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 @ 1:37 PM
Ignite Modification Date:
2025-12-24 @ 1:37 PM
NCT ID:
NCT03446495
Eligibility Criteria:
Inclusion Criteria:
* Age\>18
* Histologically proven epithelial ovarian cancer
* ECOG 0-1
* Partially platinum sensitive relapsed ovarian cancer: platinum-free interval 6 -12 months
* With 1-2 or more cycles on trabectedin treatment at the recommended dose of 1.1mg/m2 q3w 3hr infusion in combination of PLD at 30mg/ml with appropriate pre-medication
* Prior treatment with 1 or more chemotherapy regimen
Exclusion Criteria:
* Platinum resistant disease: PFI \< 6 months (progression within six months after first-line platinum-based chemotherapy)
* Unwilling or unable to have a central venous catheter
* Patients with hepatic impairment (Patients with elevated bilirubin)
* Patients with renal impairment (Patients with serum creatinine \>1.5 mg/dL)
* Patients with hematologic impairment (baseline neutrophil counts of less than 1,500 cells/mm3 and platelets count of less than 100,000 cells/mm3)
* Patients with serious impaired cardiac function (patients with cardiac disease and with reduction of the QRS complex)
* AIDS-related Kaposi's sarcoma
* Lactation or pregnancy
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03446495
Study Brief:
Protocol Section:
NCT03446495