Clinical trial · Interventional
Study of Ramucirumab (IMC-1121B) Therapy and Corrected QT (QTc) Interval Changes
A Study to Evaluate the Relationship Between Ramucirumab (IMC-1121B) Therapy and Corrected QT (QTc) Interval Changes in Patients With Advanced Cancer
NCT01017731CI-TRIAL-00018229completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine if Ramucirumab (IMC-1121B) causes prolongation of the QT/QTc interval in participants with advanced cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diphenhydramine | Drug | — | UNRESOLVED |
| IMC-1121B | Biological | Ramucirumab | ALIAS |
| Moxifloxacin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IMC-1121B
- description
- Active-control participants (first 16 participants) will receive one dose of moxifloxacin orally 7 days before the first treatment with ramucirumab. All participants will undergo triplicate electrocardiogram (ECG) tests (consisting of three individual ECGs performed consecutively within a period of 4 minutes) and vital signs at various times over the trial period. For Cycle 1, all participants will also receive 2 infusions of diphenhydramine before ramucirumab therapy (the first infusion is 1 day before therapy and the second infusion is 15 minutes before therapy). For Cycles 2, 3, and 4, all participants will receive diphenhydramine 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, diphenhydramine infusions before ramucirumab therapy are at the investigator's discretion. Ramucirumab \[10 milligrams per kilogram (mg/kg)\] intravenously over 60 minutes, once every 3 weeks for minimum of 9 weeks without a break in between.
- interventionNames
- Biological: IMC-1121B
- Drug: Moxifloxacin
- Drug: Diphenhydramine
Primary outcomes (1)
- measure
- Change From Baseline to Cycle 3 in QT/Corrected QT (QTc) Interval Prolongation in Participants
- timeFrame
- Baseline, Cycle 3 (1 cycle=21 days)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDOlszanski AJ, Smith DC, Camacho LH, Thompson J, Ramalingam SS, Harvey RD, Campos L, Ferry D, Tang S, Gao L, Safran H. Electrocardiographic Characterization of Ramucirumab on the Corrected QT Interval in a Phase II Study of Patients With Advanced Solid Tumors. Oncologist. 2016 Apr;21(4):402-3. doi: 10.1634/theoncologist.2015-0467. Epub 2016 Mar 16. PMID 26984445