A Phase 2 Study of Ramucirumab (LY3009806) in Participants With Gastric or Gastroesophageal Junction (GEJ) Cancer
Condition: Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma
MeSH terms: Adenocarcinoma; Esophageal Neoplasms
Intervention: Ramucirumab
Intervention description: Administered IV
Intervention MeSH terms: Ramucirumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 164.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stomach cancer

Summary:

      The main purpose of this study was to evaluate the safety and pharmacokinetics of
      administering various dose regimens of ramucirumab in participants with advanced gastric
      cancer whose disease has progressed during or following prior chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The participant has a histopathologically or cytologically confirmed diagnosis of
             gastric or gastroesophageal junction (GEJ).

          -  The participant has documented disease progression during or within 4 months after the
             last dose of first-line chemotherapy for metastatic disease, or during or within 6
             months after the last dose of neoadjuvant or adjuvant therapy.

          -  The participant received combination chemotherapy prior to disease progression.

               -  Prior chemotherapy regimens must include a platinum and/or a fluoropyrimidine
                  component and must not include a taxane or antiangiogenic agent.

          -  The participant has metastatic disease or locally advanced disease that is measurable
             or nonmeasurable, but is evaluable disease by radiological imaging per Response
             Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).

          -  Patients are eligible if they are considered not appropriate, for whatever reason, for
             treatment with ramucirumab in combination with paclitaxel.

          -  The participant has an Eastern Cooperative Oncology Group (ECOG) performance status of
             0 or 1.

          -  The participant has adequate organ function, including:

               -  Total bilirubin 1.5 × the upper limit of institutional normal (ULN) and alanine
                  aminotransferase (ALT) and aspartate aminotransferase (AST) 3 × ULN. If the liver
                  has tumor involvement, AST and ALT <5 × ULN are acceptable.

               -  Serum creatinine 1.5 × ULN or calculated creatinine clearance (per the
                  Cockcroft-Gault formula or equivalent and/or 24-hour urine collection) 60
                  milliliters/minute (mL/min).

               -  Urinary protein is <2+ on dipstick or routine urinalysis.

               -  Absolute neutrophil count 1.5 × 10^9/Liter (L), platelets 100 × 10^9/L, and
                  hemoglobin 9 g/deciliter (dL) (5.58 millimoles/Liter).

               -  International normalized ratio 1.5 × ULN or prothrombin time 5 seconds above ULN.

               -  Partial thromboplastin time 5 seconds above ULN.

          -  The participant has an estimated life expectancy of 12 weeks in the judgment of the
             investigator.

          -  The participant, if female and of child-bearing potential, must have a negative serum
             or urine pregnancy test within 7 days prior to randomization.

        Exclusion Criteria:

          -  The participant has squamous cell or undifferentiated gastric cancer.

          -  The participant is receiving chronic therapy with any of the following within 7 days
             prior to randomization:

               -  Nonsteroidal anti-inflammatory agents (NSAIDs; such as indomethacin, ibuprofen,
                  naproxen, or similar agents), or

               -  Other anti-platelet agents (such as clopidogrel, ticlopidine, dipyridamole, or
                  anagrelide). Aspirin use at doses up to 325 milligrams (mg)/day is permitted.

          -  The participant received radiotherapy within 14 days prior to randomization.

          -  The participant received >1 line of prior therapy for the treatment of locally
             advanced and unresectable or metastatic gastric or GEJ (Siewert Types I-III)
             adenocarcinoma.

          -  The participant received previous treatment with agents targeting the vascular
             endothelial growth factor (VEGF)/VEGF receptor 2 signaling pathway.

          -  The participant has documented brain metastases, leptomeningeal disease, or
             uncontrolled spinal cord compression.

          -  The participant experienced any arterial thromboembolic event, including myocardial
             infarction, unstable angina, cerebrovascular accident, or transient ischemic attack,
             within 6 months prior to randomization.

          -  The participant has symptomatic congestive heart failure (New York Heart Association
             II-IV) or symptomatic or poorly controlled cardiac arrhythmia.

          -  The participant has uncontrolled hypertension, as defined in Common Terminology
             Criteria for Adverse Events (CTCAE) Version 4.0, prior to initiating study treatment,
             despite antihypertensive intervention.

          -  The participant underwent major surgery within 28 days prior to randomization or
             central venous access device placement within 7 days prior to randomization.

          -  The participant has a history of gastrointestinal perforation or fistula within 6
             months prior to randomization.

          -  The participant has any condition (for example, psychological, geographical, or
             medical) that does not permit compliance with the study and follow-up procedures or
             suggests that the participant is, in the investigator's opinion, not an appropriate
             candidate for the study.