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NCT03208712 · ClinicalTrials.gov registry record · Early Phase 1
Radium-223 and Atezolizumab in Patients With Urothelial Carcinoma With Bone Metastases Who Have Had Disease Progression After Platinum-Based Chemotherapy
A Early Phase 1 study, sponsored by University of Michigan Rogel Cancer Center.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 1
- Enrollment target
NCT03208712: Clinical Trial Early Phase 1 study, sponsored by University of Michigan Rogel Cancer Center.
NCT03208712 is a Early Phase 1 study that was terminated before completion, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 1 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03208712, a Early Phase 1 study, was terminated before completion, sponsored by University of Michigan Rogel Cancer Center.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
This is a single-arm, single-site pilot of Radium-223 (55 kBq/kg) IV q3 weeks for up to 6 doses in combination with Atezolizumab 1200mg IV once every 3 weeks until investigator determined lack of benefit, unacceptable toxicity, or 17 doses in patients with urothelial carcinoma with bone metastases who have disease progression after platinum-containing chemotherapy.
Primary Outcome
Primary efficacy will be measured by Objective Response Rate (Complete Response + Partial Response). Complete response will be defined as the disappearance of all target lesions, determined by two separate observations conducted not less than 4 weeks apart. There can be no appearance of new lesions. Partial Response will be defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. There can be no appearance of new lesio
Interventions
- DRUG Atezolizumab
- DRUG Radium-223
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2017-11-01 |
| Est. Completion | 2018-08-02 |
| Phase | Early Phase 1 |
Why NCT03208712 stopped before completion
NCT03208712 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Atezolizumab is the first listed.
NCT03208712 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03208712 about?
NCT03208712 is a clinical study titled "Radium-223 and Atezolizumab in Patients With Urothelial Carcinoma With Bone Metastases Who Have Had Disease Progression After Platinum-Based Chemotherapy". This is a single-arm, single-site pilot of Radium-223 (55 kBq/kg) IV q3 weeks for up to 6 doses in combination with Atezolizumab 1200mg IV once every 3 weeks until investigator determined lack of benefit, unacceptable toxicity, or 17 doses in patients with urothelial carcinoma with bone metastases w...
What is the current status of trial NCT03208712?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 1 participants. The study started on 2017-11-01. Estimated completion is 2018-08-02.
What interventions are being tested in trial NCT03208712?
The interventions under investigation include: Atezolizumab (DRUG), Radium-223 (DRUG).
Who is sponsoring clinical trial NCT03208712?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03208712's enrollment target sits among peer trials
1 1985th of 2000 the lowest of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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