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NCT01949519 · ClinicalTrials.gov registry record · Phase 1
Docetaxel and Lycopene in Metastatic Prostate Cancer
A Phase 1 study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01949519 is a Phase 1 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 24 participants.
The verdict
NCT01949519, a Phase 1 study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
Docetaxel is the standard, first-line chemotherapeutic agent for castrate resistant prostate cancer. While it has clinically useful activity, there is a strong need for substantial improvement in its efficacy. Possible ways for improving docetaxel monotherapy would be to combine it with an agent that either minimized toxicity (thus allowing higher doses) or improves efficacy (by targeting synergistic pathways). Lycopene is an attractive agent for combination with docetaxel because of its known accumulation in prostate tissue, its low toxicity, and its ability to inhibit signaling through the IGF-1 axis, and to reduce IL6 levels. Lycopene is highly synergistic with docetaxel at inhibiting the growth of prostate cancer in mice. The purpose of this study is to determine the maximum tolerated dose (MTD) of lycopene given in combination with docetaxel. This dose can then be used for subsequent phase II or phase III studies. New findings from the ECOG E3805 study presented at ASCO 2014, showed that concurrent chemotherapy with first-line ADT for newly diagnosed metastatic prostate cancer markedly improved overall survival compared with delayed or no chemotherapy. These subjects could also benefit from intervention to increase docetaxel effectiveness.
Interventions
- DRUG Lycopene and Docetaxel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2013-11 |
| Est. Completion | 2017-07-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01949519
The ClinicalTrials.gov registry entry for NCT01949519 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical University of South Carolina, which has 755 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Lycopene and Docetaxel is the first listed.
NCT01949519 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01949519 about?
NCT01949519 is a clinical study titled "Docetaxel and Lycopene in Metastatic Prostate Cancer". Docetaxel is the standard, first-line chemotherapeutic agent for castrate resistant prostate cancer. While it has clinically useful activity, there is a strong need for substantial improvement in its efficacy. Possible ways for improving docetaxel monotherapy would be to combine it with an agent tha...
What is the current status of trial NCT01949519?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2013-11. Estimated completion is 2017-07-12.
What interventions are being tested in trial NCT01949519?
The interventions under investigation include: Lycopene and Docetaxel (DRUG).
Who is sponsoring clinical trial NCT01949519?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
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