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 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT00677105
Eligibility Criteria:
Inclusion Criteria:
* Confirmed solid malignancy or lymphoma that is metastatic or unresectable, and for which standard curative or palliative measures do not exist or are no longer effective
* Performance status (based on the Eastern Cooperative Oncology Group assessments) of \<= 2
* Life expectancy \> 3 months
* Adequate gastrointestinal absorption status
* Adequate liver, kidney and bone marrow function
* Adequate heart function (Left Ventricular Ejection Fraction \>= 50%)
Exclusion Criteria:
* Known brain metastases
* Chemotherapy (in the case of nitrosoureas and mitomycin C within 6 weeks), radiotherapy, immunotherapy or treatment with an investigational agent within 4 weeks before study drug administration
* History of uncontrolled heart disease or uncontrolled arterial hypertension (protocol-defined)
* Patients taking medications known to have a risk of causing heart function abnormalities (i.e.
* QTc prolongation and Torsades de Pointes)
* Neuropathy (malfunction of the nerves) at baseline of Grade \> = 2
* Positive serology for Hepatitis B, Hepatitis C or human immunodeficiency virus (HIV)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00677105
Study Brief:
Protocol Section:
NCT00677105