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 @ 9:59 PM
Ignite Modification Date:
2025-12-24 @ 9:59 PM
NCT ID:
NCT00189332
Eligibility Criteria:
Inclusion Criteria:
* Advanced melanoma not responding to 1st line chemotherapy
* Histological evidence of melanoma
* Measurable disease according to RECIST criteria
* ECOG performance status less than or equal to 2
* Life expectancy 6 months or more
* Normal organ and bone marrow function as defined by hematological and serum chemistry limits
* Adequate contraception for females of childbearing potential
Exclusion Criteria:
* Stage IV disease which has previously progressed during interferon treatment.
* Restriction of some therapies/medications for a certain timeframe prior to enrollment and during the study including: investigational drugs, high dose corticosteroids, immunotherapy, immunosuppressive medications, radiotherapy and drugs known to prolong QT interval and/or induce Torsades De Pointes
* History of uncontrolled seizure disorders
* Uncontrolled coagulation disorders.
* History or evidence of myocardial ischemia, congestive heart failure or arrythmias requiring treatment in the past 6 months
* History of uncontrolled intercurrent or chronic illness
* Concurrent malignancies.
* Brain metastases.
* HIV positive.
* Prolonged QTc interval
* Uncontrolled intercurrent or chronic illnesses.
* Pregnant or lactating women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00189332
Study Brief:
Protocol Section:
NCT00189332