Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy and safety of rivoceranib plus best supportive care (BSC) compared to placebo plus BSC in participants with advanced or metastatic gastric cancer (GC).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rivoceranib Plus BSC | Experimental | Participants will receive rivoceranib 700 milligrams (mg) orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration is 28 days. |
|
| Placebo | Experimental | Participants will receive matching placebo to rivoceranib orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration is 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivoceranib | Drug | Oral tablet |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was defined as the time from randomization to death. Participants alive or lost to follow-up at the end of study (EOS) were censored. | Day 1 (randomization) up to approximately 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | PFS was defined as the time from randomization to either documented radiological progression or death from any cause. Participants alive and free of progression at the EOS were censored. | Up to approximately 24 months |
Not provided
Inclusion Criteria:
Documented primary diagnosis of histologic- or cytologic-confirmed adenocarcinoma of the stomach or gastroesophageal junction.
Locally advanced unresectable or metastatic disease that has progressed since last treatment.
One or more measurable or nonmeasurable evaluable lesions per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Failure or intolerance to at least 2 prior lines of standard chemotherapies with each containing one or more of the following agents:
Disease progression within 6 months after the last treatment.
Adequate bone-marrow, renal and liver function.
Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.
Expected survival of ≥12 weeks, in the opinion of the investigator.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Phoenix | Scottsdale | Arizona | 85259 | United States | ||
| Highlands Oncology Group |
Not provided
Not provided
Not provided
Not provided
Not provided
Participants were randomized to receive either rivoceranib +best supportive care (BSC) or placebo +BSC for approximately 24 months. Participants who benefited from rivoceranib were permitted to continue rivoceranib during an extension period of the study, up to approximately 36 months. Participants in the extension period were followed for survival status only. Only participants whose reason for study discontinuation was death are included. See the AE module for All-Cause Mortality Deaths.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Rivoceranib Plus Best Supportive Care (BSC) | Participants received rivoceranib 700 milligrams (mg) orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration was 28 days. |
| FG001 | Placebo Plus BSC |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Core Phase |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 16, 2018 | May 9, 2022 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Oral tablet |
|
| Objective Response Rate (ORR) Per RECIST 1.1 |
ORR was defined as the percentage of participants in the analysis population with the best overall response of Complete Response (CR: disappearance of all target lesions and reduction in short axis of any nodal target lesions to <10 millimeter [mm]) or a Partial Response (PR: ≥30% decrease in the sum of the longest diameters of the target lesions, taking as a reference the baseline sum diameters) per RECIST 1.1. |
| Up to approximately 24 months |
| Disease Control Rate (DCR) | DCR was defined as the proportion of participants with a Best Overall Response of CR, PR, or stable disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as a reference the smallest sum diameter while on study) per RECIST 1.1. | Up to approximately 24 months |
| Change From Baseline in Global Health Status/Quality of Life (QoL) Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | EORTC QLQ-C30 is a cancer specific Questionnaire with 30 questions for assessing the health-related QOL of cancer participants. The questionnaire incorporates 5 functional scales, 4 symptom scales, a global QOL scale, and single items for the assessment of additional systems commonly reported by cancer participants. All items are scored on 4-point Likert scales, ranging from 1 ('not at all') to 4 ('very much'), with the exception of 2 items in the global QOL scale which use modified 7-point linear analog scales. A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100. For the functioning scales, a higher score indicated greater functioning and for the symptom scales, a higher score indicated a greater symptom burden. | Baseline, End of Treatment (EOT) (Up to 24 months) |
| Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22) Score | EORTC QLQ-STO22 is a 22-item gastric cancer-specific questionnaire-integrating system for assessing the health-related QOL of gastric cancer participants. 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. For the functioning scales, a higher score indicates greater functioning and for the symptom scales, a higher score indicates a greater symptom burden. | Baseline, EOT (Up to 24 months) |
| Change From Baseline in EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS) Score | EQ-5D-5L Questionnaire consists of EQ-5D-5L descriptive system and the visual analogue scale (VAS). The descriptive system comprises the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each dimension has 5 levels. The VAS is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. | Baseline, EOT (Up to 24 months) |
| Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | EQ-5D-5L Questionnaire comprises the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each dimension has 5 levels of response. | EOT (Month 24) |
| Rogers |
| Arkansas |
| 72758 |
| United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| Hudson Valley Cancer Centre | Hawthorne | New York | 10532 | United States |
| Centre Hospitalier Franco-Britannique; Oncologie Médicale | Levallois-Perret | 92300 | France |
| Centre Leon-Berard (CLB) | Lyon | 69008 | France |
| Institut Regional du Cancer Montpellier (ICM) | Montpellier | 34298 | France |
| Centre Antoine-Lacassagne | Nice | 06189 | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| Charite - Universitaetsmedizin Berlin - Medizinische Klinik mit Schwerpunkt Haematologie, Onkologie und Tumorimmunologie | Berlin | 13353 | Germany |
| "Institut für Klinisch-Onkologische Forschung (IKF) Krankenhaus Nordwest gGmbH UCT - Universitäres Centrum für Tumorerkrankungen Frankfurt | Frankfurt | 60488 | Germany |
| Facharztzentrum Eppendorf - Haematologisch-Onkologische Praxis Eppendorf (HOPE) | Hamburg | 20249 | Germany |
| Universitätsklinik Marburg, Klinik fur Innere Medizin, Schwerpunkt Haematologie, Onkologie und Immunologie | Marburg | 35043 | Germany |
| Magna Graecia University- Department of Experimental and Clinical Medicine | Catanzaro | 88100 | Italy |
| U.O Di Oncologia Ospedale Degli Infermi | Faenza | 48018 | Italy |
| Fondazione IRCCS-Istituto Nazionale Tumori | Milan | 20133 | Italy |
| Policlinico di Modena-Azienda Ospedaliero Universitaria di Modena.Oncologia ed Ematologia. | Modena | 41124 | Italy |
| Veneto Oncology Institute (IOV-IRCCS), Melanoma & Esophageal Oncology Unit | Padova | 35128 | Italy |
| Ospedale di Piacenza - Oncology and heamatology | Piacenza | 29121 | Italy |
| Ospedale "Felice Lotti" | Pontedera | 56025 | Italy |
| IRCCS/Arcispedale Santa Maria Nuova | Reggio Emilia | 42123 | Italy |
| Rimini Hospital | Rimini | 47923 | Italy |
| Ospedali Riuniti di Ancona - SOD Clinica Oncologica | Torrette | 60126 | Italy |
| Hyogo Cancer Center | Hyōgo | Akasi-city | 673-0021 | Japan |
| Chiba Cancer Center | Chiba | Chiba City | 260-8717 | Japan |
| National Cancer Center Hospital | Tokyo | Chuo-ku | 104-0045 | Japan |
| Kyushu University Hospital | Fukuoka | Higashi-ku | 812-8582 | Japan |
| National Cancer Center Hospital East | Chiba | Kashiwa | 277-8577 | Japan |
| St. Marianna University School of Medicine Hospital | Kanagawa | Kawasaki-shi | 216-8511 | Japan |
| Saitama Cancer Center | Saitama | Kitaadachi-gun | 362-0806 | Japan |
| Japan Community Health Care Organization Kyushu Hospital | Fukuoka | Kitakyushu-shi | 806-8501 | Japan |
| The Cancer Institute Hospital of Japanese Foundation For Cancer Research | Tokyo | Koto-ku | 135-8550 | Japan |
| National Hospital Organization Shikoku Cancer Center | Ehime | Matsuyama | 791-0280 | Japan |
| Saku Central Hospital Advanced Care Center | Nagano | Saku-shi | 385-0051 | Japan |
| Hokkaido University Hospital | Hokkaido | Sapporo | 060-8648 | Japan |
| Keio University Hospital | Tokyo | Shinjuku-ku | 160-8582 | Japan |
| Osaka University Hospital | Osaka | Suita | 565-0871 | Japan |
| Aichi Cancer Center Hospital | Nagoya | 464-8681 | Japan |
| Szpital Uniwersytecki w Krakowie, Odział Kliniczny Onkologii | Krakow | 31-501 | Poland |
| Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie, Klinika Gastroenterologii Onkologicznej | Warsaw | 02-781 | Poland |
| Saint Constantin Hospital (TEO HEALTH SA) | Brasov | 500091 | Romania |
| Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca, Sectia de Radioterapie I | Cluj-Napoca | 400015 | Romania |
| S.C. Medisprof S.R.L. | Cluj-Napoca | 400058 | Romania |
| Centrul de Oncologie "Sf. Nectarie", Sectia de Oncologie Medicala | Craiova | 200347 | Romania |
| State Budgetary Healthcare Institution of Arkhangelsk Region "Arkhangelsk Clinical Oncology Dispensary" | Arkhangelsk | 163045 | Russia |
| State Healthcare Institution "Kursk Regional Clinical Oncology Dispensary" | Kursk | 305035 | Russia |
| Omsk regional clinical oncology center | Omsk | 644013 | Russia |
| Budgetary Healthcare Institution of Orel Region "Orel Oncology Dispensary" | Oryol | 302020 | Russia |
| State Budgetary Healthcare Institution of Stavropol Territory "Pyatigorsk Oncology Dispensary" | Pyatigorsk | 357502 | Russia |
| Federal State Budgetary Educational Institution of Higher Education "Academician I.P. Pavlov First St. Petersburg State Medical University" of the Ministry of Heaithcare of the Russian Federation | Saint Petersburg | 197022 | Russia |
| Ogarev Mordovia State University | Saransk | 430032 | Russia |
| State Budgetary Healthcare Institution "Republican Clinical Oncology Dispensary" | Ufa | 450054 | Russia |
| Hallym University Sacred Heart Hospital | Anyang-si | Gyeonggi-do | 14069 | South Korea |
| National Cancer Center | Goyang-si | Gyeonggi-do | 10408 | South Korea |
| Ajou University Hospital | Suwon | Gyonggi-do | 16499 | South Korea |
| Inje University Haeundae Paik Hospital | Busan | 48108 | South Korea |
| Dong-A University Hospital | Busan | 49201 | South Korea |
| Pusan National University Hospital | Busan | 49241 | South Korea |
| Chungbuk National University Medical Center | Chuncheon | 41404 | South Korea |
| Kyungpook National University Medical Center | Daegu | 41404 | South Korea |
| Keimyung University Dongsan Medical Center | Daegu | 41931 | South Korea |
| Yeungnam University Medical Center | Daegu | 42415 | South Korea |
| Chungnam National University Hospital | Daejeon | 35015 | South Korea |
| Seoul National University Bundang Hospital | Gyeonggi-do | 13620 | South Korea |
| Gachon University Gil Medical Center | Incheon | 21555 | South Korea |
| Korea University Anam Hospital | Seoul | 02841 | South Korea |
| Severence Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Veterans Health Service (VHS) Medical Center | Seoul | 05368 | South Korea |
| ASAN Medical Center | Seoul | 05505 | South Korea |
| Gangnam Severance Hospital | Seoul | 06273 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Korea University Guro Hospital | Seoul | 08308 | South Korea |
| Chungbuk National University Hospital | Taebuk | 54907 | South Korea |
| Ulsan University Hospital | Ulsan | 44033 | South Korea |
| Taipei Veterans General Hospital | Taipei | Beitou Dist | 11217 | Taiwan |
| Chang Gung Memorial Hospital - Linko Branch | Taoyuan | Kuei Shan Hsiang | 333 | Taiwan |
| Chi Mei Medical Center - LiouYing Branch | Tainan | Liuying DIst | 736 | Taiwan |
| Chang Gung Memorial Hospital - Kaohsiung Branch | Kaohsiung City | Niaosong Dist | 83301 | Taiwan |
| Kaohsiung Medical University Hospital | Kaohsiung City | Sanmin Dist | 80708 | Taiwan |
| China Medical University Hospital | Taichung | Taichung City | 40447 | Taiwan |
| National CHeng Kung University Hospital | Tainan | Tainan City | 70403 | Taiwan |
| National Taiwan University Hospital | Taipei | Zhongzheng Dist | 100 | Taiwan |
| Dnipropetrovsk Medical Academy, Department of Oncology | Dnipro | 49102 | Ukraine |
| Communal Institution "Ivano-Frankivsk Regional Oncological Center" | Ivano-Frankivsk | 76000 | Ukraine |
| Communal Institution "Kharkiv Regional Clinical Oncology Center ", Chemotherapy department #1, Medical Academy of Postgraduate Education, Oncology and Pediatric Oncology | Kharkiv | 61070 | Ukraine |
| Kherson Regional Oncological Dispensary | Kherson | 73035 | Ukraine |
| Municipal Institution Kryvyi Rig Oncology Dispensary", Chemotherapy Department | Kryvyi Rih | 50048 | Ukraine |
| Municipal Institution "Kyiv City Clinical Oncological Center" | Kyiv | 03115 | Ukraine |
| Communal Institution "Transcarpathian Regional Clinical Oncological Center" | Uzhhorod | 88014 | Ukraine |
| Communal Institution "Vinnytsia Regional Clinical Oncology Dispensary" | Vinnytsia | 21029 | Ukraine |
| State institution "Zaporizhzhia Medical Academy of Postgraduate Education MOH Ukraine", Department of oncology based on Municipal Institution "Zaporizhzhia Regional Clinical Oncology Dispensary" Zaporizhzhia Regional Assembly | Zaporizhzhia | 69040 | Ukraine |
| Royal Marsden Hospital London | London | SW3 6JJ | United Kingdom |
| The Christie NHS Foundation Trust | Manchester | M20 4BX | United Kingdom |
| Royal Marsden Hospital Surrey | Sutton | SM2 5PT | United Kingdom |
Participants received matching placebo to rivoceranib orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration was 28 days. |
| FG002 | Extension Phase: Rivoceranib Plus BSC | Participants received rivoceranib 700 mg orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration was 28 days. |
| FG003 | Extension Phase: Placebo Plus BSC | Participants received matching placebo to rivoceranib orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration was 28 days. |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Extension Phase |
|
|
The Intent to Treat (ITT) set consists of data from all participants who were randomized. In the ITT set, participants were included in the group to which they were randomized.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Rivoceranib Plus Best Supportive Care (BSC) | Participants received rivoceranib 700 milligrams (mg) orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration was 28 days. |
| BG001 | Placebo Plus BSC | Participants received matching placebo to rivoceranib orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration was 28 days. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | 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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Survival (OS) | OS was defined as the time from randomization to death. Participants alive or lost to follow-up at the end of study (EOS) were censored. | The ITT set for the OS final analysis consisted of data from all participants who were randomized, including participants who were still in OS follow-up at the time of primary analysis. In the ITT set, participants were included in the group to which they were randomized. | Posted | Median | 95% Confidence Interval | Months | Day 1 (randomization) up to approximately 36 months |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | PFS was defined as the time from randomization to either documented radiological progression or death from any cause. Participants alive and free of progression at the EOS were censored. | The ITT set consisted of data from all participants who were randomized. In the ITT set, participants were included in the group to which they were randomized. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 24 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) Per RECIST 1.1 | ORR was defined as the percentage of participants in the analysis population with the best overall response of Complete Response (CR: disappearance of all target lesions and reduction in short axis of any nodal target lesions to <10 millimeter [mm]) or a Partial Response (PR: ≥30% decrease in the sum of the longest diameters of the target lesions, taking as a reference the baseline sum diameters) per RECIST 1.1. | The ITT set consisted of data from all participants who were randomized. In the ITT set, participants were included in the group to which they were randomized. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 24 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) | DCR was defined as the proportion of participants with a Best Overall Response of CR, PR, or stable disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as a reference the smallest sum diameter while on study) per RECIST 1.1. | The ITT set consisted of data from all participants who were randomized. In the ITT set, participants were included in the group to which they were randomized. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 24 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Global Health Status/Quality of Life (QoL) Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | EORTC QLQ-C30 is a cancer specific Questionnaire with 30 questions for assessing the health-related QOL of cancer participants. The questionnaire incorporates 5 functional scales, 4 symptom scales, a global QOL scale, and single items for the assessment of additional systems commonly reported by cancer participants. All items are scored on 4-point Likert scales, ranging from 1 ('not at all') to 4 ('very much'), with the exception of 2 items in the global QOL scale which use modified 7-point linear analog scales. A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100. For the functioning scales, a higher score indicated greater functioning and for the symptom scales, a higher score indicated a greater symptom burden. | The ITT set consisted of data from all participants who were randomized. In the ITT set, participants were included in the group to which they were randomized. Overall number of participants indicates total number of participants with evaluable data. | Posted | Mean | Standard Deviation | units on a scale | Baseline, End of Treatment (EOT) (Up to 24 months) |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22) Score | EORTC QLQ-STO22 is a 22-item gastric cancer-specific questionnaire-integrating system for assessing the health-related QOL of gastric cancer participants. 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. For the functioning scales, a higher score indicates greater functioning and for the symptom scales, a higher score indicates a greater symptom burden. | The ITT set consisted of data from all participants who were randomized. In the ITT set, participants were included in the group to which they were randomized. Overall number of participants indicates total at baseline, number of participants analyzed indicates number of participants with evaluable data. | Posted | Mean | Standard Deviation | units on a scale | Baseline, EOT (Up to 24 months) |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS) Score | EQ-5D-5L Questionnaire consists of EQ-5D-5L descriptive system and the visual analogue scale (VAS). The descriptive system comprises the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each dimension has 5 levels. The VAS is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. | The ITT set consisted of data from all participants who were randomized. In the ITT set, participants were included in the group to which they were randomized. Overall number of participants indicates total number of participants with evaluable data. | Posted | Mean | Standard Deviation | units on a scale | Baseline, EOT (Up to 24 months) |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | EQ-5D-5L Questionnaire comprises the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each dimension has 5 levels of response. | The ITT set consisted of data from all participants who were randomized. In the ITT set, participants were included in the group to which they were randomized. Overall number of participants indicates total at baseline. | Posted | Count of Participants | Participants | EOT (Month 24) |
|
|
Up to approximately 36 months
The Safety set consisted of data from all participants in the ITT set who received at least 1 dose of rivoceranib or placebo. In the Safety set, participants were included in the group based on the treatment that was received. Safety data was analyzed by the Safety set which includes participants who were alive and on treatment or in OS follow-up. All-Cause Mortality includes deaths that led to study discontinuation and deaths that occurred during safety follow up.
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 | Rivoceranib Plus Best Supportive Care (BSC) | Participants received rivoceranib 700 mg orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration was 28 days. | 283 | 307 | 149 | 307 | 299 | 307 |
| EG001 | Placebo Plus BSC | Participants received matching placebo to rivoceranib orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration was 28 days. | 134 | 151 | 66 | 151 | 140 | 151 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Obstruction gastric | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Gastric perforation | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Gastric stenosis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Mechanical ileus | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Acute abdomen | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Intestinal infarction | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Malignant dysphagia | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Oesophageal pain | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Oesophageal perforation | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Oesophageal stenosis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Volvulus | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Biliary dilatation | Hepatobiliary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Bile duct stenosis | Hepatobiliary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cholangitis acute | Hepatobiliary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Biliary sepsis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Biliary tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Endophthalmitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Urethritis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypophagia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Posterior reversible encephalopathy syndrome | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Nephropathy toxic | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cardiac ventricular thrombosis | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Intestinal anastomosis complication | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Radiation mucositis | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Delusion | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Device malfunction | Product Issues | MedDRA 21.0 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Central venous catheter removal | Surgical and medical procedures | MedDRA 21.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elevar Clinical Trials | Elevar Therapeutics, Inc | (801) 303-7440 | info-clinicalstudy@elevartherapeutics.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 1, 2019 | May 9, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D009369 | Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C553458 | apatinib |
Not provided
Not provided
Not provided
| Lost to Follow-up |
|
| Study Closed |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Participants |
|
|
|
| Placebo Plus BSC |
Participants received matching placebo to rivoceranib orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration was 28 days. |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|