Clinical Trials /

A Study of Ramucirumab (LY3009806) in Combination With Capecitabine and Cisplatin in Participants With Stomach Cancer

NCT02314117

Description:

The main purpose of this study is to evaluate the efficacy of ramucirumab, which is a targeted antibody, in combination with capecitabine and cisplatin compared to capecitabine and cisplatin alone in participants with stomach cancer.

Related Conditions:
  • Adenocarcinoma of the Gastroesophageal Junction
  • Gastric Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

A Study of <span class="go-doc-concept go-doc-intervention">Ramucirumab</span> (<span class="go-doc-concept go-doc-intervention">LY3009806</span>) in Combination With <span class="go-doc-concept go-doc-intervention">Capecitabine</span> and <span class="go-doc-concept go-doc-intervention">Cisplatin</span> in Participants With Stomach <span class="go-doc-concept go-doc-disease">Cancer</span>

Title

  • Brief Title: A Study of Ramucirumab (LY3009806) in Combination With Capecitabine and Cisplatin in Participants With Stomach Cancer
  • Official Title: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Capecitabine and Cisplatin With or Without Ramucirumab as First-line Therapy in Patients With Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (RAINFALL)
  • Clinical Trial IDs

    NCT ID: NCT02314117

    ORG ID: 15372

    NCI ID: I4T-MC-JVCU

    Trial Conditions

    Metastatic Gastric Adenocarcinoma

    Gastroesophageal Junction Adenocarcinoma

    Trial Interventions

    Drug Synonyms Arms
    Ramucirumab LY3009806, IMC-1121B, Cyramza Ramucirumab + Cisplatin + Capecitabine
    Capecitabine Ramucirumab + Cisplatin + Capecitabine, Placebo + Cisplatin + Capecitabine
    Cisplatin Ramucirumab + Cisplatin + Capecitabine, Placebo + Cisplatin + Capecitabine
    Placebo Placebo + Cisplatin + Capecitabine
    Fluorouracil Ramucirumab + Cisplatin + Capecitabine, Placebo + Cisplatin + Capecitabine

    Trial Purpose

    The main purpose of this study is to evaluate the effectiveness of ramucirumab, which is a
    targeted antibody, in combination with capecitabine and cisplatin compared to capecitabine
    and cisplatin alone in participants with stomach cancer.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Ramucirumab + Cisplatin + Capecitabine Experimental 8 milligrams/kilogram (mg/kg) ramucirumab given intravenously (IV) on days 1 and 8 in combination with 80 mg/square meter (m^2) cisplatin given IV on day 1 of each 21 day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that are unable to take capecitabine will be given 800 mg/m^2/day fluorouracil (5-FU) IV on days 1 to 5 of each 21 day cycle. Ramucirumab, Capecitabine, Cisplatin, Fluorouracil
    Placebo + Cisplatin + Capecitabine Active Comparator Placebo for blinding given IV on days 1 and 8 in combination with 80 mg/m^2 cisplatin given IV on day 1 of each 21 day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that are unable to take capecitabine will be given 800 mg/m^2/day 5-FU IV on days 1 to 5 of each 21 day cycle. Capecitabine, Cisplatin, Placebo, Fluorouracil

    Eligibility Criteria

    Inclusion Criteria:

    - Have a histopathologically confirmed diagnosis of metastatic gastric or
    gastroesophageal junction (GEJ) adenocarcinoma. All histologies of nonsquamous cell
    origin including undifferentiated gastric carcinoma are eligible.

    - Have not received any prior first-line systemic therapy (prior adjuvant or
    neo-adjuvant therapy is permitted). Participants whose disease has progressed after
    >12 months following the last dose of systemic treatment in the adjuvant/neoadjuvant
    setting are eligible.

    - Have measurable or nonmeasurable but evaluable disease determined using guidelines in
    Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v 1.1). Baseline
    tumor assessment should be performed using a high resolution computed tomography (CT)
    scan using IV and oral contrast unless clinically contra-indicated. Magnetic
    resonance imaging (MRI) is acceptable if a CT cannot be performed.

    - Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale
    at baseline.

    - Have adequate organ function.

    - Have baseline clinical and laboratory parameters that are consistent with the
    requirements prescribed in respective labels and are suitable for consideration of
    treatment with capecitabine (or 5-FU) and cisplatin (for example, dihydropyrimidine
    dehydrogenase deficiency).

    - Have an estimated life expectancy of 12 weeks in the judgment of the investigator.

    Exclusion Criteria:

    - Participants with adenocarcinoma of the esophagus are excluded.

    - Participants with human epidermal growth factor receptor 2 (HER2)-positive status.

    - Participants receiving chronic therapy with nonsteroidal anti-inflammatory agents.

    - Have radiation therapy within 14 days prior to randomization.

    - Have documented brain metastases, leptomeningeal disease or uncontrolled spinal cord
    compression.

    - Have significant bleeding disorders, vasculitis, or had a significant bleeding
    episode from the gastrointestinal tract within 12 weeks prior to randomization.

    - Have experienced any arterial thromboembolic event, including myocardial infarction,
    unstable angina, cerebrovascular accident, or transient ischemic attack, within 6
    months prior to randomization.

    - Have symptomatic congestive heart failure (New York Heart Association II-IV) or
    symptomatic or poorly controlled cardiac arrhythmia.

    - Have uncontrolled hypertension prior to initiating study treatment, despite
    antihypertensive intervention.

    - Have undergone major surgery within 28 days prior to randomization, or central venous
    access device placement within 7 days prior to first dose of study treatment, except
    if the procedure is minimally invasive (for example, introduction of peripherally
    inserted central catheter [PICC] line) and the investigator does not anticipate any
    significant bleeding.

    - Have a history of gastrointestinal perforation and/or fistulae within 6 months prior
    to randomization.

    - Have a history of inflammatory bowel disease or Crohn's disease requiring medical
    intervention (immunomodulatory or immunosuppressive medications or surgery) 12
    months prior to randomization.

    - Have an acute or subacute bowel obstruction or history of chronic diarrhea which is
    considered clinically significant in the opinion of the investigator.

    - The participant has:

    - cirrhosis at a level of Child-Pugh B (or worse) or

    - cirrhosis (any degree) and a history of hepatic encephalopathy or clinically
    meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is
    defined as ascites resulting from cirrhosis and requiring ongoing treatment with
    diuretics and/or paracentesis.

    - Have known allergy or hypersensitivity to any components of study treatment.

    - Are pregnant or lactating.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Progression Free Survival (PFS)

    Secondary Outcome Measures

    Overall Survival (OS)

    Progression Free Survival 2 (PFS2)

    Objective Response Rate (ORR)

    Disease Control Rate (DCR)

    Time to Progression (TTP)

    Duration of Response (DoR)

    Change from Randomization to 30 Days After Treatment Discontinuation in Quality of Life on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

    Change from Randomization to 30 Days After Treatment Discontinuation in Health Status on the European Quality of Life 5-Dimensions 5 Level Instrument (EQ-5D- 5L)

    Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)

    Pharmacokinetics (PK): Minimum Ramucirumab Concentration (Cmin) and Concentration at 1-Hour Post End of Ramucirumab Infusion (Approximately Maximum Concentration [Cmax])

    Number of Participants with Anti-Ramucirumab Antibodies

    Trial Keywords