Open-label Extension Study of NEOD001 in Subjects With Light Chain (AL) Amyloidosis
ID de estudio #: NCT02613182
condición: Amiloidosis AL
The rationale for this study is to provide additional treatment with NEOD001 for subjects who complete Study NEOD001-001, and to continue to evaluate long term safety and tolerability. All subjects in the current NEOD001 trials are being dosed at 24 mg/kg, which will be continued in this study.
última actualización: 17 de Septiembre de 2021
fecha de inicio: Febrero 2016
finalización estimada: Mayo 2018
última actualización: 16 de mayo de 2019
fase de desarrollo: la Fase 2 de ATLAS
tamaño / inscripción: 34
descripción del estudio: The rationale for this study is to provide additional treatment with NEOD001 for subjects who complete Study NEOD001-001, and to continue to evaluate long term safety and tolerability. All subjects in the current NEOD001 trials are being dosed at 24 mg/kg, which will be continued in this study. The primary objective of the study is to evaluate long-term safety and tolerability of NEOD001 and the secondary objectives are to assess the immunogenicity of NEOD001 and to incorporate serum NEOD001 concentrations in a population pharmacokinetic (PK) analysis.
- Long-term Safety and Tolerability of NEOD001
Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome, or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.
- From initiation of study drug through the last study visit or up to 30 days after date of last dose, whichever came first, assessed up to 24 months
criterios de inclusión:
• Sexos elegibles: todos
Previously enrolled and treated for at least 9 months in Study NEOD001-001
Ability to understand and willingness to sign an informed consent form prior to initiation of any study procedures
Has adequate bone marrow reserve, hepatic and renal function, as demonstrated by:
Absolute neutrophil count (ANC) ≥1.0 ×109/L
Platelet count ≥75 × 109/L
Hemoglobin ≥9 g/dL
Total bilirubin ≤2 times the upper limit of normal (× ULN)
Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤3 × ULN
Estimated glomerular filtration rate ≥30 mL/minute
Seated systolic blood pressure 90 to 180 mmHg
ECOG Performance Status 0 to 2
Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 28 days prior to the first administration of study drug and agree to use highly effective physician-approved contraception from 30 days prior to the first study drug administration to 90 days following the last study drug administration
Male subjects must be surgically sterile or must agree to use highly effective physician-approved contraception from 30 days prior to the first study drug administration to 90 days following the last study drug administration
Criterio de exclusión: Criterios:
Any new medical contraindication or clinically significant abnormality on physical, neurological, laboratory, vital signs, or electrocardiogram (ECG) examination (e.g., atrial fibrillation; with the exception of subjects for whom the ventricular rate is controlled) that precludes continued or initiation of treatment with NEOD001 or participation in the study
History of Grade ≥3 infusion-associated adverse events (AEs) or hypersensitivities to NEOD001 or any of its excipients
Treatment with any anticancer therapy (standard or investigational) within the 14 days prior to the first dose of study drug. In addition, subjects must have fully recovered (i.e., National Cancer Institute Common Terminology Criteria for Adverse Events [CTCAE] Grade 1 [exception: subjects with prior bortezomib may have CTCAE Grade 2 neuropathy]) from the clinically significant toxic effects of that treatment
Received any of the following within the specified time frame prior to the first administration of study drug:
Hematopoietic growth factors, transfusions of blood or blood products within 1 week
Major surgery within 2 weeks
Radiotherapy within 2 weeks
Transplant within 8 weeks
Investigational drug other than NEOD001 within 4 weeks
Another experimental anti-amyloid therapy other than NEOD001 within 2 years
Uncontrolled symptomatic orthostatic hypotension
Myocardial infarction, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia, within 6 months prior to the first dose of study drug
Secondary malignancy, with the exception of:
Carcinoma de células basales, carcinoma de células escamosas o cáncer de cuello uterino in situ adecuadamente tratado
Adequately treated stage I cancer from which the subject is currently in remission
Any other cancer from which the subject has been disease-free for ≥3 years
Uncontrolled human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection
Women who are lactating
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