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 @ 7:12 PM
Ignite Modification Date:
2025-12-24 @ 7:12 PM
NCT ID:
NCT01204203
Eligibility Criteria:
Inclusion Criteria:
* Males and females \> 18 years of age
* Life expectancy of at least 2 months
* Histologically confirmed unresectable malignant pleural mesothelioma (MPM)
* Measurable disease by CT Scan criteria and/or positive metabolic activity of 18F-FDG PET Scan criteria at screening
* ECOG Performance Status of 0-2
* Laboratory and clinical results within 2 weeks prior to Day 1 must be as follows:
1. ANC ≥ 1.5 x 109/L
2. Platelet Count ≥ 100 x 109/L
3. Hemoglobin ≥ 9g/dL
4. Serum bilirubin ≤ 1.5 x upper limit of normal (ULN)
5. AST ≤ 2.5 x ULN
6. ALT ≤ 2.5 x ULN
7. ALK-P ≤ 3 x ULN
8. Serum creatinine ≤ 1.8mg/dL
9. Calculated Serum Creatinine Clearance 40 - \> 60ml/min
* Female subjects of childbearing potential and all male subjects must be surgically sterile or consent to use a medically acceptable method of contraception throughout the trial.
* Willing and able to provide written informed consent.
Exclusion Criteria:
* Known central nervous system (CNS) tumor involvement
* Evidence of other active malignancy requiring treatment
* Clinically significant heart disease (e.g., congestive heart failure of New York Heart Association Class 3 or 4 angina not well controlled by medication, or myocardial infarction within 6 months)
* Known infection with HIV or hepatitis
* Clinically significant arrhythmias demonstrated on electrocardiogram (ECG). Note: subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia (SVT) are eligible.
* Active, serious systemic disease, including active bacterial or fungal infection.
* Subjects undergoing invasive dental procedures, significant periodontal disease or history of osteonecrosis of the jaw.
* Treatment within 4 weeks of the start of the trial with other systemic anticancer therapy.
* Breastfeeding, pregnant, or likely to become pregnant during the clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT01204203
Study Brief:
Protocol Section:
NCT01204203