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:
2025-12-26 @ 5:19 PM
Ignite Modification Date:
2025-12-26 @ 5:19 PM
NCT ID:
NCT01121406
Eligibility Criteria:
Inclusion criteria:
1. Confirmed recurrent epithelial ovarian carcinoma, peritoneal carcinoma or fallopian tube carcinoma.
2. Platinum resistant or platinum refractory disease.
3. Eastern Collaborative Oncology Group performance status \< = 2.
4. Life expectancy \> = 3 months.
5. At least one measurable lesion (Response Evaluation Criteria In Solid Tumours version 1.1).
6. Adequate hepatic, renal and bone marrow functions.
7. signed written informed consent prior to admission to the study.
Exclusion criteria:
1. Contre-indications for cytotoxic treatment according to the Summary of Product Characteristics (Arm B).
2. Clinical evidence of active brain metastasis or leptomeningeal involvement.
3. Other malignancy currently requiring active therapy.
4. QTc prolongation according to Fridericia formula deemed clinically relevant by the investigator (e.g., congenital long QT syndrome, QTc according to Fridericia formula \> 470 ms).
5. Hypersensitivity to one of the trial drugs or the excipients.
6. Serious illness or concomitant non- oncological disease.
7. Systemic anticancer therapy within 4 weeks before the start of the study.
8. Evidence of ileus sor sub ileus.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01121406
Study Brief:
Protocol Section:
NCT01121406