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NCT03837353 · ClinicalTrials.gov registry record · Phase 1
A Parallel Arm Phase 1b/2a Study of DKN-01 as Monotherapy or in Combination With Docetaxel for the Treatment of Advanced Prostate Cancer With Elevated DKK1
A Phase 1 study, sponsored by NYU Langone Health.
- Terminated
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT03837353: Clinical Trial Phase 1 study, sponsored by NYU Langone Health.
NCT03837353 is a Phase 1 study that was terminated before completion, run by NYU Langone Health. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03837353, a Phase 1 study, was terminated before completion, sponsored by NYU Langone Health.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
This is a non-randomized multi-center Phase 1b/2a dose escalation and dose expansion study testing DKN-01 as monotherapy or in combination with docetaxel in metastatic castration-resistant prostate cancer. Patients need to be biomarker positive (Dickkopf-1 \[DKK1\]) either in plasma or biopsy. Other biopsies for correlative studies are encouraged but not mandatory. Pharmacokinetic (PK) testing of one pre-treatment blood sample and one post-treatment blood sample will be mandatory on Day 1 of every cycle.
Primary Outcome
Measured among Phase I dose-escalation cohorts (arms 1A.1, 1A.2, 2A.1, and 2A.2) only.
Interventions
- DRUG Docetaxel
- DRUG DKN-01
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2019-04-01 |
| Est. Completion | 2022-09-20 |
| Phase | Phase 1 |
Why NCT03837353 stopped before completion
NCT03837353 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Docetaxel is the first listed.
NCT03837353 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03837353 about?
NCT03837353 is a clinical study titled "A Parallel Arm Phase 1b/2a Study of DKN-01 as Monotherapy or in Combination With Docetaxel for the Treatment of Advanced Prostate Cancer With Elevated DKK1". This is a non-randomized multi-center Phase 1b/2a dose escalation and dose expansion study testing DKN-01 as monotherapy or in combination with docetaxel in metastatic castration-resistant prostate cancer. Patients need to be biomarker positive (Dickkopf-1 \[DKK1\]) either in plasma or biopsy. Other...
What is the current status of trial NCT03837353?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2019-04-01. Estimated completion is 2022-09-20.
What interventions are being tested in trial NCT03837353?
The interventions under investigation include: Docetaxel (DRUG), DKN-01 (DRUG).
Who is sponsoring clinical trial NCT03837353?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03837353's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 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
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