Study of Ramucirumab (IMC-1121B) Therapy and Corrected QT (QTc) Interval Changes
Condition: Cancer; Solid Tumor
Intervention: IMC-1121B; Moxifloxacin; Diphenhydramine
Intervention description: IMC-1121B (Ramucirumab) 10 mg/kg intravenously (IV) over 60 minutes, once every 3 weeks for minimum of 9 weeks.; Administered orally; Administered IV
Intervention MeSH terms: Diphenhydramine; Promethazine; Moxifloxacin; Ramucirumab
Phase: Phase 2
Study type: Interventional
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced Solid tumor; Antibodies, Monoclonal; QTc; Metastatic; Malignant

Summary:

      The purpose of this study is to determine if Ramucirumab (IMC-1121B) causes prolongation of
      the QT/QTc interval in participants with advanced cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The participant has histologically documented advanced or metastatic malignant cancer
             of solid tumor origin which has not responded to standard therapy or for which no
             standard therapy is available

          -  The participant has resolution of adverse events from prior anticancer therapies

          -  Performance status of 0 to 2

          -  The participant is ≥ 18 years of age

          -  The participant is able to provide informed written consent and is amenable to
             compliance with protocol schedules and testing

          -  The participant has adequate liver, kidney, blood, and blood clotting functions as
             defined in trial entrance criteria

          -  The participant agrees to use adequate contraception during the study period and for 8
             weeks after the last dose of study treatment

        Exclusion Criteria:

          -  The participant had anticancer therapy within 14 days (6 weeks for nitrosoureas or
             mitomycin C) prior to entering the study

          -  The participant had therapeutic radiotherapy within 14 days prior to entering the
             study

          -  The participant has ongoing side effects ≥ Grade 2 due to prior anticancer therapy

          -  The participant has brain or leptomeningeal metastases

          -  The participant has a history of uncontrolled or severe cardiac disease

          -  The participant has a history of severe congestive heart failure (CHF)

          -  The participant has a known history of arterial thrombotic events

          -  The participant has a known history of significant peripheral arterial disease (PAD)

          -  The participant has an implantable pacemaker or automatic implantable cardioverter
             defibrillator (AICD)

          -  The participant has a history of risk factors for ventricular tachycardia or Torsades
             de pointes (TdP) [for example, family history (parents or siblings) of long QT
             syndrome], history of fainting, unexplained loss of consciousness, or convulsions

          -  The participant has a systolic blood pressure (SBP) of > 150 millimeters of mercury
             (mmHg) or < 90 mmHg or a diastolic blood pressure (DBP) of < 45 or > 95 mmHg.
             (Participants with a history of hypertension who are receiving antihypertensive
             therapy are permitted on study provided blood pressure is within the parameters
             detailed above)

          -  The participant has a heart rate < 50 beats per minute (bpm) or > 100 bpm at rest

          -  The participant has a clinically relevant abnormality on the ECG, preventing an
             accurate measurement of the QT interval

          -  The participant is using a medication that is known to prolong the ECG QT interval

          -  The participant has a known allergy to any of the treatment components including
             fluoroquinolone antibiotics

          -  The participant has received an investigational new drug or device within 14 days
             prior to enrollment into this study (excluding placement of an intravenous access
             device)

          -  The participant has undergone major surgery within 28 days prior to enrollment

          -  The participant has known human immunodeficiency virus (HIV) infection

          -  The participant, if female, is pregnant or lactating

          -  The participant is receiving chronic daily treatment with aspirin [> 325 milligrams
             per day (mg/day)]

          -  The participant has a concurrent active malignancy other than adequately treated
             nonmelanomatous skin cancer, other noninvasive carcinoma, or in situ neoplasm

          -  The participant has psychological, familial, sociological, or geographical conditions
             which do not permit adequate study follow-up, compliance with the protocol, or
             signature of Informed Consent