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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 is a Phase 1 study that was terminated before completion, run by NYU Langone Health. The registered enrollment target is 18 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03837353
The ClinicalTrials.gov registry entry for NCT03837353 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Docetaxel is the first listed.
NCT03837353 reports 0 study locations.
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.
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