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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 is a Phase 1 study that has completed, run by Karyopharm Therapeutics. The registered enrollment target is 54 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01896505
The ClinicalTrials.gov registry entry for NCT01896505 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Karyopharm Therapeutics, which has 25 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which KCP-330 is the first listed.
NCT01896505 reports 0 study locations.
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.
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