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NCT03531827 · ClinicalTrials.gov registry record · Phase 2
Combining CRLX101, a Nanoparticle Camptothecin, With Enzalutamide in People With Progressive Metastatic Castration Resistant Prostate Cancer Following Prior Enzalutamide Treatment
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
NCT03531827: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT03531827 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 4 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03531827, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
Study Summary
Background: Some prostate cancer keeps growing even when testosterone in the body drops to very low levels. This is called castrate-resistant prostate cancer. One treatment is enzalutamide. This is a modern hormonal therapy. But it only works for a certain amount of time and then the cancer becomes resistant to it. Researchers want to see if adding the treatment CRLX101 (formerly IT-101) could make enzalutamide work again for people who have already had it. Objective: To test a new way of treating prostate cancer using CRLX101 plus enzalutamide in people with certain prostate cancer who already had enzalutamide treatment. Eligibility: Adults ages 18 years and older with metastatic, castration-resistant prostate cancer who have had enzalutamide treatment Design: Participants will be screened with a medical history and physical exam. They will have blood and urine tests. They will have a scan of the chest/abdomen/pelvis. They will have a bone scan. Participants will get treatment in cycles. A cycle lasts 28 days. They will take enzalutamide by mouth once a day. They will get CRLX101 through an intravenous (IV) every 1 or 2 weeks. Participants will repeat screening tests throughout the study. Participants will have a follow-up visit 3-4 weeks after they stop taking the study drug. They will repeat most screening tests and have an electrocardiogram.
Interventions
- DRUG enzalutamide
- DRUG CRLX101
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2019-03-26 |
| Est. Completion | 2021-06-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03531827
The ClinicalTrials.gov registry entry for NCT03531827 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which enzalutamide is the first listed.
NCT03531827 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03531827 about?
NCT03531827 is a clinical study titled "Combining CRLX101, a Nanoparticle Camptothecin, With Enzalutamide in People With Progressive Metastatic Castration Resistant Prostate Cancer Following Prior Enzalutamide Treatment". Background: Some prostate cancer keeps growing even when testosterone in the body drops to very low levels. This is called castrate-resistant prostate cancer. One treatment is enzalutamide. This is a modern hormonal therapy. But it only works for a certain amount of time and then the cancer becomes...
What is the current status of trial NCT03531827?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2019-03-26. Estimated completion is 2021-06-01.
What interventions are being tested in trial NCT03531827?
The interventions under investigation include: enzalutamide (DRUG), CRLX101 (DRUG).
Who is sponsoring clinical trial NCT03531827?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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