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:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
NCT ID:
NCT00920205
Eligibility Criteria:
Inclusion Criteria:
* recurrent cancer refractory to available systemic therapy
* 18 years old or older
* predicted life expectancy equal or greater to 8 weeks
* at least 4 weeks post chemotherapy, immunotherapy, surgery, or radiation therapy and have recovered from treatment toxicities
* Karnofsky Performance Status equal or greater to 60 or ECOG equal or less than 2
* adequate organ function based on hematological, liver, and renal function
* LVEF greater than the lower limit of normal for the institution, as measured by MUGA or by echocardiography
* wash-out period before first dose os study drug if a protocol prohibited medication is being discontinued
Exclusion Criteria:
* pregnant or breastfeeding
* received any other anti-cancer treatment or investigational therapy within 28 days prior to Cycle 1 Day 1
* symptoms of heart failure equal or greater to Class III (by NYHA criteria)
* impaired cardiac function or clinically significant cardiac diseases
* concurrent treatment with medications that either markedly induce or inhibit CYP3A4
* concurrent treatment with medications that have a relative risk of prolonging the QT interval or inducing torsades de pointes if treatment cannot be discontinued or switched to a different medication prior to study drug
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00920205
Study Brief:
Protocol Section:
NCT00920205