oncology | Manchester | M2O 4BX | United Kingdom |
| Royal Marsden Hospital; Dept of Medical Oncology | Sutton | SM2 5PT | United Kingdom |
| BRISTOL ONCOLOGY CENTRE; CLINICAL TRIALS UNIT; R & D department | Weston-super-Mare | BS23 4TQ | United Kingdom |
| Thuss-Patience PC, Shah MA, Ohtsu A, Van Cutsem E, Ajani JA, Castro H, Mansoor W, Chung HC, Bodoky G, Shitara K, Phillips GDL, van der Horst T, Harle-Yge ML, Althaus BL, Kang YK. Trastuzumab emtansine versus taxane use for previously treated HER2-positive locally advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma (GATSBY): an international randomised, open-label, adaptive, phase 2/3 study. Lancet Oncol. 2017 May;18(5):640-653. doi: 10.1016/S1470-2045(17)30111-0. Epub 2017 Mar 23. |
| FG001 | Trastuzumab Emtansine 2.4 mg | Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue. |
| FG002 | Trastuzumab Emtansine 3.6 mg | Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue. |
| Stage 1 |
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| Stage 2 |
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| COMPLETED |
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| NOT COMPLETED |
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Intent to treat (ITT) analysis population included all randomized participants; participants grouped according to the therapy they were randomized to receive.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Standard Taxane Therapy | Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue. |
| BG001 | Trastuzumab Emtansine 2.4 mg | Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue. |
| BG002 | Trastuzumab Emtansine 3.6 mg | Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Overall Survival (OS)- Phase 3 | Overall survival was defined as the time between the date of randomization and date of death due to any cause. Kaplan-Meier estimates were used for analysis. Participants for whom no death was reported prior to an analysis cutoff (30 June 2015) was censored at the latest date before the cutoff in which they were known to be alive. All data from the standard taxane therapy and trastuzumab emtansine 2.4 mg (selected treatment arm) from phase 2 and phase 3 (Stage 2) are combined into phase 3 data, and thus cumulative data are provided within the results presented for phase 3. The confirmatory analyses are restricted to comparisons between the taxane arm and the selected trastuzumab emtansine arm (2.4 mg). | ITT population included all randomized participants; participants grouped according to the therapy they were randomized to receive. | Posted | Median | 95% Confidence Interval | months | Date of randomization until death (up to 2 years 3 months) |
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| Primary | Overall Survival (OS) - Phase 2 (Dose Selection Portion of the Study) | Overall survival was defined as the time between the date of randomization and date of death due to any cause. Kaplan-Meier estimates were used for analysis. Participants for whom no death was reported prior to an analysis cutoff (10 August 2013) was censored at the latest date before the cutoff in which they were known to be alive. | Analysis population included all participants that had been enrolled in phase 2 (stage 1) up to a clinical cut-off date of 10 August 2013; participants grouped according to the therapy they were randomized to receive. Here, N (number of participants analyzed)=number of evaluable participants during phase 2 up to 10 August 2013. | Posted | Median | 95% Confidence Interval | weeks | Date of randomization until death (up to 1 year) |
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| Secondary | Percentage of Participants With Disease Progression or Death According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST v1.1) - Phase 3 | Progressive disease could base on symptom deterioration or was defined as at least a 20 percent (%) increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. Tumor assessment was performed using modified RECIST v1.1. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure. | ITT population included all randomized participants; participants grouped according to the therapy they were randomized to receive. | Posted | Number | percentage participants | Date of randomization until disease progression or death, whichever occurred first (assessed at baseline, every 6 weeks up to 2 years 3 months) |
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| Secondary | Progression Free Survival (PFS) According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST v1.1) - Phase 3 | Progression-free survival was defined as the time between the date of randomization and the first date of documented progression or date of death due to any cause, whichever occurred first. Tumor assessment was performed using modified RECIST v1.1. Progressive disease could base on symptom deterioration or was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. Kaplan-Meier estimates were used for analysis. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure. The confirmatory analyses are restricted to comparisons between the taxane arm and the selected trastuzumab emtansine arm (2.4 mg). | ITT population included all randomized participants; participants grouped according to the therapy they were randomized to receive. | Posted | Median | 95% Confidence Interval | months | Date of randomization until disease progression or death, whichever occurred first (assessed at baseline, every 6 weeks up to 2 years 3 months) |
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| Secondary | Percentage of Participants With Objective Response According to mRECIST v1.1 - Phase 3 | Objective response referred to participants with complete response (CR) or partial response (PR). CR: disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR: greater than or equal to (>=) 30% decrease in sum of the longest diameter (LD) of all target lesions taking as reference the screening sum LD. To be assigned a status of PR or CR, changes in tumor measurements had to be confirmed by repeat assessments that should have been performed no less than 4 weeks after the criteria for response were first met. Longer intervals as determined by the study protocol were also appropriate. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure. | ITT population included all randomized participants, participants grouped according to the therapy they were randomized to receive. Here, N=number of participants with measurable disease were included in analysis of this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Date of randomization until disease progression or death, whichever occurred first (assessed at baseline, every 6 weeks up to 2 years 3 months) |
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| Secondary | Duration of Objective Response (DOR) - Phase 3 | DOR: time from the date when a clinical response [CR or PR] was first documented to the date of first documented progressive disease (PD) or death. CR:disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR: >= 30% decrease in sum of the LD of all target lesions taking as reference the screening sum LD. PD: could base on symptom deterioration or at least a 20% increase in the sum of diameters of target or non-target lesions and new lesions, taking as reference the smallest sum on study (nadir), including baseline. To be assigned a status of PR or CR, changes in tumor measurements had to be confirmed by repeat assessments that should have been performed no less than 4 weeks after the criteria for response were first met. Longer intervals as determined by the study protocol were also appropriate. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure. | ITT population included all randomized participants, participants grouped according to the therapy they were randomized to receive. Here, N=number of participants evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | months | Date of randomization until disease progression or death, whichever occurred first (assessed at baseline, every 6 weeks up to 2 years 3 months) |
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| Secondary | Percentage of Participants With Clinically Significant Improvement in European Organisation for Research and Treatment of Cancer Quality of Life Core Module 30 (EORTC QLQ-C30) Score - Phase 3 | The EORTC QLQ-C30 is a validated, cancer-specific 30-item patient-reported measure, and contains 14 domains to assess the impact of cancer treatment on 5 aspects of participants functioning (physical, role, cognitive, emotional, and social), 9 aspects of disease/treatment-related symptoms (fatigue, nausea and vomiting, pain, dyspnea, insomnia, loss of appetite, constipation, diarrhea) and a global QoL/overall health status scale. Questions used 4 point scale (1 'Not at all' to 4 'Very much'; with the exception of the QoL/health status scale which uses a 7-point scale (1 'very poor' to 7 'Excellent'). Each scale is transformed on a scale of 0-100; a higher score equals (=) a better level of functioning or greater degree of symptoms. Change of greater than or equal to (>=) 10-points has been found to be clinically significant. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure. | ITT population included all randomized participants, participants grouped according to the therapy they were randomized to receive. Here, N=number of participants with baseline and at least one post-baseline valid score. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 of each treatment cycle, at the study drug completion visit, and thereafter at follow-up (up to 2 years 3 months) |
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| Secondary | Percentage of Participants With Clinically Significant Improvement in Quality of Life Questionnaire Stomach Cancer Module 22 (QLQ-STO22) Score - Phase 3 | The Quality of Life Questionnaire Stomach Cancer Module 22 (QLQ-STO22) supplements the EORTC QLQ-C30 to assess symptoms and treatment-related side effects commonly reported in participants. There are 22 questions which comprise 5 scales (dysphagia, pain, reflux symptom, dietary restrictions, and anxiety) and 4 single items (dry mouth, hair loss, taste, body image). Most questions use 4-point scale (1 'Not at all' to 4 'Very much'; 1 question was a yes or no answer). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100; higher score=better level of functioning or greater degree of symptoms. Change of >=10 points has been found to be clinically significant. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure. | ITT population included all randomized participants, participants grouped according to the therapy they were randomized to receive. Here, N=number of participants with baseline and at least one post-baseline valid score. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 of each treatment cycle, at the study drug completion visit, and thereafter at survival follow-up (up to 2 years 3 months) |
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| Secondary | Percentage of Participants With Advanced Gastric Cancer (AGC) Symptom Progression - Phase 3 | AGC symptomatic progression: a worsening of >=10-points in any 1 of the abdominal discomfort, loss of appetite, weakness and fatigue, upper abdominal pain, change in bowel movement, and/or weight loss scales of the EORTC QLQ-C30 and QLQ-STO22. QLQ-STO22 supplements EORTC QLQ-C30 to assess symptoms and commonly reported treatment-related side effects. There are 22 questions comprise 5 scales (dysphagia, pain, reflux symptom, diet restrictions, anxiety), 4 single items (dry mouth, hair loss, taste, body image), which are related to the symptoms of the disease. Most questions used 4-point scale (1 'Not at all' to 4 'Very much'). All scores and single-items transformed to a scale of 0-100; higher score=better level of functioning or greater degree of symptoms. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure. | ITT population included all randomized participants, participants grouped according to the therapy they were randomized to receive. Here, N=number of participants evaluable for this measure. | Posted | Number | percentage of participants | Day 1 of each treatment cycle, at the study drug completion visit, and thereafter at survival follow-up (up to 2 years 3 months) |
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| Secondary | Time to Advanced Gastric Cancer (AGC) Symptom Progression - Phase 3 | Time to AGC symptom were defined as the time from randomization to the first documentation of an increase in at least one of the pre-specified abdominal discomfort, loss of appetite, weakness and fatigue, upper abdominal pain, change in bowel movement, and weight loss subscales of the QLQ STO22 and EORTC QLQ-C30. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure. | ITT population included all randomized participants, participants grouped according to the therapy they were randomized to receive. Here, N=number of participants evaluable for this measure. | Posted | Median | 95% Confidence Interval | months | Day 1 of each treatment cycle, at the study drug completion visit, and thereafter at survival follow-up (up to 2 years 3 months) |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of Trastuzumab Emtansine (T-DM1) and Total Trastuzumab - Stage 1 | Maximum observed plasma concentration of Trastuzumab Emtansine (T-DM1) and total trastuzumab were reported. Stage 1 consists of all participants recruited before the regimen selection, which was carried out after 12 weeks of randomization. | Participants who had at least one PK parameter estimated were included for analysis. Here, n=number of participants evaluable at specified timepoint. | Posted | Mean | Standard Deviation | microgram per milliliter (mcg/mL) | Day 1 (D1) of Cycle 1 (C1) and C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks) |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of N2'-Deacetyl-N2'-(3-mercapto-1-oxopropyl)-Maytansine (DM1) - Stage 1 | Maximum observed plasma concentration of DM1 were reported. Stage 1 consists of all participants recruited before the regimen selection decision. Regimen selection analysis was carried out after 12 weeks of randomization. | Participants who had at least one PK parameter estimated were included for analysis. Here, n=number of participants evaluable at specified timepoint. | Posted | Mean | Standard Deviation | nanogram per milliliter (mcg/mL) | C1D1 and C1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks) |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of Trastuzumab Emtansine (T-DM1) and Total Trastuzumab - Stage 2 | Stage 2 consists of all participants recruited after the regimen selection decision up to primary data cut-off date 30-June-2015. | Participants who had at least one PK parameter estimated were included for analysis. Here, n=number of participants evaluable at specified timepoint. | Posted | Mean | Standard Deviation | mcg/mL | C1D1; C4D1 |
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| Secondary | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf] - Stage 1 | AUCinf= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf). Stage 1 consists of all participants recruited before the regimen selection decision. Regimen selection analysis was carried out after 12 weeks of randomization. | Participants who had at least one PK parameter estimated were included for analysis. | Posted | Mean | Standard Deviation | day*mcg/mL | D1C1 and D1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks) |
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| Secondary | Plasma Decay Half-Life (t1/2) - Stage 1 | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Stage 1 consists of all participants recruited before the regimen selection decision. Regimen selection analysis was carried out after 12 weeks of randomization. | Participants who had at least one PK parameter estimated were included for analysis. | Posted | Mean | Standard Deviation | days | D1C1 and D1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks) |
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| Secondary | Volume of Distribution at Steady State (Vss) - Stage 1 | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. Stage 1 consists of all participants recruited before the regimen selection decision. Regimen selection analysis was carried out after 12 weeks of randomization. | Participants who had at least one PK parameter estimated were included for analysis. | Posted | Mean | Standard Deviation | milliliter per kilogram (mL/kg) | D1C1 and D1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks) |
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| Secondary | Systemic Clearance (CL) - Stage 1 | CL is a quantitative measure of the rate at which a drug substance is removed from the body. Stage 1 consists of all participants recruited before the regimen selection decision. Regimen selection analysis was carried out after 12 weeks of randomization. | Participants who had at least one PK parameter estimated were included for analysis. | Posted | Mean | Standard Deviation | mL/day/kg | D1C1 and D1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks) |
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Baseline up to data cut-off date 30-April-2016 (up to 3 years 8 months)
Safety Analysis Population included all participants who received at least one dose of study medication. The safety parameters were analyzed and presented according to the therapy participants received. Cumulative data (up to primary analysis cut-off date of 30-April-2016) are provided for both phase 2 and phase 3.
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 | Standard Taxane Therapy | Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue. | 31 | 111 | 105 | 111 | ||
| EG001 | Trastuzumab Emtansine 2.4 mg | Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue. | 65 | 224 | 211 | 224 | ||
| EG002 | Trastuzumab Emtansine 3.6 mg | Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue. | 23 | 69 | 62 | 69 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Coagulopathy | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Gastrointestinal ulcer | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Haematemesis | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Jejunal perforation | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Oesophageal haemorrhage | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Oesophageal stenosis | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Regurgitation | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Small intestinal haemorrhage | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Death | General disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA 18.0 | Non-systematic Assessment |
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| General physical health deterioration | General disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Bile duct stenosis | Hepatobiliary disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Cholangitis acute | Hepatobiliary disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Anaphylactic reaction | Immune system disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
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| Device related infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
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| Escherichia infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
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| Gastrointestinal infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
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| Infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
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| Lower respiratory tract infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
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| Lung abscess | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
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| Lung infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
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| Meningitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
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| Staphylococcal sepsis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
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| Overdose | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hypophagia | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Non-systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Non-systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pulmonary alveolar haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Intervertebral discitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Weight decereased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Deceased appetite | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Insominia | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
|
The study was terminated by the Sponsor as the primary analysis results did not meet the primary endpoint.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-LaRoche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C080625 | taxane |
| D000080044 | Ado-Trastuzumab Emtansine |
| ID | Term |
|---|---|
| D008453 | Maytansine |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D000068878 | Trastuzumab |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| OG002 | Trastuzumab Emtansine 2.4 mg | Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue. |
|
|
|
Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
|
|
| OG001 | Trastuzumab Emtansine 2.4 mg | Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue. |
|
|
|
| OG001 | Trastuzumab Emtansine 2.4 mg | Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue. |
|
|
| OG001 | Trastuzumab Emtansine 2.4 mg | Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue. |
|
|
| OG001 | Trastuzumab Emtansine 2.4 mg | Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue. |
|
|
| OG001 | Trastuzumab Emtansine 2.4 mg | Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue. |
|
|
| OG001 | Trastuzumab Emtansine 2.4 mg | Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue. |
|
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