An open-label, multi-center study to evaluate the efficacy of nilotinib in adult patients with gastrointestinal stromal tumors resistant to imatinib and sunitinib

ovartis Pharma GmbH0 sitesMarch 15, 2010

Overview

No summary available.

Registry

who.int

Start Date

March 15, 2010

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

ovartis Pharma GmbH

•Age \= 18 years
•Histologically confirmed diagnosis of GIST that is unresectable and/or metastatic and therefore not amenable to surgery or combined modality with curative intent prior to or at Visit 1\.
•Radiologically confirmed disease progression during imatinib therapy at a dose of at least 400 mg daily and/or radiologically confirmed disease progression during sunitinib therapy OR documented intolerance (defined above in population) to imatinib and/or sunitinib. (Patients with prior additional investigational treatment of GIST prior to study entry can be included).
•At least one measurable site of disease on CT/MRI as defined by RECIST criteria (see Protocol Post Text Supplement 3 for details). The scans should not be older than approximately 2\-4 weeks. New scans are only required as baseline scans if they are older than approximately 2\-4 weeks.
•WHO Performance Status of 0, 1 or 2\.
•Patients should have the following laboratory values (\= LLN (lower limit of normal) or corrected to within normal limits with supplements prior to the first dose of study medication):
•\- Potassium \= LLN,
•\- Magnesium \= LLN,
•\- Phosphorus \= LLN,
•Total calcium (corrected for serum albumin) \= LLN.

•Prior treatment with nilotinib.
•Treatment with any cytotoxic and/or investigational cytotoxic drug \= 4 weeks (6 weeks for nitrosurea or mitomycin C) prior to Visit 1\.
•Prior or concomitant malignancies requiring active treatment other than GIST with the exception of previous or concomitant basal cell skin cancer, previous cervical carcinoma in situ.
•Impaired cardiac function at visit 1 any one of the following:
•\- LVEF \< 45% or below the institutional LLN range (whichever is higher) as determined by echocardiogram or MUGA scans at Visit 1\.
•\- Complete left bundle branch block.
•\- Use of a ventricular paced cardiac pacemaker.
•\- Congenital long QT syndrome or family history of long QT syndrome.
•\- History of or presence of significant ventricular or atrial tachyarrhythmias.
•\- Clinically significant resting bradycardia (\< 50 beats per minute).