PLX038 for Treatment of Metastatic Platinum-resistant Ovarian, Primary Peritoneal, and Fallopian Tube Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

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

43 Participants
are divided into 1 treatment group

Sponsors and collaborators

Mayo Clinic

Lead sponsor

National Cancer Institute (NCI)

Collaborator