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NCT02403310 · ClinicalTrials.gov registry record · Phase 1
A Study of Selinexor in Combination With Daunorubicin and Cytarabine for Untreated AML
A Phase 1 study of Acute Myeloid Leukemia and Leukemia, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT02403310: Completed Phase 1 study of Acute Myeloid Leukemia and Leukemia, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT02403310 is a Phase 1 study of Acute Myeloid Leukemia and Leukemia that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 21 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02403310, a Phase 1 study of Acute Myeloid Leukemia and Leukemia, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
The main purpose of this study is to determine the safety of combining selinexor with daunorubicin and cytarabine. The maximal tolerated dose (MTD) of selinexor with daunorubicin and cytarabine will also be established.
Primary Outcome
MTD / Recommended Phase II Dose (RP2D) of selinexor with daunorubicin and cytarabine. Dose Limiting Toxicity (DLT): Non-hematologic - Any grade 3-4 drug-related non-hematologic toxicity, with the following exceptions: Nausea/vomiting or diarrhea adequately controlled with antiemetics/antidiarrheals; Infection or febrile neutropenia adequately controlled with antibiotics; Liver function abnormalities (without clinical symptoms) that recover to baseline or grade 0-1 within 7 days; Grade 3-4 electr
Conditions Studied
Interventions
- DRUG Selinexor
- DRUG Cytarabine
- DRUG Daunorubicin
Study Locations (1)
Florida
- H. Lee Moffitt Cancer Center and Research Institute - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2015-06-18 |
| Est. Completion | 2021-02-01 |
| Phase | Phase 1 |
What the finished NCT02403310 record still lists
NCT02403310 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (82% lower).
The record links to 3 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Selinexor is the first listed.
NCT02403310 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT02403310 about?
NCT02403310 is a clinical study titled "A Study of Selinexor in Combination With Daunorubicin and Cytarabine for Untreated AML". The main purpose of this study is to determine the safety of combining selinexor with daunorubicin and cytarabine. The maximal tolerated dose (MTD) of selinexor with daunorubicin and cytarabine will also be established.
What is the current status of trial NCT02403310?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2015-06-18. Estimated completion is 2021-02-01.
What conditions does trial NCT02403310 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Leukemia, AML.
What interventions are being tested in trial NCT02403310?
The interventions under investigation include: Selinexor (DRUG), Cytarabine (DRUG), Daunorubicin (DRUG).
Who is sponsoring clinical trial NCT02403310?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02403310 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT02403310's enrollment target sits among peer trials
21 244th of 306 higher than 62 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia 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.
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