NCT05465941 PLX038 for Treatment of Metastatic Platinum-resistant Ovarian, Primary Peritoneal, and Fallopian Tube Cancer
| NCT ID | NCT05465941 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Mayo Clinic |
| Condition | Platinum-Resistant Fallopian Tube Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 43 participants |
| Start Date | 2022-09-14 |
| Primary Completion | 2027-02-15 |
Trial Parameters
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Brief Summary
This phase II trial tests whether pegylated SN-38 conjugate PLX038 (PLX038) works to shrink tumors in patients with ovarian, primary peritoneal, and fallopian tube cancers that has spread from where it first started (primary site) to other places in the body (metastatic). PLX038 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Eligibility Criteria
Inclusion Criteria: * Age \>= 18 years NOTE: Because no dosing or adverse event data are currently available on the use of PLX038 in patients \< 18 years of age, children are excluded from this study, but will be eligible for future pediatric trials * Histological confirmed high grade serous ovarian cancer consistent with ovarian, fallopian tube, or primary peritoneal carcinoma (NOTE: Any of these diseases are referred to in this protocol as "ovarian cancer") * Recurrent high grade serous ovarian cancer that was initially platinum sensitive (i.e., had at least one platinum-free interval of at least 6 months before progression) is now platinum resistant * No more than one prior line of therapy for platinum resistant disease. NOTE: Prior poly adenosine diphosphate-ribose polymerase (PARP) inhibitor therapy is allowed * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 * Disease that is amenable to two biopsies * Life expectancy greater \>= 12 weeks * Easter