A Study to Evaluate Rivoceranib Plus Best Supportive Care Compared to Placebo Plus Best Supportive Care in Participants With Gastric Cancer
Condition: Gastric Cancer; Gastric Adenocarcinoma
MeSH terms: Adenocarcinoma; Stomach Neoplasms
Intervention: Rivoceranib; Placebo
Intervention description: Oral tablet; Oral tablet
Intervention MeSH terms: Apatinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 460.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Gastric Cancer; Gastric Adenocarcinoma; Gastro-esophageal Cancer; Gastro-esophageal Junction Cancer; Stomach Cancer; Tumor; Oncology; Antiangiogenesis; Metastatic

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).
    

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.