A Phase I Trial to Assess the Effects of Food and Formulation on PK of KPT-330 in Patients With Sarcoma
Completed · Phase 1
Conditions studied: Sarcoma
In brief
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.
Key facts
- Study ID
- NCT01896505
- Run by
- Karyopharm Therapeutics Inc
- People needed
- 54
- Starts
- 2013-07-30
- Expected to finish
- 2016-10-21
- Last updated by the study team
- 2024-01-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients must have histologically confirmed soft tissue or bone/cartilage sarcoma. Patients with sarcoma of small round blue cell tumor types are allowed. Gastrointestinal stromal tumors (GIST) are excluded.
- Patients must have received at least one prior anticancer regimen for metastatic disease unless there is no other therapy available and evidence of progressive disease on study entry. Patients with stable disease will be included if there has been failure to respond to another drug(s) within the previous 3 months
You may not qualify if…
- Patients with known liver metastases
- Radiation, chemotherapy, immunotherapy, any other systemic anticancer therapy or participation in an investigational anti-cancer study ≤ 3 weeks prior to initiation of therapy
- Patients with known brain metastasis
- Patients with any gastrointestinal dysfunctions that could interfere with the interpretation of the food effect data
- Patients with known intolerance to low or high fat meals
- In the opinion of the investigator, patients who are significantly below their ideal body weight
Where it is running
- Memorial Sloan Kettering Cancer Centre — New York, New York, United States
- Princess Margaret Hospital — Toronto, Ontario, Canada
Full record on ClinicalTrials.gov
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