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NCT03218683 · ClinicalTrials.gov registry record · Phase 1
Study of AZD5991 Alone or in Combination With Venetoclax in Relapsed or Refractory Haematologic Malignancies.
A Phase 1 study, sponsored by AstraZeneca.
- Terminated
- Registry status
- Phase 1
- Development phase
- 70
- Enrollment target
NCT03218683: Clinical Trial Phase 1 study, sponsored by AstraZeneca.
NCT03218683 is a Phase 1 study that was terminated before completion, run by AstraZeneca. The registered enrollment target is 70 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03218683, a Phase 1 study, was terminated before completion, sponsored by AstraZeneca.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 70 participants
- Enrollment target
Study Summary
This study is a multicenter, open-label, nonrandomized, sequential group, dose-escalation study to assess safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of ascending doses of AZD5991 in subjects with relapsed or refractory hematologic malignancies Part 1 of the study is monotherapy dose escalation. Closed November 2020 Part 2 of the study is monotherapy expansion groups for relapsed/refractory chronic lymphocytic leukaemia (CLL), AML/ myelodysplastic syndromes (MDS), and multiple myeloma (MM). Closed November 2020 Part 3 is a sequential, dose-escalation study of the combination of AZD5991 and venetoclax in subjects with relapsed/refractory AML
Primary Outcome
Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters
Interventions
- DRUG AZD5991
- DRUG AZD5991 + Venetoclax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2017-08-02 |
| Est. Completion | 2021-10-08 |
| Phase | Phase 1 |
Why NCT03218683 stopped before completion
NCT03218683 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% higher).
The record links to 0 conditions, and to 2 interventions - of which AZD5991 is the first listed.
NCT03218683 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03218683 about?
NCT03218683 is a clinical study titled "Study of AZD5991 Alone or in Combination With Venetoclax in Relapsed or Refractory Haematologic Malignancies.". This study is a multicenter, open-label, nonrandomized, sequential group, dose-escalation study to assess safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of ascending doses of AZD5991 in subjects with relapsed or refractory hematologic malignancies Part 1 of the study is m...
What is the current status of trial NCT03218683?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2017-08-02. Estimated completion is 2021-10-08.
What interventions are being tested in trial NCT03218683?
The interventions under investigation include: AZD5991 (DRUG), AZD5991 + Venetoclax (DRUG).
Who is sponsoring clinical trial NCT03218683?
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 NCT03218683's enrollment target sits among peer trials
70 749th of 2000 higher than 1,227 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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