Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study, sponsored by Medical University of South Carolina.
NCT01949519 is a Phase 1 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01949519 record still lists
NCT01949519 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 1 intervention - of which Lycopene and Docetaxel is the first listed.
NCT01949519 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01949519's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02331979 · 24 participants · NA
Improving Bladder Function in SCI by Neuromodulation
- NCT03096197 · 24 participants · NA
Exoskeleton and Spinal Cord Stimulation for SCI
- NCT03223922 · 24 participants · NA
Neurocognitive Functioning With Genu-Sparing Whole Brain Radiation Therapy for Brain Metastases
- NCT03326921 · 24 participants · Phase 1
HA-1 T TCR T Cell Immunotherapy for the Treatment of Patients With Relapsed or Refractory Acute Leukemia After Donor Stem Cell Transplant
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia