Study of Ramucirumab (IMC-1121B) Therapy and Corrected QT (QTc) Interval Changes

• Number of Participants with Adverse Events (AEs) [ Time Frame: Approximately 10 weeks ] [ Designated as safety issue: Yes ]
• Maximum concentration (Cmax) [ Time Frame: Approximately week 1 (Cycle 1, Day 1) ] [ Designated as safety issue: No ]
• Maximum concentration (Cmax) [ Time Frame: Approximately week 1 (Cycle 1, Day 4) ] [ Designated as safety issue: No ]
• Maximum concentration (Cmax) [ Time Frame: Approximately week 2 (Cycle 1, Day 8) ] [ Designated as safety issue: No ]
• Maximum concentration (Cmax) [ Time Frame: Approximately week 3 (Cycle 1, Day 15) ] [ Designated as safety issue: No ]
• Maximum concentration (Cmax) [ Time Frame: Approximately week 1 (Cycle 2, Day 1) ] [ Designated as safety issue: No ]
• Maximum concentration (Cmax) [ Time Frame: Approximately week 1 (Cycle 3, Day 1) ] [ Designated as safety issue: No ]
• Area under concentration (AUC) [ Time Frame: Approximately week 1 (Cycle 1, Day 1) ] [ Designated as safety issue: No ]
• Area under concentration (AUC) [ Time Frame: Approximately week 1 (Cycle 1, Day 4) ] [ Designated as safety issue: No ]
• Area under concentration (AUC) [ Time Frame: Approximately week 2 (Cycle 1, Day 8) ] [ Designated as safety issue: No ]
• Area under concentration (AUC) [ Time Frame: Approximately week 3 (Cycle 1, Day 15) ] [ Designated as safety issue: No ]
• Area under concentration (AUC) [ Time Frame: Approximately week 1 (Cycle 2, Day 1) ] [ Designated as safety issue: No ]
• Area under concentration (AUC) [ Time Frame: Approximately week 1 (Cycle 3, Day 1) ] [ Designated as safety issue: No ]

• Safety profile of Ramucirumab [ Time Frame: 9 - 10 weeks ] [ Designated as safety issue: Yes ]
• pharmacokinetic characteristics of ramucirumab [ Time Frame: 9 - 10 weeks ] [ Designated as safety issue: No ]

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

The primary purpose of this study is to determine if treatment with ramucirumab causes prolongation of the QTc/QT interval in patient with advanced cancer, to assess the safety and tolerability of ramucirumab therapy, and to evaluate the PK characteristics of ramucirumab

• Cancer
• Solid Tumor

Inclusion Criteria:

• The patient 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 patient has resolution of adverse events from prior anticancer therapies
• Performance status of 0 to 2
• The patient is ≥ 18 years of age
• The patient is able to provide informed written consent and is amenable to compliance with protocol schedules and testing
• The patient has adequate liver, kidney, blood, and blood clotting functions as defined in trial entrance criteria
• The patient agrees to use adequate contraception during the study period and for 8 weeks after the last dose of study treatment

Exclusion Criteria:

• The patient had anticancer therapy within 14 days (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
• The patient had therapeutic radiotherapy within 14 days prior to entering the study
• The patient has ongoing side effects ≥ Grade 2 due to prior anticancer therapy
• The patient has brain or leptomeningeal metastases
• The patient has a history of uncontrolled or severe cardiac disease
• The patient has a history of severe congestive heart failure (CHF)
• The patient has a known history of arterial thrombotic events
• The patient has a known history of significant peripheral arterial disease (PAD)
• The patient has an implantable pacemaker or automatic implantable cardioverter defibrillator (AICD)
• The patient has a history of risk factors for ventricular tachycardia or Torsades de pointes (TdP) [eg, family history (parents or siblings) of long QT syndrome], history of fainting, unexplained loss of consciousness, or convulsions
• The patient has a blood pressure (SBP) of > 150 mmHg or < 90 mmHg or a diastolic blood pressure (DBP) of < 45 or > 95 mmHg. (Patients with a history of hypertension who are receiving antihypertensive therapy are permitted on study provided blood pressure is within the parameters detailed above)
• The patient has a heart rate < 50 bpm or > 100 bpm at rest
• The patient has a clinically relevant abnormality on the ECG, preventing an accurate measurement of the QT interval
• The patient is using a medication that is known to prolong the ECG QT interval
• The patient has a known allergy to any of the treatment components including fluoroquinolone antibiotics
• The patient 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 patient has undergone major surgery within 28 days prior to enrollment
• The patient has known human immunodeficiency virus (HIV) infection
• The patient, if female, is pregnant or lactating
• The patient is receiving chronic daily treatment with aspirin (> 325 mg/day)
• The patient has a concurrent active malignancy other than adequately treated nonmelanomatous skin cancer, other noninvasive carcinoma, or in situ neoplasm
• The patient has psychological, familial, sociological, or geographical conditions which do not permit adequate study follow-up, compliance with the protocol, or signature of Informed Consent