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

NCT03042611 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: LSK-AM301
• Study Type: interventional
• Target: 460
• Locations: 12 countries
• Sites: 95

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

Keywords

Gastric Cancer; Gastric Adenocarcinoma; Gastro-esophageal Cancer; Gastro-esophageal Junction Cancer; Stomach Cancer; Tumor; Oncology; Antiangiogenesis; Metastatic

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1 (randomization) up to approximately 36 months

Secondary Outcomes (7)

• Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

  Up to approximately 24 months

• Objective Response Rate (ORR) Per RECIST 1.1

  Up to approximately 24 months

• Disease Control Rate (DCR)

  Up to approximately 24 months

• 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)

  Baseline, End of Treatment (EOT) (Up to 24 months)

• Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22) Score

  Baseline, EOT (Up to 24 months)

Study Arms (2)

Rivoceranib Plus BSC

EXPERIMENTAL

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.

Drug: Rivoceranib

Placebo

EXPERIMENTAL

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.

Drug: Placebo

Interventions

Rivoceranib DRUG

Oral tablet

Also known as: Apatinib

Rivoceranib Plus BSC

Placebo DRUG

Oral tablet

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Elevar Therapeutics: lead

Study Sites (95)

Mayo Clinic Phoenix

Scottsdale, Arizona, 85259, United States

Location

Highlands Oncology Group

Rogers, Arkansas, 72758, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Hudson Valley Cancer Centre

Hawthorne, New York, 10532, United States

Location

Centre Hospitalier Franco-Britannique; Oncologie Médicale

Levallois-Perret, 92300, France

Location

Centre Leon-Berard (CLB)

Lyon, 69008, France

Location

Institut Regional du Cancer Montpellier (ICM)

Montpellier, 34298, France

Location

Centre Antoine-Lacassagne

Nice, 06189, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

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

Berlin, 13353, Germany

Location

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

Frankfurt, 60488, Germany

Location

Facharztzentrum Eppendorf - Haematologisch-Onkologische Praxis Eppendorf (HOPE)

Hamburg, 20249, Germany

Location

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

Marburg, 35043, Germany

Location

Magna Graecia University- Department of Experimental and Clinical Medicine

Catanzaro, 88100, Italy

Location

U.O Di Oncologia Ospedale Degli Infermi

Faenza, 48018, Italy

Location

Fondazione IRCCS-Istituto Nazionale Tumori

Milan, 20133, Italy

Location

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

Modena, 41124, Italy

Location

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

Padua, 35128, Italy

Location

Ospedale di Piacenza - Oncology and heamatology

Piacenza, 29121, Italy

Location

Ospedale "Felice Lotti"

Pontedera, 56025, Italy

Location

IRCCS/Arcispedale Santa Maria Nuova

Reggio Emilia, 42123, Italy

Location

Rimini Hospital

Rimini, 47923, Italy

Location

Ospedali Riuniti di Ancona - SOD Clinica Oncologica

Torrette, 60126, Italy

Location

Hyogo Cancer Center

Hyōgo, Akasi-city, 673-0021, Japan

Location

Chiba Cancer Center

Chiba, Chiba City, 260-8717, Japan

Location

National Cancer Center Hospital

Tokyo, Chuo-ku, 104-0045, Japan

Location

Kyushu University Hospital

Fukuoka, Higashi-ku, 812-8582, Japan

Location

National Cancer Center Hospital East

Chiba, Kashiwa, 277-8577, Japan

Location

St. Marianna University School of Medicine Hospital

Kanagawa, Kawasaki-shi, 216-8511, Japan

Location

Saitama Cancer Center

Saitama, Kitaadachi-gun, 362-0806, Japan

Location

Japan Community Health Care Organization Kyushu Hospital

Fukuoka, Kitakyushu-shi, 806-8501, Japan

Location

The Cancer Institute Hospital of Japanese Foundation For Cancer Research

Tokyo, Koto-ku, 135-8550, Japan

Location

National Hospital Organization Shikoku Cancer Center

Ehime, Matsuyama, 791-0280, Japan

Location

Saku Central Hospital Advanced Care Center

Nagano, Saku-shi, 385-0051, Japan

Location

Hokkaido University Hospital

Hokkaido, Sapporo, 060-8648, Japan

Location

Keio University Hospital

Tokyo, Shinjuku-ku, 160-8582, Japan

Location

Osaka University Hospital

Osaka, Suita, 565-0871, Japan

Location

Aichi Cancer Center Hospital

Nagoya, 464-8681, Japan

Location

Szpital Uniwersytecki w Krakowie, Odział Kliniczny Onkologii

Krakow, 31-501, Poland

Location

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

Warsaw, 02-781, Poland

Location

Saint Constantin Hospital (TEO HEALTH SA)

Brasov, 500091, Romania

Location

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

Cluj-Napoca, 400015, Romania

Location

S.C. Medisprof S.R.L.

Cluj-Napoca, 400058, Romania

Location

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

Craiova, 200347, Romania

Location

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

Arkhangelsk, 163045, Russia

Location

State Healthcare Institution "Kursk Regional Clinical Oncology Dispensary"

Kursk, 305035, Russia

Location

Omsk regional clinical oncology center

Omsk, 644013, Russia

Location

Budgetary Healthcare Institution of Orel Region "Orel Oncology Dispensary"

Oryol, 302020, Russia

Location

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

Pyatigorsk, 357502, Russia

Location

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, 197022, Russia

Location

Ogarev Mordovia State University

Saransk, 430032, Russia

Location

State Budgetary Healthcare Institution "Republican Clinical Oncology Dispensary"

Ufa, 450054, Russia

Location

Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggi-do, 14069, South Korea

Location

National Cancer Center

Goyang-si, Gyeonggi-do, 10408, South Korea

Location

Ajou University Hospital

Suwon, Gyonggi-do, 16499, South Korea

Location

Inje University Haeundae Paik Hospital

Busan, 48108, South Korea

Location

Dong-A University Hospital

Busan, 49201, South Korea

Location

Pusan National University Hospital

Busan, 49241, South Korea

Location

Chungbuk National University Medical Center

Chuncheon, 41404, South Korea

Location

Kyungpook National University Medical Center

Daegu, 41404, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, 41931, South Korea

Location

Yeungnam University Medical Center

Daegu, 42415, South Korea

Location

Chungnam National University Hospital

Daejeon, 35015, South Korea

Location

Seoul National University Bundang Hospital

Gyeonggi-do, 13620, South Korea

Location

Gachon University Gil Medical Center

Incheon, 21555, South Korea

Location

Chungbuk National University Hospital

Jungbuk, 54907, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Severence Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Veterans Health Service (VHS) Medical Center

Seoul, 05368, South Korea

Location

ASAN Medical Center

Seoul, 05505, South Korea

Location

Gangnam Severance Hospital

Seoul, 06273, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Ulsan University Hospital

Ulsan, 44033, South Korea

Location

Taipei Veterans General Hospital

Taipei, Beitou Dist, 11217, Taiwan

Location

Chang Gung Memorial Hospital - Linko Branch

Taoyuan District, Kuei Shan Hsiang, 333, Taiwan

Location

Chi Mei Medical Center - LiouYing Branch

Tainan, Liuying DIst, 736, Taiwan

Location

Chang Gung Memorial Hospital - Kaohsiung Branch

Kaohsiung City, Niaosong Dist, 83301, Taiwan

Location

Kaohsiung Medical University Hospital

Kaohsiung City, Sanmin Dist, 80708, Taiwan

Location

China Medical University Hospital

Taichung, Taichung City, 40447, Taiwan

Location

National CHeng Kung University Hospital

Tainan, Tainan City, 70403, Taiwan

Location

National Taiwan University Hospital

Taipei, Zhongzheng Dist, 100, Taiwan

Location

Dnipropetrovsk Medical Academy, Department of Oncology

Dnipro, 49102, Ukraine

Location

Communal Institution "Ivano-Frankivsk Regional Oncological Center"

Ivano-Frankivsk, 76000, Ukraine

Location

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

Kharkiv, 61070, Ukraine

Location

Kherson Regional Oncological Dispensary

Kherson, 73035, Ukraine

Location

Municipal Institution Kryvyi Rig Oncology Dispensary", Chemotherapy Department

Kryvyi Rih, 50048, Ukraine

Location

Municipal Institution "Kyiv City Clinical Oncological Center"

Kyiv, 03115, Ukraine

Location

Communal Institution "Transcarpathian Regional Clinical Oncological Center"

Uzhhorod, 88014, Ukraine

Location

Communal Institution "Vinnytsia Regional Clinical Oncology Dispensary"

Vinnytsia, 21029, Ukraine

Location

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

Location

Royal Marsden Hospital London

London, SW3 6JJ, United Kingdom

Location

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

Royal Marsden Hospital Surrey

Sutton, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Stomach Neoplasms; Neoplasms; Neoplasm Metastasis

Interventions

apatinib

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Elevar Clinical Trials
• Organization: Elevar Therapeutics, Inc

info-clinicalstudy@elevartherapeutics.com

(801) 303-7440

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2017
• First Posted: February 3, 2017
• Study Start: March 14, 2017
• Primary Completion: February 15, 2019
• Study Completion: September 23, 2020
• Last Updated: July 8, 2022
• Results First Posted: July 8, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3); US (5); RU (8); JP (15); IT (10); DE (4); RO (4); PL (2); TW (8); KR (22); UA (9); FR (5)