Status:
COMPLETED
A Phase I Trial to Assess the Effects of Food and Formulation on PK of KPT-330 in Patients With Sarcoma
Lead Sponsor:
Karyopharm Therapeutics Inc
Conditions:
Sarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 30 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 21 2016
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT01896505
Start Date
July 30 2013
End Date
October 21 2016
Last Update
January 8 2024
Active Locations (2)
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1
Memorial Sloan Kettering Cancer Centre
New York, New York, United States, 10065
2
Princess Margaret Hospital
Toronto, Ontario, Canada, M5T 2M9