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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 is a Phase 1 study that was terminated before completion, run by Sumitomo Pharma America. The registered enrollment target is 20 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03593915
The ClinicalTrials.gov registry entry for NCT03593915 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sumitomo Pharma America, which has 168 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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