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 @ 12:37 PM
Ignite Modification Date:
2025-12-24 @ 12:37 PM
NCT ID:
NCT01357161
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed non-low grade, non-borderline (low malignant potential) ovarian, fallopian tube, or primary peritoneal cancer which has progressed after paclitaxel / platinum-based therapy.
* Platinum-sensitive disease. Radiological progression must have occurred 6 months or more after the completion of the most recent platinum-based treatment.
* Measurable disease.
* Available tumor sample(s).
* Performance status of ≤1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
* Adequate organ function.
Exclusion Criteria:
* Pregnancy or the intention to become pregnant during the course of the study.
* Participation in a study with an investigational compound or device within 28 days of receiving first dose of study medication.
* Active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Primary CNS tumor.
* Known hypersensitivity or contraindications to the components of potential study therapy (paclitaxel, carboplatin, adavosertib) or its analogs (i.e., cremophor, mannitol, etc.).
* Participant requires the use of medications or products that are metabolized by, or inhibit, or induce Cytochrome P450 3A (CYP3A4).
* Ongoing peripheral neuropathies ≥Grade 2 and related to previous treatment.
* Known psychiatric or substance abuse disorders.
* Regular use (including "recreational use") of any illicit drugs or recent history (within the last year) of drug or alcohol abuse.
* HIV positive.
* Active Hepatitis B or C.
* Symptomatic ascites or pleural effusion.
* Clinical history suggestive of Li Fraumeni Syndrome.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01357161
Study Brief:
Protocol Section:
NCT01357161