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Topoisomerase I inhibitor

PLX038 for Ovarian Cancer

Phase 2
Recruiting
Led By Scott H. Kaufmann, M.D., Ph.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
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
Must not have
Histology other than high grade serous carcinoma
Chemotherapy =< 4 weeks prior to registration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial tests PLX038, a drug that stops cancer cell growth, in patients with advanced ovarian, primary peritoneal, and fallopian tube cancers. The drug aims to shrink tumors by blocking enzymes needed for cancer cells to multiply.

Who is the study for?
This trial is for adults with high-grade serous ovarian, primary peritoneal, or fallopian tube cancer that's spread and resistant to platinum-based therapy. Participants need measurable disease, a life expectancy of at least 12 weeks, decent physical function (ECOG PS 0-2), acceptable blood counts and organ function. They must not have had more than one prior treatment for resistant disease and be willing to undergo biopsies.
What is being tested?
The trial is testing PLX038, a pegylated SN-38 conjugate designed to shrink tumors in metastatic cancers by blocking enzymes needed for cell growth. It includes CT scans and biospecimen collection like blood draws and tumor biopsies to study the drug's effects.
What are the potential side effects?
While specific side effects of PLX038 are not listed here, similar chemotherapy drugs can cause fatigue, nausea, diarrhea, low blood counts increasing infection risk; liver enzyme changes; allergic reactions; hair loss; mouth sores.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My ovarian cancer came back and no longer responds to platinum-based treatments.
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I am 18 years old or older.
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I am able to care for myself and perform daily activities.
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My condition allows for two tissue samples to be safely taken.
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I have been diagnosed with a specific type of ovarian cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer is not high grade serous carcinoma.
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I haven't had chemotherapy in the last 4 weeks.
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I do not have severe heart issues, uncontrolled diseases, or infections like HIV or hepatitis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of confirmed tumor responses
Secondary study objectives
Incidence of adverse event rates
Overall survival (OS)
Progression-free survival (PFS)
Other study objectives
Correlative analyses
Gut microbiome analysis
Homologous recombination (HR) status
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (pegylated SN-38 conjugate PLX038)Experimental Treatment4 Interventions
Patients receive PLX038 IV over 1 hour on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, biopsy, as well as blood and stool sample collection during screening and on the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1090
Computed Tomography
2017
Completed Phase 2
~2740
Biospecimen Collection
2004
Completed Phase 3
~2020

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Fallopian Tube Carcinoma often involve agents that inhibit tumor cell growth by targeting essential enzymes or cellular pathways. For example, pegylated SN-38 conjugate PLX038 works by blocking enzymes necessary for cell growth, thereby preventing tumor proliferation. Other treatments, such as platinum-based chemotherapies (e.g., carboplatin) and taxanes (e.g., paclitaxel), disrupt DNA replication and cell division. These mechanisms are crucial for patients because they directly target the rapid and uncontrolled growth of cancer cells, aiming to reduce tumor size and spread, ultimately improving patient outcomes.
Paclitaxel, Carboplatin and 1,25-D3 Inhibit Proliferation of Endometrial Cancer Cells <i>In Vitro</i>.Endometrial Cancers Harboring Mutated Fibroblast Growth Factor Receptor 2 Protein Are Successfully Treated With a New Small Tyrosine Kinase Inhibitor in an Orthotopic Mouse Model.Preclinical antitumor activity of a nanoparticulate SN38.

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,333 Previous Clinical Trials
3,060,132 Total Patients Enrolled
10 Trials studying Ovarian Cancer
3,508 Patients Enrolled for Ovarian Cancer
National Cancer Institute (NCI)NIH
13,917 Previous Clinical Trials
41,014,422 Total Patients Enrolled
289 Trials studying Ovarian Cancer
76,483 Patients Enrolled for Ovarian Cancer
Scott H. Kaufmann, M.D., Ph.D.Principal InvestigatorMayo Clinic in Rochester
~23 spots leftby May 2027