A Study to Evaluate Rivoceranib Plus Best Supportive Care Compared to Placebo Plus Best Supportive Care in Participants With Gastric Cancer (ANGEL)
Gastric Cancer, Gastric Adenocarcinoma
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
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.
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
Experimental
Experimental
Rivoceranib Plus BSC
Placebo
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.