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NCT01896505 · ClinicalTrials.gov registry record · Phase 1
A Phase I Trial to Assess the Effects of Food and Formulation on PK of KPT-330 in Patients With Sarcoma
A Phase 1 study, sponsored by Karyopharm Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
NCT01896505: Completed Phase 1 study, sponsored by Karyopharm Therapeutics.
NCT01896505 is a Phase 1 study that has completed, run by Karyopharm Therapeutics. The registered enrollment target is 54 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01896505, a Phase 1 study, has completed, sponsored by Karyopharm Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
Study Summary
The purpose of this research study is to find out more information such as: to determine the effects of high and low fat foods on the pharmacokinetics (PK) of oral KPT-330 tablets and to compare PK of capsules and tablets in Arms 1 and 2; to evaluate tumor response in sarcoma participants in Arm 3; to compare the PK of 60 milligrams (mg) of the new, 2nd generation tablet formulation and 60 mg of the selinexor suspension formula to the current, 1st generation tablets.
Primary Outcome
AUC0-t was defined as area under the concentration-time curve from time zero to the last non-zero concentration.
Interventions
- DRUG KCP-330
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2013-07-30 |
| Est. Completion | 2016-10-21 |
| Phase | Phase 1 |
What the finished NCT01896505 record still lists
NCT01896505 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 1 intervention - of which KCP-330 is the first listed.
NCT01896505 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01896505 about?
NCT01896505 is a clinical study titled "A Phase I Trial to Assess the Effects of Food and Formulation on PK of KPT-330 in Patients With Sarcoma". The purpose of this research study is to find out more information such as: to determine the effects of high and low fat foods on the pharmacokinetics (PK) of oral KPT-330 tablets and to compare PK of capsules and tablets in Arms 1 and 2; to evaluate tumor response in sarcoma participants in Arm 3; ...
What is the current status of trial NCT01896505?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2013-07-30. Estimated completion is 2016-10-21.
What interventions are being tested in trial NCT01896505?
The interventions under investigation include: KCP-330 (DRUG).
Who is sponsoring clinical trial NCT01896505?
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 NCT01896505's enrollment target sits among peer trials
54 931st of 2000 higher than 1,053 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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