TRIAL DETAIL

Trial of Tasigna (Nilotinib) 400 mg Twice Daily Alone or With Gleevec (Imatinib Mesylate) 400 mg Daily for Patients With Advanced Gastrointestinal Stromal Tumor (GIST)

Drug:
Trial Name:
Trial of Tasigna (Nilotinib) 400 mg Twice Daily Alone or With Gleevec (Imatinib Mesylate) 400 mg Daily for Patients With Advanced Gastrointestinal Stromal Tumor (GIST)
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Terminated
Phase:
2
Start Date 02/01/2009
Age of Trial (yrs) 14.7
Treatment Phase:
Gleevec-resistant
Drug Category:
KIT inhibitor
Strategy:
Block KIT
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
FER-SAR-023
Sponsor:
Fox Chase Cancer Center
Patient Contact:
Holly Tuttle, RN 215 728 2451 holly.tuttle@fccc.edu
Contact email:
Contact Phone:
Randomized:
Randomized
IV or Oral:
Oral
Trial Notes:
Only prior Imatinib allowed.

Exclusion Criteria: "Patients who have received nilotinib or additional tyrosine kinase inhibitors or additional targeted therapies (except for imatinib)."

Resistance to imatinib does develop and represents a major clinical challenge. Mechanisms implicated in imatinib resistance include: target resistance due to new KIT or PDGFRA mutations or over expression of the KIT protein; target modulation due to activation of an alternate receptor tyrosine kinase protein with loss of KIT oncoprotein expression; functional resistance due to KIT or PDGFRA activation without a secondary mutation; and alterations in imatinib uptake by P-glycoprotein.

This study seeks to test nilotinib alone and nilotinib in combination with imatinib in patients that have progressed on imatinib.

Nilotinib is a new synthetic second-generation inhibitor of the BCR-ABL tyrosine kinase that competes for the ATP-bindings sites of BCR-ABL. A completed phase I trial assessed the activity of nilotinib alone and in combination with imatinib in patients that have progressed on imatinib in a population of patients with imatinib refractory and intolerant patients. There were rare responses, but stable disease was observed in grater than 50% of patients.

This study is aiming to treat patients with advanced or metastatic GIST who have disease progression on imatinib dose escalated up to 600 mg or greater. The rationale for exploring Nilotinib in this setting is to determine if it has therapeutic efficacy, with potentially less toxicity than the current standard of care for second line therapy. In addition, since it is not uncommon to see progression of some metastatic GIST lesions on imatinib, while others remain controlled, adding nilotinib may treat the progressing lesions while imatinib continues to control the areas without disease progression.

Trial Links

Trial Results

Drug Information

Trial Sites

Name
Address
City
State
Zip
Country
333 Cottman Ave
Philadelphia
PA
19111
USA
Medical Center Boulevard
Winston-Salem
NC
27157
USA
660 S. Euclid Ave
St. Louis
MO
63110
USA