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 range18 Years
SexFEMALE
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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…
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