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 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT01079702
Eligibility Criteria:
Inclusion Criteria:
* Patients with histological or cytological confirmed malignancies
* Measurable lesion according to RECIST criteria (only for the phase II part of the study)
* ECOG / WHO performance status of 0-2
* Age ≥ 18 years
* Life expectancy of at least 3 months
* Minimal acceptable safety laboratory values defined as:
* WBC ≥ 3.0 x 109 /L
* Platelet count ≥ 100 x 109 /L
* Hepatic function as defined by serum bilirubin ≤ 1.5 x ULN, ALT or AST ≤ 2.5 x ULN, in case of liver metastases ≤ 5 x ULN
* Renal function as defined by creatinine \< 150μmol/L
* Able and willing to give written informed consent
* Able to swallow and retain oral medication
* Able and willing to undergo blood sampling for pharmacokinetic and pharmacogenetic analysis
* Mentally, physically and geographically able to undergo treatment and follow up.
Exclusion Criteria:
* Patients with known alcoholism, drug addiction and/or psychotic disorders in the history that are not suitable for adequate follow up
* Women who are pregnant or breast feeding
* Women of childbearing potential who refuse to use a reliable contraceptive method throughout the study
* Serious concomitant systemic disorder that would compromise the safety of the patient, at the discretion of the investigator
* Any other medical condition that would interfere with study procedures and/or decrease safety of the protocol treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01079702
Study Brief:
Protocol Section:
NCT01079702