Birinapant and Carboplatin in Treating Patients and Targeting Recurrent High Grade Ovarian, Fallo… (NCT02756130) | Clinical Trial Compass
WithdrawnPhase 1/2
Birinapant and Carboplatin in Treating Patients and Targeting Recurrent High Grade Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (HGSOC)
Stopped: funding was not secured
United States0Started 2018-08-01
Plain-language summary
This phase I/II trial studies how well birinapant and carboplatin work in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back. Drugs used in chemotherapy, such as birinapant and carboplatin work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* All patients must have measurable disease by imaging defined as tumor that can be measured \>= 10 mm with multiparametric magnetic resonance imaging (MRI) (primary modality of imaging) or computed tomography (CT) (as an alternative) or \>= 10 mm by caliper on physical examination
* Participant is capable of understanding and complying with parameters as outlined in the protocol and able to sign and date the informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to initiation of any screening or study-specific procedures
* The participant must have a histologic diagnosis of recurrent high grade serous ovarian cancer (ovarian, tubal, peritoneal), to be treated with chemotherapy
* Participants must have an image guided biopsy performed to yield fresh tissue for the in vitro organoid bio-assay and two biomarker testing (western blot and immunohistochemistry)
* Only patients with tumors that score positive in the in vitro organoid bio-assay will be enrolled in the clinical trial; patients with tumors that score negative in this bio-assay will be considered screening failures and will not be enrolled in the clinical trial
* Participant must have either no neuropathy (sensory and motor) or neuropathy less than or equal to grade 1
* The participant must have an Eastern Cooperative Oncology Group (ECOG) score between 0 - 2 at screening
* The participant must have a life expectancy of greater than 12 weeks
* Ab…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in percentage of cancer initiating cells
Timeframe: Baseline up to 2 years
2
Pharmacodynamic analysis of cellular inhibitor of apoptosis (cIAP) protein