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Phase 2 N=68

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

Cancer · Solid Tumor

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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