About this trial
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
Qualifiers
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
Disqualifiers
Pregnant persons
Nursing persons
Persons of childbearing potential who are unwilling to employ adequate contraception
Histology other than high grade serous carcinoma
Trial design
Treatments tested in this trial
- Biopsy
- Pegylated SN-38 Conjugate PLX038
- Computed Tomography
- Biospecimen Collection
Treatment groups
Sponsors and collaborators
Mayo Clinic
Lead sponsor
National Cancer Institute (NCI)
Collaborator