Bioavailability and Food Effect Study of TKI258 (CSF Capsule vs. FMI Tablet) in Adult Patients With Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Neoplasm, Cancer, Tumors

In brief

This study will evaluate the relative bioavailability of 2 oral formulations of TKI258, and the effect of food on the bioavailability of TKI258, in adult patients with advanced solid tumor.

Key facts

Study ID

NCT01155713

Run by

Novartis Pharmaceuticals

People needed

63

Starts

2010-07-01

Expected to finish

2013-11-01

Last updated by the study team

2020-12-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with an advanced solid tumor which has progressed despite standard therapy, or for which no standard therapy exists
• World Health Organization (WHO) performance status ≤ 2
• Patient must meet protocol-specified laboratory values

You may not qualify if…

• Patients with brain cancer
• Patients who have concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study
• Patients who have not recovered from previous anti-cancer therapies
• Female patients who are pregnant, breast feeding, or not willing to use an effective method of birth control
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Scottsdale Healthcare/TGen Clinical Research Service TGen Clinical Research Service — Scottsdale, Arizona, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Sarah Cannon Research Institute Sarah Cannon Research Instit — Nashville, Tennessee, United States
• University of Utah / Huntsman Cancer Institute — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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