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NCT03737370 · ClinicalTrials.gov registry record · Phase 1
Fractionated Docetaxel and Radium 223 in Metastatic Castration-Resistant Prostate Cancer
A Phase 1 study, sponsored by Tufts Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
NCT03737370: Completed Phase 1 study, sponsored by Tufts Medical Center.
NCT03737370 is a Phase 1 study that has completed, run by Tufts Medical Center. The registered enrollment target is 43 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03737370, a Phase 1 study, has completed, sponsored by Tufts Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
Study Summary
The objective of this study is to determine the maximum safe dose of Ra-223 in combination with fractionated (split doses) docetaxel when given to subjects and to determine the best administering dose. The study will look at side effects that may happen while taking the combination treatment. A total of approximately 18 subjects will take part in the dose escalation part of the study and an additional 25 subjects will participate in the expansion cohort. This study will be conducted across four centers in the United States.
Primary Outcome
DLT is defined as a subject in any cohort experiencing any of the following adverse events during cycle 1 of treatment, until cycle 2 day 1 of treatment: Thrombocytopenia (platelets \< 75 x 10\^9/L on C1D15 or \< 100 x 10\^9/L on C2D1), Neutropenia (ANC \< 1000 K/mL on C1D15 or ANC \< 1500 K/mL on C2D1), Grade 3 (by CTCAE v4) fatigue lasting ≥ 7 days, other non-hematologic toxicity ≥ grade 3, lasting ≥ 48 hours at least possibly related to treatment, or any toxicity (non-hematologic or hematolog
Interventions
- DRUG Docetaxel
- RADIATION Radium 223
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2018-01-30 |
| Est. Completion | 2025-09-30 |
| Phase | Phase 1 |
What the finished NCT03737370 record still lists
NCT03737370 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 2 interventions - of which Docetaxel is the first listed.
NCT03737370 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03737370 about?
NCT03737370 is a clinical study titled "Fractionated Docetaxel and Radium 223 in Metastatic Castration-Resistant Prostate Cancer". The objective of this study is to determine the maximum safe dose of Ra-223 in combination with fractionated (split doses) docetaxel when given to subjects and to determine the best administering dose. The study will look at side effects that may happen while taking the combination treatment. A tota...
What is the current status of trial NCT03737370?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2018-01-30. Estimated completion is 2025-09-30.
What interventions are being tested in trial NCT03737370?
The interventions under investigation include: Docetaxel (DRUG), Radium 223 (RADIATION).
Who is sponsoring clinical trial NCT03737370?
This trial is sponsored by Tufts Medical Center, which has 169 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03737370's enrollment target sits among peer trials
43 1100th of 2000 higher than 896 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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