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| ID | Type | Description | Link |
|---|---|---|---|
| I4T-IE-JVBE | Other Identifier | Eli Lilly and Company | |
| CP12-0922 | Other Identifier | ImClone Systems | |
| 2010-020426-18 | EudraCT Number |
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This is a Phase III randomized multicenter double-blind, placebo controlled trial evaluating the safety and efficacy of paclitaxel plus ramucirumab (IMC-1211B) drug product (DP) compared to paclitaxel plus placebo.
The aim of this study is to determine if paclitaxel given together with ramucirumab (IMC-1211B) as second line therapy will prolong overall survival (OS) compared to paclitaxel alone.
Approximately 663 participants (at least 18 years) in approximately 200 study centers and in approximately 30 countries will be randomized with histologically or cytologically confirmed metastatic gastric or gastroesophageal junction adenocarcinoma. Participants must have received at least one cycle of first line therapy with any platinum/fluoropyrimidine doublet with or without anthracycline (epirubicin or doxorubicin) and must have discontinued this therapy prior to study entry due to disease progression.
Upon registration and completion of screening procedure and reviewing the Inclusion and Exclusion Criteria eligible participants will be randomized to receive either paclitaxel plus ramucirumab or paclitaxel plus placebo.
Ramucirumab (IMC-1211B) DP/placebo will be administered IV on Days 1 and 15, paclitaxel will be administered IV on Days 1, 8 and 15 of a 4 weekly cycle.
Participants will be continuously treated and monitored until radiographic or symptomatic progression of disease, toxicity requiring cessation, protocol noncompliance, or withdrawal of consent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ramucirumab (IMC-1211B) Drug Product (DP) and Paclitaxel | Experimental | Ramucirumab (IMC-1211B) DP and Paclitaxel |
|
| Placebo and Paclitaxel | Placebo Comparator | Placebo and Paclitaxel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ramucirumab (IMC-1211B) DP | Biological | 8 milligrams/kilogram (mg/kg) intravenous (IV) infusion on Days 1 and 15 of every 4-week cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival Time (OS) | OS time was measured from date of randomization to date of death from any cause. Participants who were not known to have died on or before the date of data cut-off, OS data was censored on the last date (on or before the cut-off date) the participant was known to be alive. | Randomization up to 27.5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS was measured from date of randomization to first radiographically documented progressive disease (PD) or death due to any cause. PD defined using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of at least 5 mm. Participants who had no baseline or post baseline radiological tumor assessment were censored at date of randomization. Participants who had no tumor progression or death within 2 scan intervals following the last assessment were censored at the date of last radiographic tumor assessment. Participants who began new anticancer treatment and had no tumor progression were censored at date of assessment prior to initiation of new therapy. Participants lost to follow-up or withdrew consent were censored at the date of their last assessment. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Serious and Other Non-serious Adverse Events (AE) and Who Died | Participants who died or who had clinically significant events defined as serious AEs (SAEs) and other non-serious AEs (regardless of causality). A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module. | Baseline up to 103 weeks and within 30 days of last dose of study drug |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ImClone Investigational Site | Burbank | California | 91505 | United States | ||
| ImClone Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37129153 | Derived | Ogata T, Narita Y, Wainberg ZA, Van Cutsem E, Yamaguchi K, Piao Y, Zhao Y, Peterson PM, Wijayawardana SR, Abada P, Chatterjee A, Muro K. Exploratory Analysis of Patients With Gastric/Gastroesophageal Junction Adenocarcinoma With or Without Liver Metastasis From the Phase 3 RAINBOW Study. J Gastric Cancer. 2023 Apr;23(2):289-302. doi: 10.5230/jgc.2023.23.e15. | |
| 34795131 |
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Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Completers include participants that discontinued study drugs either due to progressive disease (PD), due to an adverse event or died due to any cause, but not necessarily had any survival-FU assessment done.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ramucirumab (IMC-1211B) Plus Paclitaxel | 8 milligrams/kilogram (mg/kg) of ramucirumab (IMC-1121B) was administered by intravenous (IV) infusion on Days 1 and 15 in combination with 80 milligrams/square meter (mg/m²) paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle. |
| FG001 |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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|
| Placebo | Drug | Ramucirumab placebo IV infusion on Days 1 and 15 of every 4-week cycle |
|
| Paclitaxel | Drug | Paclitaxel 80 milligrams per square meter (mg/m²) IV infusion on Days 1, 8, and 15 of every 4-week cycle |
|
| Randomization up to 22.2 months |
| Time to Progressive Disease (TTP) | TTP was defined as the time from randomization until date of radiographic progression using RECIST v1.1 criteria. PD was defined as having a ≥20% increase in sum of longest diameter (LD) of target lesions and at minimum 5 millimeters (mm) increase above nadir. Participants who did not progress or were lost to follow-up were censored at the date of last tumor assessment. Participants who had no baseline tumor assessment or no post baseline assessment and no death reported with 2 scan intervals post randomization were censored at date of randomization. Participants with no progression and not died within 2 scan intervals after last assessment were censored at date of last tumor assessment. Participants with no post baseline assessment or tumor progression but death reported within 2 scan intervals after randomization were censored at date of death. | Baseline up to 22.2 months |
| Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), Stable Disease (SD) or PD | BOR was defined as the best response across all time points from randomization until radiologically confirmed PD using RECIST, v1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm and normalization of tumor marker level of non-target lesions. PR was defined as having a ≥30% decrease in sum of LD of target lesions. PD was defined as having a ≥20% increase in sum of LD of target lesions and ≥5 mm increase above nadir. SD was defined as small changes that did not meet above criteria. | Randomization up to 22.2 months |
| Percentage of Participants With CR or PR (Objective Response Rate [ORR]) | ORR was the percentage of participants who had CR or PR defined using RECIST v1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm and normalization of tumor marker level of non-target lesions. PR was defined as having a ≥30% decrease in sum of LD of target lesions. Percentage of participants calculated as: (number of participants with CR + PR)/(total number of participants)*100. | Randomization up to 22.2 months |
| Percentage of Participants With Anti-Ramucirumab Antibodies (Serum Anti-Ramucirumab Antibody Assessment )(Immunogenicity) | Participants who developed treatment-emergent antibody responses to Ramucirumab (IMC-1121B) after baseline. | Prior to and after ramucirumab (IMC-1121B) infusion: Day 1 Cycles 1, 2 and 3 (28-day cycles) Doses 1, 4, 7 and 30-37 days after last dose of study therapy up to 103 weeks |
| Maximum Concentration (Cmax) After First Ramucirumab (IMC-1211B) Infusion | Cycle 1, Day 1, 1 hour post end of infusion (28-day cycles) |
| Cmax After 4th Ramucirumab (IMC-1211B) Infusion | Cycle 2, Day 15 1 hour post end of infusion (28-day cycles) |
| Cmax After 7th Ramucirumab (IMC-1211B) Infusion | Cycle 4, Day 1, 1 hour post end of infusion (28-day cycles) |
| Minimum Concentration (Cmin) Prior to First Ramucirumab (IMC-1211B) Infusion | This outcome measure was included in error as the time point was before ramucirumab (IMC-1211B) was administered. Cmin was not analyzed. | Cycle 1, Day 1 predose (28-day cycles) |
| Cmin Prior to 4th Ramucirumab (IMC-1211B) Infusion | Cycle 2, Day 15 (28-day cycle) |
| Cmin Prior to 7th Ramucirumab (IMC-1211B) Infusion | Cycle 4, Day 1 (28-day cycles) |
| Change From Baseline to End of Therapy in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life: Questionnaire (QLQ-C30) in Global Health Status | EORTC QLQ-C30 v3.0 is a 30-item, self-administered questionnaire with multidimensional scales assessing 15 domains (5 functional domains [physical, role, cognitive, emotional, and social], 9 symptom scales [fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties] and global health status scale). 28 questions assessed on a 1 (not at all) to 4 (very much) scale and the remaining 2 questions used a 1 (poor) to 7 (excellent) scale. A linear transformation was applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For the functional domains and global health status scale, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms. | Baseline, end of therapy (up to 103 weeks) |
| Change From Baseline to End of Therapy in European Quality of Life Questionnaire-5 Dimension (EuroQol EQ-5D) Index Score | The EQ-5D is a generic, multidimensional, health status instrument. The profile allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale [1 (no problem), 2 (some problems), and 3 (major problems)]. These combinations of responses were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). A negative change indicated a worsening of the participant's health status. | Baseline, end of therapy (up to 103 weeks) |
| Los Angeles |
| California |
| 90095 |
| United States |
| ImClone Investigational Site | San Francisco | California | 94115 | United States |
| ImClone Investigational Site | Jacksonville | Florida | 32207 | United States |
| ImClone Investigational Site | Miramar | Florida | 33027 | United States |
| ImClone Investigational Site | Atlanta | Georgia | 30322 | United States |
| ImClone Investigational Site | Honolulu | Hawaii | 96813 | United States |
| ImClone Investigational Site | East Orange | New Jersey | 07018 | United States |
| ImClone Investigational Site | Albuquerque | New Mexico | 87131 | United States |
| ImClone Investigational Site | New York | New York | 10016 | United States |
| ImClone Investigational Site | Chattanooga | Tennessee | 37404 | United States |
| ImClone Investigational Site | Houston | Texas | 77030 | United States |
| ImClone Investigational Site | Seattle | Washington | 98109 | United States |
| ImClone Investigational Site | Buenos Aires | C1019ABS | Argentina |
| ImClone Investigational Site | Caba | C1050AAK | Argentina |
| ImClone Investigational Site | Rosario | 2000 | Argentina |
| ImClone Investigational Site | Santa Fe | 3000 | Argentina |
| ImClone Investigational Site | Bankstown | New South Wales | 2200 | Australia |
| ImClone Investigational Site | Kogarah | New South Wales | 2217 | Australia |
| ImClone Investigational Site | Liverpool | New South Wales | 2170 | Australia |
| ImClone Investigational Site | Wollongong | New South Wales | 2500 | Australia |
| ImClone Investigational Site | Southport | Queensland | 4215 | Australia |
| ImClone Investigational Site | Kurralta Park | South Australia | 5037 | Australia |
| ImClone Investigational Site | Coburg | Victoria | 3058 | Australia |
| ImClone Investigational Site | Footscray | Victoria | 3011 | Australia |
| ImClone Investigational Site | Frankston | Victoria | 3199 | Australia |
| ImClone Investigational Site | Parkville | Victoria | 3050 | Australia |
| ImClone Investigational Site | Graz | 8036 | Austria |
| ImClone Investigational Site | Linz | A-4010 | Austria |
| ImClone Investigational Site | Steyr | 4400 | Austria |
| ImClone Investigational Site | Vienna | 1100 | Austria |
| ImClone Investigational Site | Bonheiden | 2820 | Belgium |
| ImClone Investigational Site | Bruges | 8310 | Belgium |
| ImClone Investigational Site | Brussels | 1000 | Belgium |
| ImClone Investigational Site | Brussels | 1070 | Belgium |
| ImClone Investigational Site | Edegem | 2650 | Belgium |
| ImClone Investigational Site | Leuven | 3000 | Belgium |
| ImClone Investigational Site | Belo Horizonte | 30130-100 | Brazil |
| ImClone Investigational Site | Belo Horizonte | 30150-281 | Brazil |
| ImClone Investigational Site | Caxias do Sul | 95070560 | Brazil |
| ImClone Investigational Site | Dois Lajeados | 95900-000 | Brazil |
| ImClone Investigational Site | Gávea | 22451-010 | Brazil |
| ImClone Investigational Site | Ijuí | 98700 000 | Brazil |
| ImClone Investigational Site | Itajaí | 88301-170 | Brazil |
| ImClone Investigational Site | Londrina | 86050-190 | Brazil |
| ImClone Investigational Site | Passo Fundo | 99010-260 | Brazil |
| ImClone Investigational Site | Porto Alegre | 90035-903 | Brazil |
| ImClone Investigational Site | Porto Alegre-Rs | 90020090 | Brazil |
| ImClone Investigational Site | Ribeirão Preto | 14015-130 | Brazil |
| ImClone Investigational Site | Rio de Janeiro | 20231-050 | Brazil |
| ImClone Investigational Site | Salvador | 41820-021 | Brazil |
| ImClone Investigational Site | Sao Jose Rio Preto | 15090-000 | Brazil |
| ImClone Investigational Site | São Paulo | 01246-000 | Brazil |
| ImClone Investigational Site | São Paulo | 04122-000 | Brazil |
| ImClone Investigational Site | São Paulo | Brazil |
| ImClone Investigational Site | Sorocaba | 18031-000 | Brazil |
| ImClone Investigational Site | Sofia | 1756 | Bulgaria |
| ImClone Investigational Site | Varna | 9000 | Bulgaria |
| ImClone Investigational Site | Providencia | Chile |
| ImClone Investigational Site | Viña del Mar | Chile |
| ImClone Investigational Site | Tallinn | 10138 | Estonia |
| ImClone Investigational Site | Tallinn | 13419 | Estonia |
| ImClone Investigational Site | Besançon | 25030 | France |
| ImClone Investigational Site | Brest | 29609 | France |
| ImClone Investigational Site | Clermont-Ferrand | 63003 | France |
| ImClone Investigational Site | Marseille | 13385 | France |
| ImClone Investigational Site | Montbéliard | 25200 | France |
| ImClone Investigational Site | Montpellier | 34298 | France |
| ImClone Investigational Site | Paris | 75013 | France |
| ImClone Investigational Site | Paris | 75015 | France |
| ImClone Investigational Site | Paris | 75475 | France |
| ImClone Investigational Site | Saint-Etienne | 42055 | France |
| ImClone Investigational Site | Berlin | 13353 | Germany |
| ImClone Investigational Site | Bielefeld | 33611 | Germany |
| ImClone Investigational Site | Dresden | 01307 | Germany |
| ImClone Investigational Site | Essen | 45136 | Germany |
| ImClone Investigational Site | Frankfurt | 60596 | Germany |
| ImClone Investigational Site | Hamburg | 22087 | Germany |
| ImClone Investigational Site | Heidelberg | 69115 | Germany |
| ImClone Investigational Site | Leipzig | 04103 | Germany |
| ImClone Investigational Site | Mainz | 55131 | Germany |
| ImClone Investigational Site | Munich | 81737 | Germany |
| ImClone Investigational Site | Recklinghausen | 45657 | Germany |
| ImClone Investigational Site | Tübingen | 72076 | Germany |
| ImClone Investigational Site | Budapest | 1125 | Hungary |
| ImClone Investigational Site | Gyula | 5700 | Hungary |
| ImClone Investigational Site | Kaposvár | 7400 | Hungary |
| ImClone Investigational Site | Pécs | 7624 | Hungary |
| ImClone Investigational Site | Székesfehérvár | 8000 | Hungary |
| ImClone Investigational Site | Beersheba | 84101 | Israel |
| ImClone Investigational Site | Haifa | 31096 | Israel |
| ImClone Investigational Site | Holon | 58100 | Israel |
| ImClone Investigational Site | Jerusalem | 91120 | Israel |
| ImClone Investigational Site | Petah Tikva | 49100 | Israel |
| ImClone Investigational Site | Tel Aviv | 64239 | Israel |
| ImClone Investigational Site | Tel Litwinsky | 52661 | Israel |
| ImClone Investigational Site | Ancona | 60100 | Italy |
| ImClone Investigational Site | Bari | 70126 | Italy |
| ImClone Investigational Site | Bergamo | 24125 | Italy |
| ImClone Investigational Site | Catania | 95122 | Italy |
| ImClone Investigational Site | Genova | 16132 | Italy |
| ImClone Investigational Site | Milan | 20121 | Italy |
| ImClone Investigational Site | Padova | 35128 | Italy |
| ImClone Investigational Site | Pisa | 56126 | Italy |
| ImClone Investigational Site | Torino | 10100 | Italy |
| ImClone Investigational Site | Aichi | 464 | Japan |
| ImClone Investigational Site | Chiba | 277 8577 | Japan |
| ImClone Investigational Site | Ehime | 790-0007 | Japan |
| ImClone Investigational Site | Fukuoka | 811-1395 | Japan |
| ImClone Investigational Site | Hokkaido | 060-0814 | Japan |
| ImClone Investigational Site | Kochi | 781-8555 | Japan |
| ImClone Investigational Site | Osaka | 569-8686 | Japan |
| ImClone Investigational Site | Osaka-Pref | 589 | Japan |
| ImClone Investigational Site | Ōita | 8795593 | Japan |
| ImClone Investigational Site | Saitama | 362-0806 | Japan |
| ImClone Investigational Site | Shizuoka | 411-8777 | Japan |
| ImClone Investigational Site | Tochigi | 320-0834 | Japan |
| ImClone Investigational Site | Tokyo | 181-8611 | Japan |
| ImClone Investigational Site | Kaunas | LT-50009 | Lithuania |
| ImClone Investigational Site | Klaipėda | LT-92288 | Lithuania |
| ImClone Investigational Site | Juchitán | 70000 | Mexico |
| ImClone Investigational Site | Nuevo León | 64060 | Mexico |
| ImClone Investigational Site | Brzozów | 36-200 | Poland |
| ImClone Investigational Site | Bydgoszcz | 85-769 | Poland |
| ImClone Investigational Site | Gdansk | 80-210 | Poland |
| ImClone Investigational Site | Lodz | 93-509 | Poland |
| ImClone Investigational Site | Lublin | 20-090 | Poland |
| ImClone Investigational Site | Poznan | 61- 485 | Poland |
| ImClone Investigational Site | Warsaw | 02-781 | Poland |
| ImClone Investigational Site | Aveiro | 3814-501 | Portugal |
| ImClone Investigational Site | Coimbra | 3001-651 | Portugal |
| ImClone Investigational Site | Evora | 7000-811 | Portugal |
| ImClone Investigational Site | Porto | 4202-451 | Portugal |
| ImClone Investigational Site | Santa Maria da Feira | 4520-211 | Portugal |
| ImClone Investigational Site | Baia Mare | 430031 | Romania |
| ImClone Investigational Site | Bucharest | Romania |
| ImClone Investigational Site | Iași | 700106 | Romania |
| ImClone Investigational Site | Târgu Mureş | 540072 | Romania |
| ImClone Investigational Site | Krasnodar | 350040 | Russia |
| ImClone Investigational Site | Moscow | 115478 | Russia |
| ImClone Investigational Site | Perm | 614066 | Russia |
| ImClone Investigational Site | Saint Petersburg | 191025 | Russia |
| ImClone Investigational Site | Ufa | 450054 | Russia |
| ImClone Investigational Site | Singapore | 258499 | Singapore |
| ImClone Investigational Site | Incheon | 405-760 | South Korea |
| ImClone Investigational Site | Seongnam-si | 463-707 | South Korea |
| ImClone Investigational Site | Seoul | 110-744 | South Korea |
| ImClone Investigational Site | Suwon | 442-723 | South Korea |
| ImClone Investigational Site | Suwon | 443-721 | South Korea |
| ImClone Investigational Site | Ávila | 05004 | Spain |
| ImClone Investigational Site | Burgos | 9005 | Spain |
| ImClone Investigational Site | Jerez de la Frontera | 11407 | Spain |
| ImClone Investigational Site | Madrid | 28041 | Spain |
| ImClone Investigational Site | Majadahonda | 28222 | Spain |
| ImClone Investigational Site | Palma de Mallorca | 07014 | Spain |
| ImClone Investigational Site | Sabadell | 08208 | Spain |
| ImClone Investigational Site | Seville | 41009 | Spain |
| ImClone Investigational Site | Changhua | 500 | Taiwan |
| ImClone Investigational Site | Kaohsiung City | 833 | Taiwan |
| ImClone Investigational Site | Liouying/Tainan | 736 | Taiwan |
| ImClone Investigational Site | Taichung | 404 | Taiwan |
| ImClone Investigational Site | Tainan | 70403 | Taiwan |
| ImClone Investigational Site | Taipei | 112 | Taiwan |
| ImClone Investigational Site | Maidstone | Kent | ME16 9QQ | United Kingdom |
| ImClone Investigational Site | Guildford | Surrey | GU2 7XX | United Kingdom |
| ImClone Investigational Site | Sutton | Surrey | SM2 5PT | United Kingdom |
| ImClone Investigational Site | Wolverhampton | West Midlands | WV10 0QP | United Kingdom |
| Mitani S, Chen Y, Inoue K, Mori J, Gao L, Long A, Wakabayashi S. Clinical Impact of a Shortened Infusion Duration of Ramucirumab in Japanese Patients -A Model-Based Approach. Gan To Kagaku Ryoho. 2021 Nov;48(11):1381-1387. |
| 33355909 | Derived | Yamaguchi K, Shimada Y, Hironaka S, Sugimoto N, Komatsu Y, Nishina T, Omuro Y, Tamura T, Piao Y, Homma G, Jen MH, Liepa AM, Muro K. Quality of Life Associated with Ramucirumab Treatment in Patients with Advanced Gastric Cancer in Japan: Exploratory Analysis from the Phase III RAINBOW Trial. Clin Drug Investig. 2021 Jan;41(1):53-64. doi: 10.1007/s40261-020-00979-3. Epub 2020 Dec 23. |
| 33274542 | Derived | Cascinu S, Bodoky G, Muro K, Van Cutsem E, Oh SC, Folprecht G, Ananda S, Girotto G, Wainberg ZA, Miron MLL, Ajani J, Wei R, Liepa AM, Carlesi R, Emig M, Ohtsu A. Tumor Response and Symptom Palliation from RAINBOW, a Phase III Trial of Ramucirumab Plus Paclitaxel in Previously Treated Advanced Gastric Cancer. Oncologist. 2021 Mar;26(3):e414-e424. doi: 10.1002/onco.13623. Epub 2020 Dec 23. |
| 31234645 | Derived | De Vita F, Borg C, Farina G, Geva R, Carton I, Cuku H, Wei R, Muro K. Ramucirumab and paclitaxel in patients with gastric cancer and prior trastuzumab: subgroup analysis from RAINBOW study. Future Oncol. 2019 Aug;15(23):2723-2731. doi: 10.2217/fon-2019-0243. Epub 2019 Jun 25. |
| 30557792 | Derived | Chau I, Fuchs CS, Ohtsu A, Barzi A, Liepa AM, Cui ZL, Hsu Y, Al-Batran SE. Association of quality of life with disease characteristics and treatment outcomes in patients with advanced gastric cancer: Exploratory analysis of RAINBOW and REGARD phase III trials. Eur J Cancer. 2019 Jan;107:115-123. doi: 10.1016/j.ejca.2018.11.013. Epub 2018 Dec 14. |
| 28716815 | Derived | Tabernero J, Ohtsu A, Muro K, Van Cutsem E, Oh SC, Bodoky G, Shimada Y, Hironaka S, Ajani JA, Tomasek J, Safran H, Chandrawansa K, Hsu Y, Heathman M, Khan A, Ni L, Melemed AS, Gao L, Ferry D, Fuchs CS. Exposure-Response Analyses of Ramucirumab from Two Randomized, Phase III Trials of Second-line Treatment for Advanced Gastric or Gastroesophageal Junction Cancer. Mol Cancer Ther. 2017 Oct;16(10):2215-2222. doi: 10.1158/1535-7163.MCT-16-0895. Epub 2017 Jul 17. |
| 26747859 | Derived | Al-Batran SE, Van Cutsem E, Oh SC, Bodoky G, Shimada Y, Hironaka S, Sugimoto N, Lipatov ON, Kim TY, Cunningham D, Rougier P, Muro K, Liepa AM, Chandrawansa K, Emig M, Ohtsu A, Wilke H. Quality-of-life and performance status results from the phase III RAINBOW study of ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated gastric or gastroesophageal junction adenocarcinoma. Ann Oncol. 2016 Apr;27(4):673-9. doi: 10.1093/annonc/mdv625. Epub 2016 Jan 7. |
| 26510663 | Derived | Shitara K, Muro K, Shimada Y, Hironaka S, Sugimoto N, Komatsu Y, Nishina T, Yamaguchi K, Segawa Y, Omuro Y, Tamura T, Doi T, Yukisawa S, Yasui H, Nagashima F, Gotoh M, Esaki T, Emig M, Chandrawansa K, Liepa AM, Wilke H, Ichimiya Y, Ohtsu A. Subgroup analyses of the safety and efficacy of ramucirumab in Japanese and Western patients in RAINBOW: a randomized clinical trial in second-line treatment of gastric cancer. Gastric Cancer. 2016 Jul;19(3):927-38. doi: 10.1007/s10120-015-0559-z. Epub 2015 Oct 28. |
| 25240821 | Derived | Wilke H, Muro K, Van Cutsem E, Oh SC, Bodoky G, Shimada Y, Hironaka S, Sugimoto N, Lipatov O, Kim TY, Cunningham D, Rougier P, Komatsu Y, Ajani J, Emig M, Carlesi R, Ferry D, Chandrawansa K, Schwartz JD, Ohtsu A; RAINBOW Study Group. Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a double-blind, randomised phase 3 trial. Lancet Oncol. 2014 Oct;15(11):1224-35. doi: 10.1016/S1470-2045(14)70420-6. Epub 2014 Sep 17. |
| Placebo Plus Paclitaxel |
Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle. |
|
| Received Any Treatment (Safety Pop) |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ramucirumab (IMC-1211B) Plus Paclitaxel | 8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle. |
| BG001 | Placebo Plus Paclitaxel | Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle. |
| 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, Categorical | Count of Participants | Participants | No |
| |||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
| |||||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
|
| 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 Time (OS) | OS time was measured from date of randomization to date of death from any cause. Participants who were not known to have died on or before the date of data cut-off, OS data was censored on the last date (on or before the cut-off date) the participant was known to be alive. | All participants according to the treatment group to which they were randomized. Participants censored: Ramucirumab (IMC-1211B) plus Paclitaxel =74, Placebo plus Paclitaxel =75. | Posted | Median | 95% Confidence Interval | months | Randomization up to 27.5 months |
|
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) | PFS was measured from date of randomization to first radiographically documented progressive disease (PD) or death due to any cause. PD defined using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of at least 5 mm. Participants who had no baseline or post baseline radiological tumor assessment were censored at date of randomization. Participants who had no tumor progression or death within 2 scan intervals following the last assessment were censored at the date of last radiographic tumor assessment. Participants who began new anticancer treatment and had no tumor progression were censored at date of assessment prior to initiation of new therapy. Participants lost to follow-up or withdrew consent were censored at the date of their last assessment. | All participants according to the treatment group to which they were randomized. Participants censored: Ramucirumab (IMC-1211B) plus Paclitaxel =51, Placebo plus Paclitaxel =39. | Posted | Median | 95% Confidence Interval | months | Randomization up to 22.2 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Progressive Disease (TTP) | TTP was defined as the time from randomization until date of radiographic progression using RECIST v1.1 criteria. PD was defined as having a ≥20% increase in sum of longest diameter (LD) of target lesions and at minimum 5 millimeters (mm) increase above nadir. Participants who did not progress or were lost to follow-up were censored at the date of last tumor assessment. Participants who had no baseline tumor assessment or no post baseline assessment and no death reported with 2 scan intervals post randomization were censored at date of randomization. Participants with no progression and not died within 2 scan intervals after last assessment were censored at date of last tumor assessment. Participants with no post baseline assessment or tumor progression but death reported within 2 scan intervals after randomization were censored at date of death. | All participants according to the treatment group to which they were randomized. Participants censored: Ramucirumab (IMC-1211B) plus Paclitaxel =107, Placebo plus Paclitaxel =94. | Posted | Median | 95% Confidence Interval | months | Baseline up to 22.2 months |
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| Secondary | Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), Stable Disease (SD) or PD | BOR was defined as the best response across all time points from randomization until radiologically confirmed PD using RECIST, v1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm and normalization of tumor marker level of non-target lesions. PR was defined as having a ≥30% decrease in sum of LD of target lesions. PD was defined as having a ≥20% increase in sum of LD of target lesions and ≥5 mm increase above nadir. SD was defined as small changes that did not meet above criteria. | All participants according to the treatment group to which they were randomized. | Posted | Number | percentage of participants | Randomization up to 22.2 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With CR or PR (Objective Response Rate [ORR]) | ORR was the percentage of participants who had CR or PR defined using RECIST v1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm and normalization of tumor marker level of non-target lesions. PR was defined as having a ≥30% decrease in sum of LD of target lesions. Percentage of participants calculated as: (number of participants with CR + PR)/(total number of participants)*100. | All participants according to the treatment group to which they were randomized. | Posted | Number | 95% Confidence Interval | percentage of participants | Randomization up to 22.2 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Anti-Ramucirumab Antibodies (Serum Anti-Ramucirumab Antibody Assessment )(Immunogenicity) | Participants who developed treatment-emergent antibody responses to Ramucirumab (IMC-1121B) after baseline. | All participants according to the treatment group to which they were randomized and received at least 1 dose of study drug with anti-ramucirumab antibodies. | Posted | Number | percentage of participants | Prior to and after ramucirumab (IMC-1121B) infusion: Day 1 Cycles 1, 2 and 3 (28-day cycles) Doses 1, 4, 7 and 30-37 days after last dose of study therapy up to 103 weeks |
|
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| Secondary | Maximum Concentration (Cmax) After First Ramucirumab (IMC-1211B) Infusion | All participants who received Ramucirumab (IMC-1121B) plus Paclitaxel and had Cmax observations at specific timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms/milliliter (µg/mL) | Cycle 1, Day 1, 1 hour post end of infusion (28-day cycles) |
|
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| Secondary | Cmax After 4th Ramucirumab (IMC-1211B) Infusion | All participants who received Ramucirumab (IMC-1121B) plus Paclitaxel and had Cmax observations at specific timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | Cycle 2, Day 15 1 hour post end of infusion (28-day cycles) |
|
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| Secondary | Cmax After 7th Ramucirumab (IMC-1211B) Infusion | All participants who received Ramucirumab (IMC-1121B) plus Paclitaxel and had Cmax observations at specific timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | Cycle 4, Day 1, 1 hour post end of infusion (28-day cycles) |
|
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| Secondary | Minimum Concentration (Cmin) Prior to First Ramucirumab (IMC-1211B) Infusion | This outcome measure was included in error as the time point was before ramucirumab (IMC-1211B) was administered. Cmin was not analyzed. | Zero participants were analyzed. | Posted | Cycle 1, Day 1 predose (28-day cycles) |
|
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| Secondary | Cmin Prior to 4th Ramucirumab (IMC-1211B) Infusion | All participants who received Ramucirumab (IMC-1121B) plus Paclitaxel and had Cmin observations at specific timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | Cycle 2, Day 15 (28-day cycle) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cmin Prior to 7th Ramucirumab (IMC-1211B) Infusion | All participants who received Ramucirumab (IMC-1121B) plus Paclitaxel and had Cmin observations at specific timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | Cycle 4, Day 1 (28-day cycles) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to End of Therapy in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life: Questionnaire (QLQ-C30) in Global Health Status | EORTC QLQ-C30 v3.0 is a 30-item, self-administered questionnaire with multidimensional scales assessing 15 domains (5 functional domains [physical, role, cognitive, emotional, and social], 9 symptom scales [fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties] and global health status scale). 28 questions assessed on a 1 (not at all) to 4 (very much) scale and the remaining 2 questions used a 1 (poor) to 7 (excellent) scale. A linear transformation was applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For the functional domains and global health status scale, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms. | All participants according to the treatment group to which they were randomized with baseline and end of treatment Global Health Status observations. | Posted | Mean | Standard Deviation | units on a scale | Baseline, end of therapy (up to 103 weeks) |
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| Secondary | Change From Baseline to End of Therapy in European Quality of Life Questionnaire-5 Dimension (EuroQol EQ-5D) Index Score | The EQ-5D is a generic, multidimensional, health status instrument. The profile allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale [1 (no problem), 2 (some problems), and 3 (major problems)]. These combinations of responses were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). A negative change indicated a worsening of the participant's health status. | All participants according to the treatment group to which they were randomized with baseline and end of treatment EQ-5D observations. | Posted | Mean | Standard Deviation | units on a scale | Baseline, end of therapy (up to 103 weeks) |
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| Other Pre-specified | Number of Participants With Serious and Other Non-serious Adverse Events (AE) and Who Died | Participants who died or who had clinically significant events defined as serious AEs (SAEs) and other non-serious AEs (regardless of causality). A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module. | All randomized participants who received at least 1 dose of study drug and based on the treatment each participant received. | Posted | Number | participants | Baseline up to 103 weeks and within 30 days of last dose of study drug |
|
|
Not provided
One (1) participant was randomized to the placebo group but received ramucirumab in error. This participant was included in the ramucirumab group in the Safety population (as treated).
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 | Ramucirumab and Paclitaxel | 8 mg/kg ramucirumab (IMC1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle. | 161 | 327 | 324 | 327 | ||
| EG001 | Placebo and Paclitaxel | Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² administered on Days 1, 8, and 15 of a 28-day cycle. | 146 | 329 | 321 | 329 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Atrial thrombosis | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Extrasystoles | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pyloric stenosis | Congenital, familial and genetic disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hearing impaired | Ear and labyrinth disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Anal haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Aphagia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Diverticular perforation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Gastrointestinal obstruction | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Malabsorption | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Obstruction gastric | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Oesophageal food impaction | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Oesophageal haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Oesophageal perforation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Oesophageal spasm | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Oesophageal stenosis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Oesophageal ulcer | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Peritonitis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pneumatosis intestinalis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Small intestinal stenosis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Device dislocation | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Drowning | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Feeling abnormal | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Injection site injury | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Biliary sepsis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Biliary tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Perirectal abscess | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Peritonitis bacterial | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Pseudomonas infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Gastroenteritis radiation | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Splenic rupture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Anticoagulation drug level above therapeutic | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypophagia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Brain cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
| |
| Malignant ascites | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
| |
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
| |
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
| |
| Metastases to spine | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
| |
| Akathisia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Coma | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Intracranial pressure increased | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Azotaemia | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Obstructive uropathy | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Gynaecomastia | Reproductive system and breast disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Vein disorder | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Vena cava thrombosis | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
One (1) participant was randomized to the placebo/paclitaxel group but received ramucirumab in error. For ITT population this participant was included in placebo/paclitaxel group and for the Safety population included in the ramucirumab group.
Investigators agreed to delay independently publishing or disclosing data, findings or conclusions from the study except as part of a multi-center publication. Upon study publication or if the draft publication is not produced within approximately 6 months of the final report of the study results, investigators may independently publish, subject to confidential information review/redaction by sponsor. The sponsor may request publication delay up to 90 days to seek patent protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D000230 | Adenocarcinoma |
| 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 |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D000096662 | Ramucirumab |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| 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 |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Other |
|
| United States |
|
| Estonia |
|
| Taiwan |
|
| Spain |
|
| Russia |
|
| Chile |
|
| Italy |
|
| France |
|
| Australia |
|
| South Korea |
|
| Lithuania |
|
| Austria |
|
| United Kingdom |
|
| Hungary |
|
| Mexico |
|
| Argentina |
|
| Poland |
|
| Brazil |
|
| Belgium |
|
| Singapore |
|
| Romania |
|
| Bulgaria |
|
| Germany |
|
| Japan |
|
| Hong Kong |
|
| Israel |
|
Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle. |
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle. |
|
|
|
|
|
|
|