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
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).
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,
trastuzumab in case of human epidermal growth factor receptor 2 (HER2)-positive,
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.
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.
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There are 94 Locations for this study
Scottsdale Arizona, 85259, United States
Rogers Arkansas, 72758, United States
Detroit Michigan, 48201, United States
Rochester Minnesota, 55905, United States
Hawthorne New York, 10532, United States
Levallois-Perret , 92300, France
Lyon , 69008, France
Montpellier , 34298, France
Nice , 06189, France
Villejuif , 94805, France
Berlin , 13353, Germany
Frankfurt , 60488, Germany
Hamburg , 20249, Germany
Marburg , 35043, Germany
Catanzaro , 88100, Italy
Faenza , 48018, Italy
Milano , 20133, Italy
Modena , 41124, Italy
Padova , 35128, Italy
Piacenza , 29121, Italy
Pontedera , 56025, Italy
Reggio Emilia , 42123, Italy
Rimini , 47923, Italy
Torrette , 60126, Italy
Hyogo Akasi-city, 673-0, Japan
Chiba Chiba City, 260-8, Japan
Tokyo Chuo-ku, 104-0, Japan
Fukuoka Higashi-ku, 812-8, Japan
Chiba Kashiwa, 277-8, Japan
Kanagawa Kawasaki-shi, 216-8, Japan
Saitama Kitaadachi-gun, 362-0, Japan
Fukuoka Kitakyushu-shi, 806-8, Japan
Tokyo Koto-ku, 135-8, Japan
Ehime Matsuyama, 791-0, Japan
Nagano Saku-shi, 385-0, Japan
Hokkaido Sapporo, 060-8, Japan
Tokyo Shinjuku-ku, 160-8, Japan
Osaka Suita, 565-0, Japan
Nagoya , 464-8, Japan
Anyang-si Gyeonggi-do, 14069, Korea, Republic of
Goyang-si Gyeonggi-do, 10408, Korea, Republic of
Suwon-si Gyonggi-do, 16499, Korea, Republic of
Busan , 48108, Korea, Republic of
Busan , 49201, Korea, Republic of
Busan , 49241, Korea, Republic of
Chuncheon , 41404, Korea, Republic of
Chungbuk , 54907, Korea, Republic of
Daegu , 41404, Korea, Republic of
Daegu , 41931, Korea, Republic of
Daegu , 42415, Korea, Republic of
Daejeon , 35015, Korea, Republic of
Gyeonggi-do , 13620, Korea, Republic of
Incheon , 21555, Korea, Republic of
Seoul , 02841, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05368, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06273, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 08308, Korea, Republic of
Ulsan , 44033, Korea, Republic of
Kraków , 31-50, Poland
Warszawa , 02-78, Poland
Brasov , 50009, Romania
Cluj-Napoca , 40001, Romania
Cluj-Napoca , 40005, Romania
Craiova , 20034, Romania
Arkhangelsk , 16304, Russian Federation
Kursk , 30503, Russian Federation
Omsk , 64401, Russian Federation
Oryol , 30202, Russian Federation
Pyatigorsk , 35750, Russian Federation
Saransk , 43003, Russian Federation
St. Petersburg , 19702, Russian Federation
Ufa , 45005, Russian Federation
Taipei Beitou Dist, 11217, Taiwan
Taoyuan Kuei Shan Hsiang, 333, Taiwan
Tainan Liuying DIst, 736, Taiwan
Kaohsiung Niaosong Dist, 83301, Taiwan
Kaohsiung Sanmin Dist, 80708, Taiwan
Taichung Taichung City, 40447, Taiwan
Tainan Tainan City, 70403, Taiwan
Taipei Zhongzheng Dist, 100, Taiwan
Dnipro , 49102, Ukraine
Ivano-Frankivsk , 76000, Ukraine
Kharkiv , 61070, Ukraine
Kherson , 73035, Ukraine
Kryvyi Rih , 50048, Ukraine
Kyiv , 03115, Ukraine
Uzhhorod , 88014, Ukraine
Vinnytsia , 21029, Ukraine
Zaporizhzhia , 69040, Ukraine
London , SW3 6, United Kingdom
Manchester , M20 4, United Kingdom
Sutton , SM2 5, United Kingdom
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