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

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Diphenhydramine; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Promethazine; Ramucirumab

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