Nilotinib in Advanced Gastrointestinal Stromal Tumors (GIST) (07060)

Nilotinib in Advanced Gastrointestinal Stromal Tumors (GIST) (07060)

Gastrointestinal Stromal Tumor

Terminated

2

Start Date 07/01/2008

Age of Trial (yrs) 16.4

Gleevec-resistant

KIT/PDGFRA inhibitor

Block KIT

Specifically GIST and only GIST

IRB07060 IRB Number: 07060 RRC Number: 11707 CAMN107DUS05T

Fox Chase Cancer Center

See site contact info below

Oral

This study has been terminated.
( Stopped early for futility, unable to meet accrual goals )

Patients must have confirmed GIST and must have failed both imatinib and sunitinib. Patients must have a measureable tumor. Patients may also have had other TKI therapy besides imatinib and sunitinib. There is a two week washout for prior investigational drugs.

"Patients must have received and progressed on imatinib and sunitinib.
Except for nilotinib, patients may have received additional tyrosine kinase inhibitors or additional targeted therapies."

"Because no dosing or adverse event data are currently available on the use of nilotinib in patients < 18 years of age, children are excluded from this study."

ECOG status 0-2 is accepted.

There are a number of cardio function criteria that should be looked at closely.

There is no control arm. All patients will receive nilotinib.

Objectives are as follows:

"1.1 Primary Objectives: To determine the progression free survival rate at
6 months in patients with advanced GIST previously treated with imatinib and sunitinb receiving nilotinib

1.2 Secondary Objectives: To determine the response rate of nilotinib in patients with advanced GIST previously treated with imatinib and sunitinib.
Response will primarily be determined by RECIST criteria, but will also be compared to response as defined by CHOI and PET criteria

1.3 Exploratory Objectives: To explore if there is a correlation of response to the GIST primary mutation status"

Monica asked that patients interested in this trial not call her directly.
They should call 1-888 "Fox Chase" (369-2427). They will be directed from there.