Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03593915 · ClinicalTrials.gov registry record · Phase 1
A Phase 1b/2 Study of Alvocidib Plus Decitabine or Azacitidine in Patients With MDS
A Phase 1 study, sponsored by Sumitomo Pharma America.
- Terminated
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT03593915: Clinical Trial Phase 1 study, sponsored by Sumitomo Pharma America.
NCT03593915 is a Phase 1 study that was terminated before completion, run by Sumitomo Pharma America. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03593915, a Phase 1 study, was terminated before completion, sponsored by Sumitomo Pharma America.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
Alvocidib, a cyclin-dependent kinase 9 (CDK 9) inhibitor, in time-sequential therapy demonstrated significant clinical activity in secondary AML patients with prior MDS. Patients with IPSS-R intermediate and above MDS have an increased risk of developing AML and may be treated with the same chemotherapy regimens used in patients with AML. Eight Phase I or II clinical trials have been completed in patients with AML, totaling more than 400 patients with both relapsed/refractory or newly diagnosed AML. Preclinical studies have demonstrated that decitabine exposure increased the expression of NOXA, which is a specific antagonist of the survival factor MCL 1. Pharmacologic downregulation of MCL-1 via CDK 9 inhibition, as well as upregulation of the MCL-1 antagonist, NOXA, following decitabine exposure may result in enhanced antileukemic activity in MCL-1-dependent malignancies.
Primary Outcome
Assessment of safety of alvocidib administered in combination with either decitabine (DEC) or azacitidine (AZA) by reporting of adverse events and serious adverse events
Interventions
- COMBINATION_PRODUCT Alvocidib Plus Decitabine (during dose escalation only) or Azacitidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2018-08-29 |
| Est. Completion | 2021-08-16 |
| Phase | Phase 1 |
Why NCT03593915 stopped before completion
NCT03593915 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 1 intervention - of which Alvocidib Plus Decitabine (during dose escalation only) or Azacitidine is the first listed.
NCT03593915 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03593915 about?
NCT03593915 is a clinical study titled "A Phase 1b/2 Study of Alvocidib Plus Decitabine or Azacitidine in Patients With MDS". Alvocidib, a cyclin-dependent kinase 9 (CDK 9) inhibitor, in time-sequential therapy demonstrated significant clinical activity in secondary AML patients with prior MDS. Patients with IPSS-R intermediate and above MDS have an increased risk of developing AML and may be treated with the same chemothe...
What is the current status of trial NCT03593915?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2018-08-29. Estimated completion is 2021-08-16.
What interventions are being tested in trial NCT03593915?
The interventions under investigation include: Alvocidib Plus Decitabine (during dose escalation only) or Azacitidine (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT03593915?
This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03593915's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00573339 · 20 participants
Cardiac Magnetic Resonance Imaging (MRI) Normal Reference Control Group Testing
- NCT00692939 · 20 participants · Phase 1
Autologous Stem Cell Transplantation for Crohn's Disease
- NCT00967785 · 20 participants · Phase 1
A Phase I Study of Mozobil in the Treatment of Patients With WHIMS
- NCT01406691 · 20 participants · Phase 4
Light Flashes to Treat Delayed Sleep Phase Disorder (DSPD)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI