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

Completed · Phase 3 · Has a placebo group

Conditions studied: Gastric Cancer, Gastric Adenocarcinoma

In brief

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).

Key facts

Study ID

NCT03042611

Run by

Elevar Therapeutics

People needed

460

Starts

2017-03-14

Expected to finish

2020-09-23

Last updated by the study team

2022-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• Expected survival of ≥12 weeks, in the opinion of the investigator.

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.

Where it is running

• 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 — Padova, 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
• Mayo Clinic Phoenix — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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