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 @ 2:42 PM
Ignite Modification Date:
2025-12-24 @ 2:42 PM
NCT ID:
NCT03188159
Eligibility Criteria:
Inclusion Criteria:
1. Provided written informed consent
2. Patients must have platinum resistant or refractory HGSOC; defined as progressive disease by imaging ≤ 6 months from last date of most recent platinum-based therapy or rising CA-125 based on GCIG criteria
3. Have histological confirmation of high-grade serous or high-grade endometrioid or undifferentiated tumour of the primary peritoneum, fallopian tube cancer or ovary
4. Molecular subtyping by Nanostring technology must confirm C5 subtype on primary ovarian surgical sample or a biopsy of recurrent disease
5. Patients must not have received more than 3 prior chemotherapy regimens, which may include chemotherapy, biologics or other targeted therapies (this does not include maintenance treatment or hormonal therapy) for platinum resistant disease
6. Measurable disease by RECIST criteria (version 1.1).
7. At time of registration, if the patient has had previous treatment it must have been at least 28 days since major surgery or radiation therapy; 28 days from any other previous anti-cancer therapy including biologics; 14 days since hormone therapy. Patients must have recovered to ≤ grade 1 from their treatment-related events with the exception of alopecia.
8. Age ≥ 18 years of age (Age ≥ 21 years of age for Singapore sites)
9. Have clinically acceptable laboratory screening results within certain limits specified below:
* AST and ALT ≤ 2.5 times upper limit of normal (ULN)
* Total bilirubin ≤ ULN
* Creatinine ≤ 1.5 x UL
* Absolute neutrophil count ≥ 1500 cells/mm
* Platelets ≥ 100,000/mm3
* Hemoglobin ≥ 9.0 g/dl
10. Have an ECOG performance status of ≤ 2.
11. Women of child-producing potential must agree to use effective contraceptive methods prior to study entry, during study participation, and for at least 30 days after the last administration of study medication.
12. Have the ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments.
13. Able to tolerate IV medication.
14. Life expectancy greater than 6 months
Exclusion Criteria:
1. Women who are pregnant or nursing
2. Previous exposure to vinorelbine
3. Patients known to be hypersensitive to vinorelbine or any vinca alkaloids previously
4. Persistent toxicities (≥ Common Terminology Criteria for Adverse Event (CTCAE) v4.0 grade 1) caused by previous cancer therapy, excluding alopecia
5. Have active, acute, or chronic clinically significant infections or bleeding.
6. Have active angina pectoris, stroke, myocardial infarction, or any other pre-existing uncontrolled cardiovascular condition within the last 6 months.
7. Have additional uncontrolled serious medical or psychiatric illness.
8. Require therapeutic doses of anti-coagulation with warfarin or warfarin derivatives. However, treatment with low molecular weight heparin (LMWH) is allowed.
9. Known symptomatic CNS metastases. Treated brain metastatis that are stable for more than ≥4 weeks are allowed.
10. Psychiatric disorders that would hinder compliance with study protocol
11. History of other malignancies within the past 5 years except for curatively treated skin BCC or SCC or cervical carcinoma in situ. Patients who have had curatively treated breast cancer, with completion of adjuvant chemotherapy more than three years before are allowed.
12. Require treatment with drugs known to be potent inducers or inhibitors of CYP3A4 at the time of registration
13. Subjects known to be HIV positive or with active and untreated Hepatitis B or Hepatitis C infection. Patients with controlled Hepatitis B or Hepatitis C infection on treatment with antiviral medication are allowed.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
21 Years
Maximum Age:
99 Years
Study:
NCT03188159
Study Brief:
Protocol Section:
NCT03188159