Phase II Clinical Trial of PLX038 in Patients With Platinum-Resistant Ovarian, Primary Peritoneal, and Fallopian Tube Cancer
Mayo Clinic
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.
Description
PRIMARY OBJECTIVE: I. To estimate the overall tumor response rate (overall response rate \[ORR\], that is, complete response \[CR\] + partial response \[PR\], according to Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v1.1\] of PLX038 in the setting of metastatic platinum resistant high grade serous ovarian cancer. SECONDARY OBJECTIVES: I. To estimate the progression-free survival and overall survival of treatment with PLX038. II. To describe and assess tolerability of PLX038. III. Measure PLX038 induced tumor TOP1-deoxyribonucleic acid (DNA) covalent complexes (TOP1cc)…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- ProcedureBiopsy
Undergo biopsy
- DrugPegylated SN-38 Conjugate PLX038
Given IV
- ProcedureComputed Tomography
Undergo CT
- ProcedureBiospecimen Collection
Undergo blood and stool sample collection
Location
- Mayo ClinicRochester, Minnesota