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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Cancer, Solid Tumor

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Trial Information

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


The primary purpose of this study is to determine if treatment with ramucirumab causes
prolongation of the QTc/QT interval in patient with advanced cancer, to assess the safety
and tolerability of ramucirumab therapy, and to evaluate the PK characteristics of
ramucirumab


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

QT/QTc interval prolongation in participants

Outcome Time Frame:

Approximately 10 weeks

Safety Issue:

No

Principal Investigator

E-mail: ClinicalTrials@ ImClone.com

Investigator Role:

Study Director

Investigator Affiliation:

ImClone LLC

Authority:

United States: Institutional Review Board

Study ID:

13915

NCT ID:

NCT01017731

Start Date:

November 2009

Completion Date:

July 2013

Related Keywords:

  • Cancer
  • Solid Tumor
  • Advanced Solid tumor
  • Antibodies, Monoclonal
  • QTc
  • Metastatic
  • Malignant

Name

Location

ImClone Investigational SiteAtlanta, Georgia  30318
ImClone Investigational SiteNew Orleans, Louisiana  70121
ImClone Investigational SiteYpsilanti, Michigan  48198
ImClone Investigational SiteDallas, Texas  75230
ImClone Investigational SitePhiladelphia, Pennsylvania  19107
ImClone Investigational SiteSeattle, Washington  98104
ImClone Investigational SiteProvidence, Rhode Island  02903