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NCT03298984 · ClinicalTrials.gov registry record · Phase 1
Ph I Study of Alvocidib and Cytarabine/Daunorubicin (7+3) in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML).
A Phase 1 study, sponsored by Sumitomo Pharma America.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT03298984: Completed Phase 1 study, sponsored by Sumitomo Pharma America.
NCT03298984 is a Phase 1 study that has completed, run by Sumitomo Pharma America. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03298984, a Phase 1 study, has completed, sponsored by Sumitomo Pharma America.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
The purpose of this Phase I study is to determine the safety and tolerability including the maximum dose (MTD) and dose-limiting toxicities (DLTs) of alvocidib when administered over a range of doses on Days 1-3 followed by cytarabine/daunorubicin (7+3) on Days 5-11 in adults with newly diagnosed and previously untreated AML
Primary Outcome
Determine the safety and tolerability including the maximum tolerated dose (MTD) of alvocidib when administered over a range of doses on Days 1-3 followed by Ara-c/daunorubicin (7+3) on Days 5-11 in adults with newly diagnosed and previously untreated AML
Interventions
- DRUG Cytarabine
- DRUG Daunorubicin
- DRUG Alvocidib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2017-09-25 |
| Est. Completion | 2020-03-20 |
| Phase | Phase 1 |
What the finished NCT03298984 record still lists
NCT03298984 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 3 interventions - of which Cytarabine is the first listed.
NCT03298984 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03298984 about?
NCT03298984 is a clinical study titled "Ph I Study of Alvocidib and Cytarabine/Daunorubicin (7+3) in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML).". The purpose of this Phase I study is to determine the safety and tolerability including the maximum dose (MTD) and dose-limiting toxicities (DLTs) of alvocidib when administered over a range of doses on Days 1-3 followed by cytarabine/daunorubicin (7+3) on Days 5-11 in adults with newly diagnosed an...
What is the current status of trial NCT03298984?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2017-09-25. Estimated completion is 2020-03-20.
What interventions are being tested in trial NCT03298984?
The interventions under investigation include: Cytarabine (DRUG), Daunorubicin (DRUG), Alvocidib (DRUG).
Who is sponsoring clinical trial NCT03298984?
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 NCT03298984's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 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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