Esophageal Cancer Clinical Trial

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

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).

View Eligibility Criteria

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.

Study is for people with:

Esophageal Cancer

Phase:

Phase 3

Estimated Enrollment:

460

Study ID:

NCT03042611

Recruitment Status:

Completed

Sponsor:

Elevar Therapeutics

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There are 94 Locations for this study

See Locations Near You

Mayo Clinic Phoenix
Scottsdale Arizona, 85259, United States
Highlands Oncology Group
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
Milano , 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
Hyogo Akasi-city, 673-0, Japan
Chiba Cancer Center
Chiba Chiba City, 260-8, Japan
National Cancer Center Hospital
Tokyo Chuo-ku, 104-0, Japan
Kyushu University Hospital
Fukuoka Higashi-ku, 812-8, Japan
National Cancer Center Hospital East
Chiba Kashiwa, 277-8, Japan
St. Marianna University School of Medicine Hospital
Kanagawa Kawasaki-shi, 216-8, Japan
Saitama Cancer Center
Saitama Kitaadachi-gun, 362-0, Japan
Japan Community Health Care Organization Kyushu Hospital
Fukuoka Kitakyushu-shi, 806-8, Japan
The Cancer Institute Hospital of Japanese Foundation For Cancer Research
Tokyo Koto-ku, 135-8, Japan
National Hospital Organization Shikoku Cancer Center
Ehime Matsuyama, 791-0, Japan
Saku Central Hospital Advanced Care Center
Nagano Saku-shi, 385-0, Japan
Hokkaido University Hospital
Hokkaido Sapporo, 060-8, Japan
Keio University Hospital
Tokyo Shinjuku-ku, 160-8, Japan
Osaka University Hospital
Osaka Suita, 565-0, Japan
Aichi Cancer Center Hospital
Nagoya , 464-8, Japan
Hallym University Sacred Heart Hospital
Anyang-si Gyeonggi-do, 14069, Korea, Republic of
National Cancer Center
Goyang-si Gyeonggi-do, 10408, Korea, Republic of
Ajou University Hospital
Suwon-si Gyonggi-do, 16499, Korea, Republic of
Inje University Haeundae Paik Hospital
Busan , 48108, Korea, Republic of
Dong-A University Hospital
Busan , 49201, Korea, Republic of
Pusan National University Hospital
Busan , 49241, Korea, Republic of
Chungbuk National University Medical Center
Chuncheon , 41404, Korea, Republic of
Chungbuk National University Hospital
Chungbuk , 54907, Korea, Republic of
Kyungpook National University Medical Center
Daegu , 41404, Korea, Republic of
Keimyung University Dongsan Medical Center
Daegu , 41931, Korea, Republic of
Yeungnam University Medical Center
Daegu , 42415, Korea, Republic of
Chungnam National University Hospital
Daejeon , 35015, Korea, Republic of
Seoul National University Bundang Hospital
Gyeonggi-do , 13620, Korea, Republic of
Gachon University Gil Medical Center
Incheon , 21555, Korea, Republic of
Korea University Anam Hospital
Seoul , 02841, Korea, Republic of
Severence Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Veterans Health Service (VHS) Medical Center
Seoul , 05368, Korea, Republic of
ASAN Medical Center
Seoul , 05505, Korea, Republic of
Gangnam Severance Hospital
Seoul , 06273, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
Korea University Guro Hospital
Seoul , 08308, Korea, Republic of
Ulsan University Hospital
Ulsan , 44033, Korea, Republic of
Szpital Uniwersytecki w Krakowie, Odział Kliniczny Onkologii
Kraków , 31-50, Poland
Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie, Klinika Gastroenterologii Onkologicznej
Warszawa , 02-78, Poland
Saint Constantin Hospital (TEO HEALTH SA)
Brasov , 50009, Romania
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca, Sectia de Radioterapie I
Cluj-Napoca , 40001, Romania
S.C. Medisprof S.R.L.
Cluj-Napoca , 40005, Romania
Centrul de Oncologie "Sf. Nectarie", Sectia de Oncologie Medicala
Craiova , 20034, Romania
State Budgetary Healthcare Institution of Arkhangelsk Region "Arkhangelsk Clinical Oncology Dispensary"
Arkhangelsk , 16304, Russian Federation
State Healthcare Institution "Kursk Regional Clinical Oncology Dispensary"
Kursk , 30503, Russian Federation
Omsk regional clinical oncology center
Omsk , 64401, Russian Federation
Budgetary Healthcare Institution of Orel Region "Orel Oncology Dispensary"
Oryol , 30202, Russian Federation
State Budgetary Healthcare Institution of Stavropol Territory "Pyatigorsk Oncology Dispensary"
Pyatigorsk , 35750, Russian Federation
Ogarev Mordovia State University
Saransk , 43003, Russian Federation
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
St. Petersburg , 19702, Russian Federation
State Budgetary Healthcare Institution "Republican Clinical Oncology Dispensary"
Ufa , 45005, Russian Federation
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 Niaosong Dist, 83301, Taiwan
Kaohsiung Medical University Hospital
Kaohsiung 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 6, United Kingdom
The Christie NHS Foundation Trust
Manchester , M20 4, United Kingdom
Royal Marsden Hospital Surrey
Sutton , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 3

Estimated Enrollment:

460

Study ID:

NCT03042611

Recruitment Status:

Completed

Sponsor:


Elevar Therapeutics

How clear is this clinincal trial information?

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