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NCT03179943 · ClinicalTrials.gov registry record · Phase 2
Atezolizumab + Guadecitabine in Patients With Checkpoint Inhibitor Refractory or Resistant Urothelial Carcinoma
A Phase 2 study of Urothelial Carcinoma, sponsored by Fox Chase Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
- 3
- Study locations
NCT03179943: Active Phase 2 study of Urothelial Carcinoma, sponsored by Fox Chase Cancer Center.
NCT03179943 is a Phase 2 study of Urothelial Carcinoma that is active but no longer recruiting, run by Fox Chase Cancer Center. The registered enrollment target is 21 participants, below the 239-participant average among 85 other Urothelial Carcinoma trials with a reported enrollment target (91% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03179943, a Phase 2 study of Urothelial Carcinoma, is active but no longer recruiting, sponsored by Fox Chase Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
- 3
- Study locations
Study Summary
This is a single arm Phase II study with a safety run-in to identify the recommended phase II dose of the combination therapy of atezolizumab and guadecitabine. Patients with recurrent/advanced urothelial carcinoma (stage IV) who had previously progressed on check-point inhibitor therapy with PD-1 or PD-L1 targeting agents are eligible for this study. After a dose that is safe and tolerable has been established, a dose expansion phase (Phase II) will begin. This study will enroll a total of 4 to 53 patients depending upon the number of patients treated in the safety run-in phase and the number of subjects replaced during the phase II portion.
Primary Outcome
Dose de-escalation study based on standard 3+3 design will be conducted to test two dose levels of guadecitabine: 45mg/m2 and 36mg/m2 to determine MTD
Conditions Studied
Interventions
- DRUG Atezolizumab
- DRUG Guadecitabine
Study Locations (3)
California
- USC Norris Hospital and Clinics - Los Angeles
Maryland
- Johns Hopkins University School of Medicine - Baltimore
Pennsylvania
- Fox Chase Cancer Center - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2017-11-27 |
| Est. Completion | 2022-07 |
| Phase | Phase 2 |
What the registry record for NCT03179943 still lists
NCT03179943 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 239-participant average among 85 other Urothelial Carcinoma trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Urothelial Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Atezolizumab is the first listed.
NCT03179943 reports a single indexed study location in California, Maryland, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03179943 about?
NCT03179943 is a clinical study titled "Atezolizumab + Guadecitabine in Patients With Checkpoint Inhibitor Refractory or Resistant Urothelial Carcinoma". This is a single arm Phase II study with a safety run-in to identify the recommended phase II dose of the combination therapy of atezolizumab and guadecitabine. Patients with recurrent/advanced urothelial carcinoma (stage IV) who had previously progressed on check-point inhibitor therapy with PD-1 o...
What is the current status of trial NCT03179943?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2017-11-27. Estimated completion is 2022-07.
What conditions does trial NCT03179943 study?
This clinical trial studies the following conditions: Urothelial Carcinoma.
What interventions are being tested in trial NCT03179943?
The interventions under investigation include: Atezolizumab (DRUG), Guadecitabine (DRUG).
Who is sponsoring clinical trial NCT03179943?
This trial is sponsored by Fox Chase Cancer Center, which has 183 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03179943 being conducted?
This trial has 3 study locations across California, Maryland, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03179943's enrollment target sits among peer trials
21 71st of 85 higher than 15 of 85 other Urothelial Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Urothelial Carcinoma 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.
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