A Study to Evaluate the Relationship Between Ramucirumab (IMC-1121B) Therapy and Corrected QT (QTc) Interval Changes in Patients With Advanced Cancer
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