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 @ 1:05 AM
Ignite Modification Date:
2025-12-25 @ 1:05 AM
NCT ID:
NCT01273493
Eligibility Criteria:
Inclusion Criteria:
* Patients with locally advanced or metastatic disease, any solid tumor except hepatocellular carcinoma, who have been previously treated with systemic chemotherapy (chemotherapy administered through the blood) and who have had relapsed or had progressive disease following standard of care treatment with chemotherapy prior to enrollment, or intolerant to prior standard of care treatment with chemotherapy
* Patients with Eastern Cooperative Oncology Group (ECOG) score of \<=2 at the time of screening
* Patients enrolled with hepatic dysfunction must have laboratory test results for total bilirubin of \>1.5x to \<=3x the upper limit of normal (ULN) and liver function tests (alanine aminotransferase \[ALT\] and aspartate aminotransferase \[AST\]) of \<8x the ULN
* Patients enrolled without hepatic dysfunction must have laboratory test results for total bilirubin of less than the ULN, alkaline phosphatase (ALP) \<=1.5x the ULN, and AST and ALT of \<=the ULN.
Exclusion Criteria:
* Patients with previous exposure to trabectedin
* Patients with known liver disease
* Patients diagnosed with hepatocellular carcinoma, or who have a history of biliary sepsis within the past 2 years
* Patients unwilling to have a central catheter
* In hepatic dysfunction group, patients with hepatic dysfunction who have Gilbert's syndrome. Patients signs of encephalopathy (altered brain function).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01273493
Study Brief:
Protocol Section:
NCT01273493