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NCT04089553 · ClinicalTrials.gov registry record · Phase 2
An Open-label, Phase II Study of AZD4635 in Patients With Prostate Cancer
A Phase 2 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 2
- Development phase
- 59
- Enrollment target
NCT04089553: Completed Phase 2 study, sponsored by AstraZeneca.
NCT04089553 is a Phase 2 study that has completed, run by AstraZeneca. The registered enrollment target is 59 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04089553, a Phase 2 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 59 participants
- Enrollment target
Study Summary
This is an open-label Phase II modular study in participants with prostate cancer which will assess safety, efficacy, and tolerability of AZD4635 in combination with other therapeutic agents in different treatment arms (referred to as modules). Combinations to be studied include: 1) Module 1: AZD4635 plus durvalumab; 2) Module 2: AZD4635 plus oleclumab.
Primary Outcome
The confirmed objective response is defined as confirmed complete response (CR) or confirmed partial response (PR) based on RECIST v1.1 guidelines, assessed by computed tomography (CT) scan/ magnetic resonance imaging (MRI) scan/ positron emission tomography (PET) scan and bone scan. The CR is defined as disappearance of all target and non-target lesions and no new lesions. The PR is defined as \>= 30% decrease in the sum of the diameters of target lesions compared to baseline and no new non-tar
Interventions
- DRUG Durvalumab
- DRUG Oleclumab
- DRUG AZD4635
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2019-08-29 |
| Est. Completion | 2023-04-11 |
| Phase | Phase 2 |
What the finished NCT04089553 record still lists
NCT04089553 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower).
The record links to 0 conditions, and to 3 interventions - of which Durvalumab is the first listed.
NCT04089553 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04089553 about?
NCT04089553 is a clinical study titled "An Open-label, Phase II Study of AZD4635 in Patients With Prostate Cancer". This is an open-label Phase II modular study in participants with prostate cancer which will assess safety, efficacy, and tolerability of AZD4635 in combination with other therapeutic agents in different treatment arms (referred to as modules). Combinations to be studied include: 1) Module 1: AZD46...
What is the current status of trial NCT04089553?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 59 participants. The study started on 2019-08-29. Estimated completion is 2023-04-11.
What interventions are being tested in trial NCT04089553?
The interventions under investigation include: Durvalumab (DRUG), Oleclumab (DRUG), AZD4635 (DRUG).
Who is sponsoring clinical trial NCT04089553?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04089553's enrollment target sits among peer trials
59 1133rd of 2000 higher than 866 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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