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NCT05465941 · ClinicalTrials.gov registry record · Phase 2
PLX038 for Treatment of Metastatic Platinum-resistant Ovarian, Primary Peritoneal, and Fallopian Tube Cancer
A Phase 2 study of Platinum-Resistant Ovarian Carcinoma and Platinum-Resistant Fallopian Tube Carcinoma, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
- 1
- Study location
NCT05465941: Recruiting Phase 2 study of Platinum-Resistant Ovarian Carcinoma and Platinum-Resistant Fallopian Tube Carcinoma, sponsored by Mayo Clinic.
NCT05465941 is a Phase 2 study of Platinum-Resistant Ovarian Carcinoma and Platinum-Resistant Fallopian Tube Carcinoma that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 43 participants, roughly in line with the 42-participant average among 13 other Platinum-Resistant Ovarian Carcinoma trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05465941, a Phase 2 study of Platinum-Resistant Ovarian Carcinoma and Platinum-Resistant Fallopian Tube Carcinoma, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
- 1
- Study location
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 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.
Primary Outcome
A confirmed tumor response is defined to be either a complete response or partial response noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. Confirmed tumor response will be evaluated using the first 6 cycles of treatment. All patients meeting the eligibility criteria who have signed a consent form, have begun treatment, and who have had at least one post-baseline tumor assessment will be evaluable for response. Patients not having met the criteria of having one
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy
- DRUG Pegylated SN-38 Conjugate PLX038
Study Locations (1)
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2022-09-14 |
| Est. Completion | 2031-12-31 |
| Phase | Phase 2 |
What NCT05465941 shows while recruiting
NCT05465941 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, roughly in line with the 42-participant average among 13 other Platinum-Resistant Ovarian Carcinoma trials with a reported enrollment target.
The record links to 6 conditions, with Platinum-Resistant Ovarian Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Biospecimen Collection is the first listed.
NCT05465941 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT05465941 about?
NCT05465941 is a clinical study titled "PLX038 for Treatment of Metastatic Platinum-resistant Ovarian, Primary Peritoneal, and Fallopian Tube Cancer". 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 ...
What is the current status of trial NCT05465941?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2022-09-14. Estimated completion is 2031-12-31.
What conditions does trial NCT05465941 study?
This clinical trial studies the following conditions: Platinum-Resistant Ovarian Carcinoma, Platinum-Resistant Fallopian Tube Carcinoma, Platinum-Resistant Primary Peritoneal Carcinoma, Stage IV Ovarian Cancer AJCC v8, Stage IV Fallopian Tube Cancer AJCC v8.
What interventions are being tested in trial NCT05465941?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy (PROCEDURE), Pegylated SN-38 Conjugate PLX038 (DRUG).
Who is sponsoring clinical trial NCT05465941?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05465941 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05465941's enrollment target sits among peer trials
43 5th of 13 higher than 9 of 13 other Platinum-Resistant Ovarian Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Platinum-Resistant Ovarian Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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