Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT01413451
Eligibility Criteria:
* INCLUSION CRITERIA:
* Female or male subjects, greater than or equal to 18 years of age.
* Histologically-confirmed diagnosis of pancreatic adenocarcinoma, mesothelioma, mesothelin-positive ovarian cancer, or NSCLC. A new biopsy is not required; the diagnostic biopsy sample will be sufficient. IHC confirmation of mesothelin-positivity is not necessary for pancreatic adenocarcinoma and mesothelioma as nearly 100% of pancreatic adenocarcinomas and mesotheliomas express mesothelin. Mesothelin expression in ovarian cancer and NSCLC will be tested by IHC and any degree of positivity (1+, 2+, or 3+) will be accepted.
* Subjects are required to have measurable disease that has progressed through prior therapy and that includes a non-hepatic lesion for imaging that is greater than or equal to 1.5 cm, as defined by Modified Response Evaluation Criteria in Solid Tumors (RECIST).
* Eastern Cooperative Oncology Group (ECOG) performance status or 0, 1, or 2.
* Female subjects of childbearing potential and all male subjects are required to consent to use a medically acceptable method of contraception throughout the study period and for 30 days after amatuximab administration. A barrier method of contraception is required.
* Laboratory and clinical results within the 2 weeks prior to Day of Infusion as follows:
* Absolute neutrophil count (ANC): greater than or equal to 1.5 times 10(9)/L
* Platelet count: greater than or equal to 75 times 10(9)/L
* Hemoglobin: greater than or equal to 9 g/dL
* Serum bilirubin: less than or equal to 1.5 mg/dL
* Aspartate transaminase (AST): less than or equal to 3 x upper limit of normal (ULN) (less than or equal to 5 ULN acceptable for pancreatic patients with known liver metastasis only)
* Alanine transaminase (ALT) less than or equal to 3 times upper limit of normal (ULN) (less than or equal to 5 ULN acceptable for pancreatic patients with known liver metastasis only)
* Alkaline Phosphatase less than or equal to 5 times ULN
* Serum creatinine less than or equal to 1.5 mg/dL
* Subjects are required to be willing and able to provide written informed consent.
EXCLUSION CRITERIA:
* Subjects are ineligible to participate in this study if any of the following criteria are met:
* Known allergy or hypersensitivity to monoclonal antibodies;
* Prior treatment with amatuximab;
* Prior treatment with SS1(dsFv)PE38 (SS1P);
* Known brain metastases;
* Known prosthetic devices that would prohibit imaging of lesion of interest due to radiographic artifact;
* Evidence of other active malignancy requiring treatment;
* Clinically significant heart disease (e.g., congestive heart failure of New York Heart Association Class III or IV, angina not well controlled by medication, or myocardial infarction within 6 months);
* ECG demonstrating clinically significant arrhythmias. Subjects with chronic atrial arrhythmia, (i.e., atrial fibrillation or paroxysmal supraventricular tachycardia), are eligible;
* Active serious systemic disease, including active bacterial or fungal infection within 2 weeks before study entry;
* Active viral hepatitis or symptomatic human immunodeficiency virus (HIV) infection;
* Treatment within 3 months with immunomodulatory therapy (e.g., interferons, immunoglobulin therapy, Interleukin 1 receptor antagonist (IL-1RA) or systemic corticosteroids). Short-term systemic corticosteroids or topical or intra-articular steroids are acceptable, at the discretion of the Investigator;
* Chemotherapy, biologic therapy, radiation therapy or immunotherapy within 3 weeks prior to dosing with amatuximab;
* Breast-feeding, pregnant, or likely to become pregnant during the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT01413451
Study Brief:
Protocol Section:
NCT01413451