Phase 2
N=68
Study of Ramucirumab (IMC-1121B) Therapy and Corrected QT (QTc) Interval Changes
Cancer · Solid Tumor
Bottom Line
View on ClinicalTrials.gov: NCT01017731 ↗Enrolled (actual)
68
Serious AEs
48.5%
Results posted
Jun 2014
Primary outcome: Primary: Change From Baseline to Cycle 3 in QT/Corrected QT (QTc) Interval Prolongation in Participants — 3.9132 milliseconds (msec) — p=0.0161
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- IMC-1121B (Biological); Moxifloxacin (Drug); Diphenhydramine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Cycle 3 in QT/Corrected QT (QTc) Interval Prolongation in Participants |
3.9132 | 0.0161 sig |
| SECONDARY Number of Participants With Drug-Related Adverse Events (AEs) |
42; 11; 14; 6 | — |
| SECONDARY Maximum Concentration (Cmax) During Cycle 1 |
485 | — |
| SECONDARY Maximum Concentration (Cmax) During Cycle 1, Day 4 |
— | — |
| SECONDARY Maximum Concentration (Cmax) During Cycle 1, Day 8 |
— | — |
| SECONDARY Maximum Concentration (Cmax) During Cycle 1, Day 15 |
— | — |
| SECONDARY Maximum Concentration (Cmax) During Cycle 2 |
— | — |
| SECONDARY Maximum Concentration (Cmax) During Cycle 3 |
571 | — |
| SECONDARY Area Under Concentration (AUC) During Cycle 1 |
67400 | — |
| SECONDARY Area Under Concentration (AUC) During Cycle 1, Day 4 |
— | — |
| SECONDARY Area Under Concentration (AUC) During Cycle 1, Day 8 |
— | — |
| SECONDARY Area Under Concentration (AUC) During Cycle 1, Day 15 |
— | — |
| SECONDARY Area Under Concentration (AUC) During Cycle 2, Day 1 |
— | — |
| SECONDARY Area Under Concentration (AUC) During Cycle 3 |
69900 | — |
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 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 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
Data sourced from ClinicalTrials.gov (NCT01017731). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.