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A Study to Evaluate Rivoceranib Plus Best Supportive Care Compared to Placebo Plus Best Supportive Care in Participants With Gastric Cancer (ANGEL)

Primary Purpose

Gastric Cancer, Gastric Adenocarcinoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rivoceranib
Placebo
Sponsored by
Elevar Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric Cancer, Gastric Adenocarcinoma, Gastro-esophageal Cancer, Gastro-esophageal Junction Cancer, Stomach Cancer, Tumor, Oncology, Antiangiogenesis, Metastatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Documented primary diagnosis of histologic- or cytologic-confirmed adenocarcinoma of the stomach or gastroesophageal junction.
  2. Locally advanced unresectable or metastatic disease that has progressed since last treatment.
  3. One or more measurable or nonmeasurable evaluable lesions per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).

  4. Failure or intolerance to at least 2 prior lines of standard chemotherapies with each containing one or more of the following agents:

    • fluoropyrimidine (intravenous [IV] 5-fluorouracil [5-FU] capecitabine, or S-1),
    • platinum (cisplatin or oxaliplatin),
    • taxanes (paclitaxel or docetaxel) or epirubicin,
    • irinotecan,
    • trastuzumab in case of human epidermal growth factor receptor 2 (HER2)-positive,
    • ramucirumab
    • nivolumab
    • pembrolizumab
  5. Disease progression within 6 months after the last treatment.
  6. Adequate bone-marrow, renal and liver function.
  7. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.
  8. Expected survival of ≥12 weeks, in the opinion of the investigator.

Exclusion Criteria:

  1. History of another malignancy within 2 years prior to randomization except for the following: Bladder tumors considered superficial such as noninvasive (T1a) and carcinoma in situ (CIS); Curatively treated cervical CIS; Thyroid papillary cancer with prior treatment; Carcinoma of the skin without melanomatous features; Prostate cancer which had been surgically or medically treated and not likely to recur within 2 years.
  2. Central nervous system (CNS) metastases as shown by radiology records or clinical evidence of symptomatic CNS involvement in the last 3 months prior to randomization.
  3. Cytotoxic chemotherapy, surgery, immunotherapy, radiotherapy or other targeted therapies within 3 weeks (4 weeks in cases of ramucirumab, mitomycin C, nitrosourea, lomustine; 1 week in case of biopsy) prior to randomization (Adjuvant radiotherapy given to local area for non-curative symptom relief is allowed until 2 weeks before randomization.).
  4. Therapy with clinically significant systemic anticoagulant or antithrombotic agents within 7 days prior to randomization that may prevent blood clotting and, in the investigator's opinion, could place the participant at risk.
  5. Participants who had therapeutic paracentesis of ascites (>1 Liter [L]) within the 3 months prior to starting study treatment or who, in the opinion of the investigator, will likely need therapeutic paracentesis of ascites (>1L) within 3 months of starting study treatment.
  6. Previous treatment with rivoceranib.
  7. Known hypersensitivity to rivoceranib or components of the formulation.
  8. Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9, and CYP2C19.

Sites / Locations

  • Mayo Clinic Phoenix
  • Highlands Oncology Group
  • Karmanos Cancer Institute
  • Mayo Clinic Cancer Center
  • Hudson Valley Cancer Centre
  • Centre Hospitalier Franco-Britannique; Oncologie Médicale
  • Centre Leon-Berard (CLB)
  • Institut Regional du Cancer Montpellier (ICM)
  • Centre Antoine-Lacassagne
  • Institut Gustave Roussy
  • Charite - Universitaetsmedizin Berlin - Medizinische Klinik mit Schwerpunkt Haematologie, Onkologie und Tumorimmunologie
  • "Institut für Klinisch-Onkologische Forschung (IKF) Krankenhaus Nordwest gGmbH UCT - Universitäres Centrum für Tumorerkrankungen Frankfurt
  • Facharztzentrum Eppendorf - Haematologisch-Onkologische Praxis Eppendorf (HOPE)
  • Universitätsklinik Marburg, Klinik fur Innere Medizin, Schwerpunkt Haematologie, Onkologie und Immunologie
  • Magna Graecia University- Department of Experimental and Clinical Medicine
  • U.O Di Oncologia Ospedale Degli Infermi
  • Fondazione IRCCS-Istituto Nazionale Tumori
  • Policlinico di Modena-Azienda Ospedaliero Universitaria di Modena.Oncologia ed Ematologia.
  • Veneto Oncology Institute (IOV-IRCCS), Melanoma & Esophageal Oncology Unit
  • Ospedale di Piacenza - Oncology and heamatology
  • Ospedale "Felice Lotti"
  • IRCCS/Arcispedale Santa Maria Nuova
  • Rimini Hospital
  • Ospedali Riuniti di Ancona - SOD Clinica Oncologica
  • Hyogo Cancer Center
  • Chiba Cancer Center
  • National Cancer Center Hospital
  • Kyushu University Hospital
  • National Cancer Center Hospital East
  • St. Marianna University School of Medicine Hospital
  • Saitama Cancer Center
  • Japan Community Health Care Organization Kyushu Hospital
  • The Cancer Institute Hospital of Japanese Foundation For Cancer Research
  • National Hospital Organization Shikoku Cancer Center
  • Saku Central Hospital Advanced Care Center
  • Hokkaido University Hospital
  • Keio University Hospital
  • Osaka University Hospital
  • Aichi Cancer Center Hospital
  • Hallym University Sacred Heart Hospital
  • National Cancer Center
  • Ajou University Hospital
  • Inje University Haeundae Paik Hospital
  • Dong-A University Hospital
  • Pusan National University Hospital
  • Chungbuk National University Medical Center
  • Chungbuk National University Hospital
  • Kyungpook National University Medical Center
  • Keimyung University Dongsan Medical Center
  • Yeungnam University Medical Center
  • Chungnam National University Hospital
  • Seoul National University Bundang Hospital
  • Gachon University Gil Medical Center
  • Korea University Anam Hospital
  • Severence Hospital, Yonsei University Health System
  • Veterans Health Service (VHS) Medical Center
  • ASAN Medical Center
  • Gangnam Severance Hospital
  • Samsung Medical Center
  • Korea University Guro Hospital
  • Ulsan University Hospital
  • Szpital Uniwersytecki w Krakowie, Odział Kliniczny Onkologii
  • Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie, Klinika Gastroenterologii Onkologicznej
  • Saint Constantin Hospital (TEO HEALTH SA)
  • Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca, Sectia de Radioterapie I
  • S.C. Medisprof S.R.L.
  • Centrul de Oncologie "Sf. Nectarie", Sectia de Oncologie Medicala
  • State Budgetary Healthcare Institution of Arkhangelsk Region "Arkhangelsk Clinical Oncology Dispensary"
  • State Healthcare Institution "Kursk Regional Clinical Oncology Dispensary"
  • Omsk regional clinical oncology center
  • Budgetary Healthcare Institution of Orel Region "Orel Oncology Dispensary"
  • State Budgetary Healthcare Institution of Stavropol Territory "Pyatigorsk Oncology Dispensary"
  • Ogarev Mordovia State University
  • 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
  • State Budgetary Healthcare Institution "Republican Clinical Oncology Dispensary"
  • Taipei Veterans General Hospital
  • Chang Gung Memorial Hospital - Linko Branch
  • Chi Mei Medical Center - LiouYing Branch
  • Chang Gung Memorial Hospital - Kaohsiung Branch
  • Kaohsiung Medical University Hospital
  • China Medical University Hospital
  • National CHeng Kung University Hospital
  • National Taiwan University Hospital
  • Dnipropetrovsk Medical Academy, Department of Oncology
  • Communal Institution "Ivano-Frankivsk Regional Oncological Center"
  • Communal Institution "Kharkiv Regional Clinical Oncology Center ", Chemotherapy department #1, Medical Academy of Postgraduate Education, Oncology and Pediatric Oncology
  • Kherson Regional Oncological Dispensary
  • Municipal Institution Kryvyi Rig Oncology Dispensary", Chemotherapy Department
  • Municipal Institution "Kyiv City Clinical Oncological Center"
  • Communal Institution "Transcarpathian Regional Clinical Oncological Center"
  • Communal Institution "Vinnytsia Regional Clinical Oncology Dispensary"
  • 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
  • Royal Marsden Hospital London
  • The Christie NHS Foundation Trust
  • Royal Marsden Hospital Surrey

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Rivoceranib Plus BSC

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
January 24, 2017
Last Updated
June 15, 2022
Sponsor
Elevar Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT03042611
Brief Title
A Study to Evaluate Rivoceranib Plus Best Supportive Care Compared to Placebo Plus Best Supportive Care in Participants With Gastric Cancer
Acronym
ANGEL
Official Title
A Prospective, Randomized, Double-Blinded, Placebo-Controlled, Multinational, Multicenter, Parallel-group, Phase III Study to Evaluate the Efficacy and Safety of Apatinib Plus Best Supportive Care (BSC) Compared to Placebo Plus BSC in Patients With Advanced or Metastatic Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
March 14, 2017 (Actual)
Primary Completion Date
February 15, 2019 (Actual)
Study Completion Date
September 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Elevar Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Gastric Adenocarcinoma
Keywords
Gastric Cancer, Gastric Adenocarcinoma, Gastro-esophageal Cancer, Gastro-esophageal Junction Cancer, Stomach Cancer, Tumor, Oncology, Antiangiogenesis, Metastatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
460 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rivoceranib Plus BSC
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Rivoceranib
Other Intervention Name(s)
Apatinib
Intervention Description
Oral tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral tablet
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
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.
Time Frame
Day 1 (randomization) up to approximately 36 months
Secondary Outcome Measure Information:
Title
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Description
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.
Time Frame
Up to approximately 24 months
Title
Objective Response Rate (ORR) Per RECIST 1.1
Description
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.
Time Frame
Up to approximately 24 months
Title
Disease Control Rate (DCR)
Description
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.
Time Frame
Up to approximately 24 months
Title
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)
Description
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.
Time Frame
Baseline, End of Treatment (EOT) (Up to 24 months)
Title
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22) Score
Description
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.
Time Frame
Baseline, EOT (Up to 24 months)
Title
Change From Baseline in EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS) Score
Description
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.
Time Frame
Baseline, EOT (Up to 24 months)
Title
Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire
Description
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.
Time Frame
EOT (Month 24)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: fluoropyrimidine (intravenous [IV] 5-fluorouracil [5-FU] capecitabine, or S-1), platinum (cisplatin or oxaliplatin), taxanes (paclitaxel or docetaxel) or epirubicin, irinotecan, trastuzumab in case of human epidermal growth factor receptor 2 (HER2)-positive, ramucirumab nivolumab pembrolizumab 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: History of another malignancy within 2 years prior to randomization except for the following: Bladder tumors considered superficial such as noninvasive (T1a) and carcinoma in situ (CIS); Curatively treated cervical CIS; Thyroid papillary cancer with prior treatment; Carcinoma of the skin without melanomatous features; Prostate cancer which had been surgically or medically treated and not likely to recur within 2 years. Central nervous system (CNS) metastases as shown by radiology records or clinical evidence of symptomatic CNS involvement in the last 3 months prior to randomization. Cytotoxic chemotherapy, surgery, immunotherapy, radiotherapy or other targeted therapies within 3 weeks (4 weeks in cases of ramucirumab, mitomycin C, nitrosourea, lomustine; 1 week in case of biopsy) prior to randomization (Adjuvant radiotherapy given to local area for non-curative symptom relief is allowed until 2 weeks before randomization.). Therapy with clinically significant systemic anticoagulant or antithrombotic agents within 7 days prior to randomization that may prevent blood clotting and, in the investigator's opinion, could place the participant at risk. Participants who had therapeutic paracentesis of ascites (>1 Liter [L]) within the 3 months prior to starting study treatment or who, in the opinion of the investigator, will likely need therapeutic paracentesis of ascites (>1L) within 3 months of starting study treatment. Previous treatment with rivoceranib. Known hypersensitivity to rivoceranib or components of the formulation. Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9, and CYP2C19.
Facility Information:
Facility Name
Mayo Clinic Phoenix
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Highlands Oncology Group
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Hudson Valley Cancer Centre
City
Hawthorne
State/Province
New York
ZIP/Postal Code
10532
Country
United States
Facility Name
Centre Hospitalier Franco-Britannique; Oncologie Médicale
City
Levallois-Perret
ZIP/Postal Code
92300
Country
France
Facility Name
Centre Leon-Berard (CLB)
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Institut Regional du Cancer Montpellier (ICM)
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Centre Antoine-Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Charite - Universitaetsmedizin Berlin - Medizinische Klinik mit Schwerpunkt Haematologie, Onkologie und Tumorimmunologie
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
"Institut für Klinisch-Onkologische Forschung (IKF) Krankenhaus Nordwest gGmbH UCT - Universitäres Centrum für Tumorerkrankungen Frankfurt
City
Frankfurt
ZIP/Postal Code
60488
Country
Germany
Facility Name
Facharztzentrum Eppendorf - Haematologisch-Onkologische Praxis Eppendorf (HOPE)
City
Hamburg
ZIP/Postal Code
20249
Country
Germany
Facility Name
Universitätsklinik Marburg, Klinik fur Innere Medizin, Schwerpunkt Haematologie, Onkologie und Immunologie
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Name
Magna Graecia University- Department of Experimental and Clinical Medicine
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
U.O Di Oncologia Ospedale Degli Infermi
City
Faenza
ZIP/Postal Code
48018
Country
Italy
Facility Name
Fondazione IRCCS-Istituto Nazionale Tumori
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Policlinico di Modena-Azienda Ospedaliero Universitaria di Modena.Oncologia ed Ematologia.
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
Veneto Oncology Institute (IOV-IRCCS), Melanoma & Esophageal Oncology Unit
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Ospedale di Piacenza - Oncology and heamatology
City
Piacenza
ZIP/Postal Code
29121
Country
Italy
Facility Name
Ospedale "Felice Lotti"
City
Pontedera
ZIP/Postal Code
56025
Country
Italy
Facility Name
IRCCS/Arcispedale Santa Maria Nuova
City
Reggio Emilia
ZIP/Postal Code
42123
Country
Italy
Facility Name
Rimini Hospital
City
Rimini
ZIP/Postal Code
47923
Country
Italy
Facility Name
Ospedali Riuniti di Ancona - SOD Clinica Oncologica
City
Torrette
ZIP/Postal Code
60126
Country
Italy
Facility Name
Hyogo Cancer Center
City
Hyogo
State/Province
Akasi-city
ZIP/Postal Code
673-0021
Country
Japan
Facility Name
Chiba Cancer Center
City
Chiba
State/Province
Chiba City
ZIP/Postal Code
260-8717
Country
Japan
Facility Name
National Cancer Center Hospital
City
Tokyo
State/Province
Chuo-ku
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Kyushu University Hospital
City
Fukuoka
State/Province
Higashi-ku
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
National Cancer Center Hospital East
City
Chiba
State/Province
Kashiwa
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
St. Marianna University School of Medicine Hospital
City
Kanagawa
State/Province
Kawasaki-shi
ZIP/Postal Code
216-8511
Country
Japan
Facility Name
Saitama Cancer Center
City
Saitama
State/Province
Kitaadachi-gun
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
Japan Community Health Care Organization Kyushu Hospital
City
Fukuoka
State/Province
Kitakyushu-shi
ZIP/Postal Code
806-8501
Country
Japan
Facility Name
The Cancer Institute Hospital of Japanese Foundation For Cancer Research
City
Tokyo
State/Province
Koto-ku
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
National Hospital Organization Shikoku Cancer Center
City
Ehime
State/Province
Matsuyama
ZIP/Postal Code
791-0280
Country
Japan
Facility Name
Saku Central Hospital Advanced Care Center
City
Nagano
State/Province
Saku-shi
ZIP/Postal Code
385-0051
Country
Japan
Facility Name
Hokkaido University Hospital
City
Hokkaido
State/Province
Sapporo
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Keio University Hospital
City
Tokyo
State/Province
Shinjuku-ku
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Osaka University Hospital
City
Osaka
State/Province
Suita
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Aichi Cancer Center Hospital
City
Nagoya
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Hallym University Sacred Heart Hospital
City
Anyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
14069
Country
Korea, Republic of
Facility Name
National Cancer Center
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Suwon-si
State/Province
Gyonggi-do
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
Inje University Haeundae Paik Hospital
City
Busan
ZIP/Postal Code
48108
Country
Korea, Republic of
Facility Name
Dong-A University Hospital
City
Busan
ZIP/Postal Code
49201
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Chungbuk National University Medical Center
City
Chuncheon
ZIP/Postal Code
41404
Country
Korea, Republic of
Facility Name
Chungbuk National University Hospital
City
Chungbuk
ZIP/Postal Code
54907
Country
Korea, Republic of
Facility Name
Kyungpook National University Medical Center
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
ZIP/Postal Code
41931
Country
Korea, Republic of
Facility Name
Yeungnam University Medical Center
City
Daegu
ZIP/Postal Code
42415
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejeon
ZIP/Postal Code
35015
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
21555
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Severence Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Veterans Health Service (VHS) Medical Center
City
Seoul
ZIP/Postal Code
05368
Country
Korea, Republic of
Facility Name
ASAN Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Gangnam Severance Hospital
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
Ulsan University Hospital
City
Ulsan
ZIP/Postal Code
44033
Country
Korea, Republic of
Facility Name
Szpital Uniwersytecki w Krakowie, Odział Kliniczny Onkologii
City
Kraków
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie, Klinika Gastroenterologii Onkologicznej
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Saint Constantin Hospital (TEO HEALTH SA)
City
Brasov
ZIP/Postal Code
500091
Country
Romania
Facility Name
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca, Sectia de Radioterapie I
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
S.C. Medisprof S.R.L.
City
Cluj-Napoca
ZIP/Postal Code
400058
Country
Romania
Facility Name
Centrul de Oncologie "Sf. Nectarie", Sectia de Oncologie Medicala
City
Craiova
ZIP/Postal Code
200347
Country
Romania
Facility Name
State Budgetary Healthcare Institution of Arkhangelsk Region "Arkhangelsk Clinical Oncology Dispensary"
City
Arkhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
State Healthcare Institution "Kursk Regional Clinical Oncology Dispensary"
City
Kursk
ZIP/Postal Code
305035
Country
Russian Federation
Facility Name
Omsk regional clinical oncology center
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
Budgetary Healthcare Institution of Orel Region "Orel Oncology Dispensary"
City
Oryol
ZIP/Postal Code
302020
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution of Stavropol Territory "Pyatigorsk Oncology Dispensary"
City
Pyatigorsk
ZIP/Postal Code
357502
Country
Russian Federation
Facility Name
Ogarev Mordovia State University
City
Saransk
ZIP/Postal Code
430032
Country
Russian Federation
Facility Name
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
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution "Republican Clinical Oncology Dispensary"
City
Ufa
ZIP/Postal Code
450054
Country
Russian Federation
Facility Name
Taipei Veterans General Hospital
City
Taipei
State/Province
Beitou Dist
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital - Linko Branch
City
Taoyuan
State/Province
Kuei Shan Hsiang
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Chi Mei Medical Center - LiouYing Branch
City
Tainan
State/Province
Liuying DIst
ZIP/Postal Code
736
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital - Kaohsiung Branch
City
Kaohsiung
State/Province
Niaosong Dist
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Kaohsiung Medical University Hospital
City
Kaohsiung
State/Province
Sanmin Dist
ZIP/Postal Code
80708
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
State/Province
Taichung City
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National CHeng Kung University Hospital
City
Tainan
State/Province
Tainan City
ZIP/Postal Code
70403
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
State/Province
Zhongzheng Dist
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Dnipropetrovsk Medical Academy, Department of Oncology
City
Dnipro
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Communal Institution "Ivano-Frankivsk Regional Oncological Center"
City
Ivano-Frankivsk
ZIP/Postal Code
76000
Country
Ukraine
Facility Name
Communal Institution "Kharkiv Regional Clinical Oncology Center ", Chemotherapy department #1, Medical Academy of Postgraduate Education, Oncology and Pediatric Oncology
City
Kharkiv
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
Kherson Regional Oncological Dispensary
City
Kherson
ZIP/Postal Code
73035
Country
Ukraine
Facility Name
Municipal Institution Kryvyi Rig Oncology Dispensary", Chemotherapy Department
City
Kryvyi Rih
ZIP/Postal Code
50048
Country
Ukraine
Facility Name
Municipal Institution "Kyiv City Clinical Oncological Center"
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Communal Institution "Transcarpathian Regional Clinical Oncological Center"
City
Uzhhorod
ZIP/Postal Code
88014
Country
Ukraine
Facility Name
Communal Institution "Vinnytsia Regional Clinical Oncology Dispensary"
City
Vinnytsia
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
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
City
Zaporizhzhia
ZIP/Postal Code
69040
Country
Ukraine
Facility Name
Royal Marsden Hospital London
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Royal Marsden Hospital Surrey
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study to Evaluate Rivoceranib Plus Best Supportive Care Compared to Placebo Plus Best Supportive Care in Participants With Gastric Cancer

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