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NCT02530476 · ClinicalTrials.gov registry record · Phase 1
Phase I/II, Study of Selective Inhibitor of Nuclear Export (SINE) Selinexor (KPT-330) + Sorafenib in Acute Myeloid Leukemia
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT02530476: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT02530476 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02530476, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
There are 2 parts to this study: Part 1 (dose escalation) and Part 2 (dose expansion). The goal of Part 1 of this clinical research study is to find the highest tolerated dose of the combination of selinexor (KPT-330) and sorafenib (Nexavar) that can be given to patients with FLT3-ITD and -D835 mutated acute myeloid leukemia (AML) or FLT3-mutated high-risk myelodysplastic syndrome (MDS). The goal of Part 2 of this study is to learn if the dose found in Part 1 can help to control the disease. The safety of the drug combination will also be studied in both parts of this study. This is an investigational study. Sorafenib is FDA approved and commercially available to treat hepatocellular cancer. Selinexor is not FDA approved or commercially available. It is currently being used for research purposes only. The combination of selinexor and sorafenib to treat FLT3-mutated AML and high-risk MDS is investigational. The study doctor can explain how the study drugs are designed to work. Up to 52 participants will take part in this study. All will be enrolled at MD Anderson.
Primary Outcome
MTD defined as the highest dose level with \</= 1 out of 6 patients experience a dose limiting toxicity (DLT) during the first 28 days of treatment.
Interventions
- DRUG Selinexor
- DRUG Sorafenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2015-12-08 |
| Est. Completion | 2019-04-08 |
| Phase | Phase 1 |
What the finished NCT02530476 record still lists
NCT02530476 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 2 interventions - of which Selinexor is the first listed.
NCT02530476 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02530476 about?
NCT02530476 is a clinical study titled "Phase I/II, Study of Selective Inhibitor of Nuclear Export (SINE) Selinexor (KPT-330) + Sorafenib in Acute Myeloid Leukemia". There are 2 parts to this study: Part 1 (dose escalation) and Part 2 (dose expansion). The goal of Part 1 of this clinical research study is to find the highest tolerated dose of the combination of selinexor (KPT-330) and sorafenib (Nexavar) that can be given to patients with FLT3-ITD and -D835 mut...
What is the current status of trial NCT02530476?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2015-12-08. Estimated completion is 2019-04-08.
What interventions are being tested in trial NCT02530476?
The interventions under investigation include: Selinexor (DRUG), Sorafenib (DRUG).
Who is sponsoring clinical trial NCT02530476?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02530476's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 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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