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NCT01607892 · ClinicalTrials.gov registry record · Phase 1
Safety Study of the Selective Inhibitor of Nuclear Export (SINE) KPT-330 in Patients With Advanced Hematological Cancer
A Phase 1 study, sponsored by Karyopharm Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 286
- Enrollment target
NCT01607892: Completed Phase 1 study, sponsored by Karyopharm Therapeutics.
NCT01607892 is a Phase 1 study that has completed, run by Karyopharm Therapeutics. The registered enrollment target is 286 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (377% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01607892, a Phase 1 study, has completed, sponsored by Karyopharm Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 286 participants
- Enrollment target
Study Summary
The purpose of this research study is to find out more information relating to the highest dose of KCP-330 that can be given safely and side effects it may cause, to examine how the body affects KCP-330 concentrations in the blood (pharmacokinetics or PK), to examine the effects of KCP-330 on the body (pharmacodynamics or PDn) and to obtain information on its effectiveness in treating cancer.
Primary Outcome
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product during the course of a study and which does not necessarily have to have a causal relationship with this treatment. An Serious adverse event (SAE) was an AE resulting in any of the following outcomes: death; life-threatening event; required or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. TEAEs are any
Interventions
- DRUG KPT-330
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 286 participants |
| Start Date | 2012-07-23 |
| Est. Completion | 2015-10-13 |
| Phase | Phase 1 |
What the finished NCT01607892 record still lists
NCT01607892 is an interventional study that assigns participants to a tested intervention. The registered 286 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (377% higher).
The record links to 0 conditions, and to 1 intervention - of which KPT-330 is the first listed.
NCT01607892 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01607892 about?
NCT01607892 is a clinical study titled "Safety Study of the Selective Inhibitor of Nuclear Export (SINE) KPT-330 in Patients With Advanced Hematological Cancer". The purpose of this research study is to find out more information relating to the highest dose of KCP-330 that can be given safely and side effects it may cause, to examine how the body affects KCP-330 concentrations in the blood (pharmacokinetics or PK), to examine the effects of KCP-330 on the bo...
What is the current status of trial NCT01607892?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 286 participants. The study started on 2012-07-23. Estimated completion is 2015-10-13.
What interventions are being tested in trial NCT01607892?
The interventions under investigation include: KPT-330 (DRUG).
Who is sponsoring clinical trial NCT01607892?
This trial is sponsored by Karyopharm Therapeutics, which has 25 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01607892's enrollment target sits among peer trials
286 139th of 2000 higher than 1,862 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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