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:
2025-12-26 @ 10:33 AM
Ignite Modification Date:
2025-12-26 @ 10:33 AM
NCT ID:
NCT00412828
Eligibility Criteria:
Inclusion Criteria:
* Male or female with age ≥ 18 years.
* Progressive or new metastatic melanoma, stage III or IV.
* Measurable disease by CT / MRI
* Failure of no more than 1 line of prior cytotoxic therapy.
* Adequate bone marrow, renal and hepatic function
* Leukocytes ≥ 3000/mm3, ANC ≥ 1,500 cells/mm3, Platelets ≥ 100,000/mm3
* Hemoglobin ≥ 10 g/dL (transfusion allowed)
* Total bilirubin ≤ 1.5 x upper normal limit (UNL)
* AST (SGOT), ALT (SGPT) ≤ 3.0 x UNL (≤ 5.0 x UNL may be acceptable)
* Serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance \> 45 mL/min/1.73 m2
* PT/aPTT \< 1.5 x UNL or within therapeutic range via anti-coagulation therapy
* Karnofsky PS ≥ 70%.
* Estimated life expectancy \> 3 months.
* Signed informed consent approved IRB and ability to comply with the study or monitoring procedures.
* Subjects with evaluable disease are eligible in dose-escalation cohorts
Exclusion Criteria:
* Prior therapies for disease under study less than 4 weeks prior to enrollment.
* Major surgery or trauma within 4 weeks of enrollment.
* Active brain metastases
* Active chronic inflammatory, autoimmunity, immunodeficiency disease, and vascular or hemorrhagic disorders.
* History of allergic reactions to dolastatin, auristatin or compounds of similar composition.
* Significant cardiovascular disease
* Other malignancies
* Pregnancy or breast feeding
* Refusal or inability to use effective means of contraception (for men, and women with childbearing potential)
* History of or test-positive to HIV, or hepatitis B or C
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00412828
Study Brief:
Protocol Section:
NCT00412828