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

NCT ID: NCT03042611

Last Updated: 2022-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 460 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-14
• Study Completion Date: 2020-09-23

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).

Conditions

Gastric Cancer; Gastric Adenocarcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Rivoceranib Plus BSC

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.

Group Type: EXPERIMENTAL

Rivoceranib

Intervention Type: DRUG

Oral tablet

Placebo

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.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Oral tablet

Interventions

Rivoceranib

Oral tablet

Intervention Type: DRUG

Placebo

Oral tablet

Intervention Type: DRUG

Other Intervention Names

Apatinib

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Elevar Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mayo Clinic Phoenix

Scottsdale, Arizona, United States

Highlands Oncology Group

Rogers, Arkansas, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Hudson Valley Cancer Centre

Hawthorne, New York, United States

Centre Hospitalier Franco-Britannique; Oncologie Médicale

Levallois-Perret, , France

Centre Leon-Berard (CLB)

Lyon, , France

Institut Regional du Cancer Montpellier (ICM)

Montpellier, , France

Centre Antoine-Lacassagne

Nice, , France

Institut Gustave Roussy

Villejuif, , France

Charite - Universitaetsmedizin Berlin - Medizinische Klinik mit Schwerpunkt Haematologie, Onkologie und Tumorimmunologie

Berlin, , Germany

"Institut für Klinisch-Onkologische Forschung (IKF) Krankenhaus Nordwest gGmbH UCT - Universitäres Centrum für Tumorerkrankungen Frankfurt

Frankfurt, , Germany

Facharztzentrum Eppendorf - Haematologisch-Onkologische Praxis Eppendorf (HOPE)

Hamburg, , Germany

Universitätsklinik Marburg, Klinik fur Innere Medizin, Schwerpunkt Haematologie, Onkologie und Immunologie

Marburg, , Germany

Magna Graecia University- Department of Experimental and Clinical Medicine

Catanzaro, , Italy

U.O Di Oncologia Ospedale Degli Infermi

Faenza, , Italy

Fondazione IRCCS-Istituto Nazionale Tumori

Milan, , Italy

Policlinico di Modena-Azienda Ospedaliero Universitaria di Modena.Oncologia ed Ematologia.

Modena, , Italy

Veneto Oncology Institute (IOV-IRCCS), Melanoma & Esophageal Oncology Unit

Padua, , Italy

Ospedale di Piacenza - Oncology and heamatology

Piacenza, , Italy

Ospedale "Felice Lotti"

Pontedera, , Italy

IRCCS/Arcispedale Santa Maria Nuova

Reggio Emilia, , Italy

Rimini Hospital

Rimini, , Italy

Ospedali Riuniti di Ancona - SOD Clinica Oncologica

Torrette, , Italy

Hyogo Cancer Center

Hyōgo, Akasi-city, Japan

Chiba Cancer Center

Chiba, Chiba City, Japan

National Cancer Center Hospital

Tokyo, Chuo-ku, Japan

Kyushu University Hospital

Fukuoka, Higashi-ku, Japan

National Cancer Center Hospital East

Chiba, Kashiwa, Japan

St. Marianna University School of Medicine Hospital

Kanagawa, Kawasaki-shi, Japan

Saitama Cancer Center

Saitama, Kitaadachi-gun, Japan

Japan Community Health Care Organization Kyushu Hospital

Fukuoka, Kitakyushu-shi, Japan

The Cancer Institute Hospital of Japanese Foundation For Cancer Research

Tokyo, Koto-ku, Japan

National Hospital Organization Shikoku Cancer Center

Ehime, Matsuyama, Japan

Saku Central Hospital Advanced Care Center

Nagano, Saku-shi, Japan

Hokkaido University Hospital

Hokkaido, Sapporo, Japan

Keio University Hospital

Tokyo, Shinjuku-ku, Japan

Osaka University Hospital

Osaka, Suita, Japan

Aichi Cancer Center Hospital

Nagoya, , Japan

Szpital Uniwersytecki w Krakowie, Odział Kliniczny Onkologii

Krakow, , Poland

Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie, Klinika Gastroenterologii Onkologicznej

Warsaw, , Poland

Saint Constantin Hospital (TEO HEALTH SA)

Brasov, , Romania

Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca, Sectia de Radioterapie I

Cluj-Napoca, , Romania

S.C. Medisprof S.R.L.

Cluj-Napoca, , Romania

Centrul de Oncologie "Sf. Nectarie", Sectia de Oncologie Medicala

Craiova, , Romania

State Budgetary Healthcare Institution of Arkhangelsk Region "Arkhangelsk Clinical Oncology Dispensary"

Arkhangelsk, , Russia

State Healthcare Institution "Kursk Regional Clinical Oncology Dispensary"

Kursk, , Russia

Omsk regional clinical oncology center

Omsk, , Russia

Budgetary Healthcare Institution of Orel Region "Orel Oncology Dispensary"

Oryol, , Russia

State Budgetary Healthcare Institution of Stavropol Territory "Pyatigorsk Oncology Dispensary"

Pyatigorsk, , 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, , Russia

Ogarev Mordovia State University

Saransk, , Russia

State Budgetary Healthcare Institution "Republican Clinical Oncology Dispensary"

Ufa, , Russia

Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggi-do, South Korea

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Ajou University Hospital

Suwon, Gyonggi-do, South Korea

Inje University Haeundae Paik Hospital

Busan, , South Korea

Dong-A University Hospital

Busan, , South Korea

Pusan National University Hospital

Busan, , South Korea

Chungbuk National University Medical Center

Chuncheon, , South Korea

Kyungpook National University Medical Center

Daegu, , South Korea

Keimyung University Dongsan Medical Center

Daegu, , South Korea

Yeungnam University Medical Center

Daegu, , South Korea

Chungnam National University Hospital

Daejeon, , South Korea

Seoul National University Bundang Hospital

Gyeonggi-do, , South Korea

Gachon University Gil Medical Center

Incheon, , South Korea

Chungbuk National University Hospital

Jungbuk, , South Korea

Korea University Anam Hospital

Seoul, , South Korea

Severence Hospital, Yonsei University Health System

Seoul, , South Korea

Veterans Health Service (VHS) Medical Center

Seoul, , South Korea

ASAN Medical Center

Seoul, , South Korea

Gangnam Severance Hospital

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Korea University Guro Hospital

Seoul, , South Korea

Ulsan University Hospital

Ulsan, , South Korea

Taipei Veterans General Hospital

Taipei, Beitou Dist, Taiwan

Chang Gung Memorial Hospital - Linko Branch

Taoyuan District, Kuei Shan Hsiang, Taiwan

Chi Mei Medical Center - LiouYing Branch

Tainan City, Liuying DIst, Taiwan

Chang Gung Memorial Hospital - Kaohsiung Branch

Kaohsiung City, Niaosong Dist, Taiwan

Kaohsiung Medical University Hospital

Kaohsiung City, Sanmin Dist, Taiwan

China Medical University Hospital

Taichung, Taichung City, Taiwan

National CHeng Kung University Hospital

Tainan City, Tainan City, Taiwan

National Taiwan University Hospital

Taipei, Zhongzheng Dist, Taiwan

Dnipropetrovsk Medical Academy, Department of Oncology

Dnipro, , Ukraine

Communal Institution "Ivano-Frankivsk Regional Oncological Center"

Ivano-Frankivsk, , Ukraine

Communal Institution "Kharkiv Regional Clinical Oncology Center ", Chemotherapy department #1, Medical Academy of Postgraduate Education, Oncology and Pediatric Oncology

Kharkiv, , Ukraine

Kherson Regional Oncological Dispensary

Kherson, , Ukraine

Municipal Institution Kryvyi Rig Oncology Dispensary", Chemotherapy Department

Kryvyi Rih, , Ukraine

Municipal Institution "Kyiv City Clinical Oncological Center"

Kyiv, , Ukraine

Communal Institution "Transcarpathian Regional Clinical Oncological Center"

Uzhhorod, , Ukraine

Communal Institution "Vinnytsia Regional Clinical Oncology Dispensary"

Vinnytsia, , 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, , Ukraine

Royal Marsden Hospital London

London, , United Kingdom

The Christie NHS Foundation Trust

Manchester, , United Kingdom

Royal Marsden Hospital Surrey

Sutton, , United Kingdom

Countries

United States; France; Germany; Italy; Japan; Poland; Romania; Russia; South Korea; Taiwan; Ukraine; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

LSK-AM301

Identifier Type: -

Identifier Source: org_study_id