RecruitingPhase 2NCT05465941

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

Phase II Clinical Trial of PLX038 in Patients With Platinum-Resistant Ovarian, Primary Peritoneal, and Fallopian Tube Cancer


Sponsor

Mayo Clinic

Enrollment

43 participants

Start Date

Sep 14, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing PLX038, a new long-acting camptothecin chemotherapy drug, in women with platinum-resistant high-grade serous ovarian, fallopian tube, or primary peritoneal cancer. "Platinum-resistant" means the cancer stopped responding to standard platinum-based chemotherapy within 6 months of completing it, which narrows treatment options significantly. **You may be eligible if...** - You are 18 or older with confirmed high-grade serous ovarian, fallopian tube, or primary peritoneal carcinoma - Your cancer is platinum-resistant (progressed within 6 months of platinum-based chemotherapy) - You have measurable disease visible on imaging - Your kidney, liver, and blood count levels are adequate for treatment **You may NOT be eligible if...** - Your cancer is a different histology (not high-grade serous) - You have been previously treated with camptothecin-class drugs or certain other overlapping agents - You have significant nerve damage, serious heart problems, or other major organ issues Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiopsy

Undergo biopsy

DRUGPegylated SN-38 Conjugate PLX038

Given IV

PROCEDUREComputed Tomography

Undergo CT

PROCEDUREBiospecimen Collection

Undergo blood and stool sample collection


Locations(1)

Mayo Clinic

Rochester, Minnesota, United States

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NCT05465941


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