Treatment (pegylated SN-38 conjugate PLX038) for Stage IV Primary Peritoneal Cancer AJCC v8

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Mayo Clinic, Rochester, MN
Stage IV Primary Peritoneal Cancer AJCC v8+10 More
Pegylated SN-38 Conjugate PLX038 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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 to other places in the body. PLX038 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Eligible Conditions

  • Stage IV Primary Peritoneal Cancer AJCC v8
  • Platinum-Resistant Ovarian Carcinoma
  • Platinum-Resistant Primary Peritoneal Carcinoma
  • Recurrent Ovarian Carcinoma
  • Platinum-Resistant Fallopian Tube Carcinoma
  • Stage IV Fallopian Tube Cancer AJCC v8
  • Stage IV Ovarian Cancer AJCC v8

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Stage IV Primary Peritoneal Cancer AJCC v8

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Up to 5 years

Year 5
Overall survival (OS)
Year 5
Progression-free survival (PFS)
Up to 30 days
Incidence of adverse event rates
Up to 5 years
Correlative analyses
Day 21
Homologous recombination (HR) status
Protein expression
TOP1-deoxyribonucleic acid covalent complexes (TOP1cc)
Day 21
Proportion of confirmed tumor responses

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Stage IV Primary Peritoneal Cancer AJCC v8

Trial Design

1 Treatment Group

Treatment (pegylated SN-38 conjugate PLX038)
1 of 1
Experimental Treatment

31 Total Participants · 1 Treatment Group

Primary Treatment: Treatment (pegylated SN-38 conjugate PLX038) · No Placebo Group · Phase 2

Treatment (pegylated SN-38 conjugate PLX038)Experimental Group · 2 Interventions: Pegylated SN-38 Conjugate PLX038, Biopsy · Intervention Types: Drug, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1120

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
Closest Location: Mayo Clinic · Rochester, MN
Photo of jacksonville mayo clinic  1Photo of jacksonville mayo clinic  2Photo of jacksonville mayo clinic  3
1989First Recorded Clinical Trial
1 TrialsResearching Stage IV Primary Peritoneal Cancer AJCC v8
2165 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
PLX038 is a new drug that is being developed for the treatment of acute coronary syndrome
You have histological confirmed high grade serous ovarian cancer consistent with ovarian, fallopian tube, or primary peritoneal carcinoma.
You 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).
You have had no more than one prior line of therapy for platinum resistant disease.
The tumor must be measurable by the standard of reference (RECIST 1.1).
You have a disease that is amenable to two biopsies.
Hemoglobin > 8.0 g/dL (obtained =< 28 days prior to registration).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.