A Study of Ramucirumab (LY3009806) Given by Injection Under the Skin in Participants With Advanced Cancer
Condition: Advanced Solid Tumor
Intervention: Ramucirumab
Intervention description: Administered SC
Intervention MeSH terms: Ramucirumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Safety

Summary:

      The purpose of this study in participants with advanced cancer is to learn more about the
      safety of ramucirumab when given by injection under the skin (subcutaneous injection). The
      study will also measure how much ramucirumab gets into the bloodstream and how long it takes
      the body to get rid of it.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have evaluable disease per Response Evaluation Criteria in Solid Tumors version 1.1
             (RECIST 1.1).

          -  In the judgment of the investigator, be an appropriate candidate for experimental
             therapy and:

               -  For Cohort A only: Have exhausted all anticancer treatments with proven clinical
                  benefit OR

               -  For Cohorts B and C only: Must have one of the three conditions below:

                    -  Have exhausted all anti-cancer treatments with proven clinical benefit, OR

                    -  Have hepatocellular carcinoma or gastric cancer who have received prior
                       treatment, and where IV ramucirumab monotherapy is clinically acceptable
                       treatment after progression OR

                    -  Have a diagnosis for which IV ramucirumab in combination with additional
                       anticancer therapy is clinically acceptable treatment

                    -  Additionally, it must be clinically acceptable to delay initiation of the
                       combination partner for 3 weeks from the initiation of ramucirumab dosing.

          -  Eastern Cooperative Oncology Group performance status score of 0 or 1.

          -  Have discontinued all previous treatments for cancer with adequate wash-out period and
             recovered from the acute effects of therapy.

          -  Have adequate hematologic, hepatic, and renal functions and electrolytes.

          -  Males and females of child-bearing potential must agree to use highly effective
             contraceptive methods during study treatment and for at least 84 days/12 weeks
             following the last dose of study drug.

        Exclusion Criteria:

          -  Have uncontrolled hypertension defined as systolic blood pressure (BP) >150 mmHg or
             diastolic BP >90 mmHg despite standard medical management.

          -  Have significant bleeding disorders or experienced Grade 3/4 gastrointestinal (GI)
             bleeding within 3 months prior to enrollment.

          -  Have hepatic impairment (such as severe liver cirrhosis Child-Pugh B [or worse],
             cirrhosis with a history of hepatic encephalopathy, clinically meaningful ascites
             requiring ongoing treatment with diuretics and/or paracentesis, or history of
             hepatorenal syndrome).

          -  Have experienced any arterial thromboembolic events (ATEs), including but not limited
             to myocardial infarction, transient ischemic attack, cerebrovascular accident, or
             unstable angina, ≤6 months prior to randomization.

          -  The participant has clinically relevant congestive heart failure (CHF; New York Heart
             Association [NYHA] Grade ≥2) or symptomatic or poorly controlled cardiac arrhythmia.

          -  Have symptomatic central nervous system (CNS) metastases. Screening is not required.

          -  Have history of GI perforation and/or fistula within 6 months prior to enrollment.

          -  Have an active uncontrolled systemic bacterial, viral, or fungal infection or serious
             ongoing uncontrolled intercurrent illness.

          -  Have a serious or non-healing wound, ulcer, or bone fracture within 4 weeks prior to
             enrollment.

          -  Have received IV ramucirumab in the past.