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IMCL 3Y12   |   12-649
A Study to Determine Whether Necitumumab (IMCL-11F8) Monotherapy Affects the Corrected QT (QTc) Interval in Patients with Advanced Solid Tumors

Disease(s)
Adrenal
Advanced Disease
All Cancer Types
Biliary
Bladder
Bone Cancer
Brain
Breast
Colorectal
Esophageal
Gastrointestinal Stromal Tumor (GIST)
Genitourinary
GI (Gastrointestinal)
Glioblastoma
Head & Neck
High Grade Glioma
Liver
Lung
Melanoma
Mesothelioma
Pancreas
Peritoneal
Prostate
Renal
Sarcoma
Solid Tumors
Spine
Thyroid
Urethral
Uterine
Hospital(s)
Main Campus
Phase(s)
Phase 1
Stage(s)
Type(s)
Therapeutic
Drug(s)
Necitumumab

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Description
Primary
  1. The primary objective of this study is to determine whether treatment with necitumumab monotherapy affects the QT/QTc interval among patients with advanced solid tumors refractory to standard treatment or for which no standard treatment is available.
Secondary
  1. To determine whether treatment with necitumumab affects other electrocardiographic parameters in this study population;
  2. To assess the safety, tolerability, and immunogenicity of necitumumab monotherapy;
  3. To evaluate the pharmacokinetic (PK) characteristics of necitumumab; and
  4. To evaluate the antitumor activity of necitumumab monotherapy in the treatment of advanced solid tumors (ie, tumor response per the Response Evaluation Criteria in Solid Tumors, Version 1.1 [RECIST 1.1]).

Inclusion Criteria
  1. Have documented advanced or metastatic malignant solid tumors (except for colorectal tumors with KRAS mutation) that have not responded to standard therapy or for which no standard therapy is available.
  2. May have measurable or non-measurable disease.
  3. Have resolution to Grade 0 or 1 (except where otherwise stated in this eligibility criteria) by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE 4.0) of all clinically significant toxic effects (other than alopecia) of prior chemotherapy, surgery, radiotherapy, or hormonal therapy with the exception of peripheral neuropathy, which must have improved to Grade ≤ 2
  4. Have an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1 at baseline (measured within 14 days prior to first dose of study therapy).
  5. Are ≥ 18 years of age.
  6. Have adequate hepatic function as defined by: a total bilirubin level ≤ 1.5 times the upper limit of normal (ULN); and aspartate transaminase (AST) and alanine transaminase (ALT) levels ≤ 3.0 times ULN [or 5.0 times ULN in the case of liver metastases].
  7. Have adequate hematologic function as defined by: an absolute neutrophil count (ANC) of ≥ 1500/mL; a hemoglobin level ≥ 9 g/dL (blood transfusions are permitted); and a platelet count ≥ 100,000/mL.
  8. Have potassium, magnesium, and calcium within normal limits (patients receiving electrolyte correction therapy are eligible if parameters are within normal limits at the time of assessment).
  9. Have adequate renal function as defined by a serum creatinine ≤ 1.2 times the ULN, or creatinine clearance (measured via 24-hour urine collection) ≥ 50 mL/min.
  10. Subjects, if female, are surgically sterile, postmenopausal, or compliant with a highly effective contraceptive method (failure rate < 1 percent) during and for 6 months after the treatment period (oral hormonal contraception alone is not considered highly effective and must be used in combination with a barrier method). If male, patients are surgically sterile or compliant with a highly effective contraceptive regimen during and for 6 months after the treatment period.
  11. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization.
  12. Are able to provide informed written consent and are amenable to compliance with protocol schedules and testing.

Exclusion Criteria
  1. Have received treatment within 28 days of the initial dose of study drug with an experimental agent for non-cancer indications that has not received regulatory approval for any indication.
  2. Are currently enrolled in, or discontinued within the 28 days prior to first dose of study therapy from, a clinical trial involving an anticancer investigational product or standard of care, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
  3. Had systemic anticancer therapy within 21 days (6 weeks for nitrosoureas or mitomycin C) prior to the first dose of study therapy.
  4. Had therapeutic radiotherapy within 14 days prior to the first dose of study therapy
  5. Have received necitumumab or any other monoclonal antibody targeting the EGFR as the most recent prior treatment.
  6. Have brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants. Patients who have undergone previous radiotherapy for brain metastases, who are now nonsymptomatic and no longer require treatment with steroids or anticonvulsants, are eligible.
  7. Have a clinically relevant abnormality on the ECG, preventing an accurate measurement of the QT interval.
  8. Have current clinically-relevant coronary artery disease or uncontrolled congestive heart failure (New York Heart Association II, III or IV).
  9. Have medically uncontrolled angina pectoris, or has experienced myocardial infarction within 6 months prior to the first dose of study therapy.
  10. Have an implantable pacemaker or automatic implantable cardioverter defibrillator.
  11. Have received sotalol within 10 days prior to the first dose of study therapy.
  12. Have a history of risk factors for ventricular tachycardia or Torsades de pointes (eg, family history [parents or siblings] of long QT syndrome), history of fainting, unexplained loss of consciousness, or convulsions.
  13. Have a history of additional risk factors for Torsades de pointes (eg, heart failure, congestive heart failure, myocardial infarction, cardiomyopathy, hypokalemia, hypoglycemia, or hypomagnesia).
  14. Have any evidence of conduction abnormality (eg, increased QRS complex).
  15. Have congenital long QT syndrome.
  16. Have a prolonged QTc interval mean on pretreatment ECG (mean > 450 msec) utilizing both Bazett�s and Fridericia�s correction (ie, the patient is not eligible if either one of the correction formulas demonstrate mean > 450 msec).
  17. Have a heart rate < 50 bpm or > 100 bpm at rest
  18. Are using a medication that is known to prolong the ECG QT interval, or have received a medication known to prolong the ECG QT interval within 14 days prior to first dose of study therapy.
  19. Have a known allergy / history of hypersensitivity reaction to any of the treatment components, including any ingredient used in the formulation of necitumumab, or a known history of severe (Grade 3-4) hypersensitivity reaction to any monoclonal antibody.
  20. Have an ongoing or active infection (requiring systemic treatment), including active tuberculosis or known infection with the human immunodeficiency virus.
  21. If female, are pregnant (confirmed by serum beta human chorionic gonadotropin test) or breastfeeding.
  22. Have known drug or alcohol abuse within 2 years prior to the first dose of study therapy
  23. Have a history of significant neurological or psychiatric disorders, including dementia, seizures, or bipolar disorder, potentially precluding protocol compliance.
  24. Have psychological, familial, sociological, or geographical conditions which do not permit adequate study follow-up, compliance with the protocol, or signature of Informed Consent.
  25. Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
  26. Are employees of ImClone or Eli Lilly and Company, Inc, or Bristol Meyers Squibb.

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