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NCT03614728 · ClinicalTrials.gov registry record · Phase 1
Study to Investigate the Safety and Clinical Activity of GSK3326595 and Other Agents to Treat Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)
A Phase 1 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT03614728: Clinical Trial Phase 1 study, sponsored by GlaxoSmithKline.
NCT03614728 is a Phase 1 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03614728, a Phase 1 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This study will evaluate the safety, tolerability, and clinical activity of GSK3326595 in participants with relapsed and refractory MDS, chronic myelomonocytic leukemia (CMML), and AML. The study will be conducted in 2 parts: Part 1 will determine the clinical benefit rate (CBR) of GSK3326595 in monotherapy and Part 2 will be expanded to study GSK3326595 in combination with 5-Azacitidine which will be composed of a dose escalation phase followed by dose expansion cohort of GSK3326595.
Primary Outcome
CBR is defined as the percentage of participants achieving a complete remission (CR), complete marrow remission (mCR), partial remission (PR), stable disease (SD) lasting at least 8 weeks, or hematologic improvement (HI), per International Working Group (IWG) criteria, where CR=Bone marrow:\<=5 percent(%) myeloblasts with normal maturation of all cell lines; PR=Bone marrow blasts decreased by \>=50% over pre-treatment but still \>5%; mCR=Bone marrow: \<=5% myeloblasts and decrease by \>=50% over
Interventions
- DRUG 5-Azacitidine
- DRUG GSK3326595
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2018-10-16 |
| Est. Completion | 2022-01-11 |
| Phase | Phase 1 |
Why NCT03614728 stopped before completion
NCT03614728 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 2 interventions - of which 5-Azacitidine is the first listed.
NCT03614728 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03614728 about?
NCT03614728 is a clinical study titled "Study to Investigate the Safety and Clinical Activity of GSK3326595 and Other Agents to Treat Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)". This study will evaluate the safety, tolerability, and clinical activity of GSK3326595 in participants with relapsed and refractory MDS, chronic myelomonocytic leukemia (CMML), and AML. The study will be conducted in 2 parts: Part 1 will determine the clinical benefit rate (CBR) of GSK3326595 in mon...
What is the current status of trial NCT03614728?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2018-10-16. Estimated completion is 2022-01-11.
What interventions are being tested in trial NCT03614728?
The interventions under investigation include: 5-Azacitidine (DRUG), GSK3326595 (DRUG).
Who is sponsoring clinical trial NCT03614728?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03614728's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 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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