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Topoisomerase I inhibitor

PLX038 for Ovarian Cancer

Q: Are there any available opportunities to partake in this research?

Affirmative. According to the information posted on clinicaltrials.gov, this medical research is still recruiting participants as of September 14th 2022 - first announced by the team in charge back on July 22nd 2022. A total of 31 patients are needed for participation at a single site.

Q: What data exists to support the safety of Pegylated SN-38 Conjugate PLX038 for human use?

Considering the lack of efficacy data, Pegylated SN-38 Conjugate PLX038 is estimated to have a safety rating of 2.

Q: How many volunteers can take part in this trial at maximum capacity?

Yes, a quick perusal of clinicaltrials.gov confirms that this medical investigation is presently seeking volunteers. Initially posted on July 22nd 2022 and last edited September 14th 2022, the trial needs to enlist 31 subjects from one centre.

Phase 2

Recruiting

Led By Andrea E. Wahner Hendrickson, M.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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is testing PLX038, a drug that may stop the growth of ovarian, primary peritoneal, and fallopian tube cancer cells, by blocking some of the enzymes needed for cell growth.

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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of confirmed tumor responses

Secondary outcome measures

Incidence of adverse event rates

Overall survival (OS)

Progression-free survival (PFS)

Other outcome measures

Correlative analyses

Gut microbiome analysis

Homologous recombination (HR) status

+2 more

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

~2720

Biospecimen Collection

2004

Completed Phase 2

~1730

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,210 Previous Clinical Trials

3,766,930 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,664 Previous Clinical Trials

40,925,963 Total Patients Enrolled

23 Trials studying Fallopian Tube Carcinoma

6,798 Patients Enrolled for Fallopian Tube Carcinoma

Andrea E. Wahner Hendrickson, M.D.Principal InvestigatorMayo Clinic in Rochester

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available opportunities to partake in this research?

"Affirmative. According to the information posted on clinicaltrials.gov, this medical research is still recruiting participants as of September 14th 2022 - first announced by the team in charge back on July 22nd 2022. A total of 31 patients are needed for participation at a single site."

Answered by AI

What data exists to support the safety of Pegylated SN-38 Conjugate PLX038 for human use?

"Considering the lack of efficacy data, Pegylated SN-38 Conjugate PLX038 is estimated to have a safety rating of 2."

Answered by AI

How many volunteers can take part in this trial at maximum capacity?

"Yes, a quick perusal of clinicaltrials.gov confirms that this medical investigation is presently seeking volunteers. Initially posted on July 22nd 2022 and last edited September 14th 2022, the trial needs to enlist 31 subjects from one centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "PLX038 for Treatment of Metastatic Platinum-resistant Ovarian, Primary Peritoneal, and Fallopian Tube Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05465941.

All > Fallopian Tube Cancer