Trials / Completed
CompletedNCT01896505
A Phase I Trial to Assess the Effects of Food and Formulation on PK of KPT-330 in Patients With Sarcoma
An Open-Label Phase IB Trial To Evaluate the Effects of Food and Formulation on Pharmacokinetics of the Oral Selective Inhibitor of Nuclear Export/SINE Compound KPT-330 in Patients With Soft-Tissue or Bone Sarcoma
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 54 (actual)
- Sponsor
- Karyopharm Therapeutics Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | KCP-330 |
Timeline
- Start date
- 2013-07-30
- Primary completion
- 2016-10-21
- Completion
- 2016-10-21
- First posted
- 2013-07-11
- Last updated
- 2024-01-08
- Results posted
- 2024-01-08
Locations
2 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT01896505. Inclusion in this directory is not an endorsement.