OHSU

IRB #

IRB00009264

Title

CSTI571X2103: A dose-finding phase Ib multicenter study of imatinib in combination with the oral phosphatidyl-inositol 3-kinase (PI3K) inhibitor BYL719 in patients with gastrointestinal stromal tumor (GIST) who failed prior therapy with imatinib and sunitinib.

Principal Investigator

Michael Heinrich

Study Purpose

The purpose of this study is to find out if the addition of BYL719 (the study drug), at different dose levels, to imatinib is safe and has beneficial effects in people who failed the GIST therapy with imatinib and sunitinib.

Medical Condition(s)

Unresectable or metastatic GIST

Eligibility Criteria

* Subjects must have histologically confirmed unresectable or metastatic gastroIntestinal stormal tumor (GIST)
* Subjects must be 18 or older
* Subjects must have failed prior therapy with imatinib followed by sunitinib

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

Until disease progression or unacceptable side effect

Minors Included

No

Contact

Tracy Walker, RN (503) 346-1183 or trials@ohsu.edu

Sponsor

Novartis

Recruitment End

12/01/2014

Compensation Provided

Yes

Compensation

You may be reimbursed up to $57.00 per study visit for meals and parking fees. In addition, you may be able to receive up to $250.00 for hotel stays per study visit where applicable.


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