Gastrointestinal Stromal Tumors (GIST) Clinical Trial
Official title:
An Open-label, Multi-center Study to Evaluate the Efficacy and Safety of Nilotinib in Adult Patients With Gastrointestinal Stromal Tumors Resistant or Intolerant to Imatinib and or to 2nd Line Tyrosine Kinas (TK) Inhibitor
The mainstay of therapy for GISTs is surgical resection, however, recurrence is almost
inevitable in high-risk tumors and secondary surgery or other salvage therapy has yielded
poor outcome. The median survival for patients with unresectable or metastatic GIST is
approximately 20 months, and for patients with local recurrence it is 9 to 12 months.
Responses to chemotherapy have been at best 5%. The introduction of imatinib has
dramatically changed the prognosis of these patients yielding response rates between 41% and
71% and an overall clinical benefit (tumor responses plus stable disease) ranging between
73% and 90%.
However, resistance to imatinib may develop and represents a further clinical challenge.
Sunitinib has recently been approved by the FDA for patients whose disease has progressed or
who are intolerant to imatinib therapy. Patients with tumor progressing on sunitinib or
another 2nd line agent have limited therapeutic alternatives. Reinstitution of imatinib, if
possible, is considered an acceptable option for these patients because it may slow the rate
of disease progression even in the setting of prior imatinib failure; however a more optimal
3rd line treatment is needed. AMN107 is a novel aminopyrimidine, available as an oral
formulation that is ATP -competitive inhibitor of BCR-ABL,more potent than Imatinib. It
inhibits proliferation and autophosphorylation of 32 out of 33 BCR-ABL point mutations. In
addition AMN107 also inhibits PDGFRα,PDGFRβ, and KIT. Preliminary data from an ongoing Phase
I study in imatinib-resistant GIST patients (CAMN107A2103) indicate that AMN107 alone (400
mg BID) and in combination with imatinib (imatinib 400 mg BID plus AMN107 200 mg QD and 400
mg QD) is well tolerated in this pre-treated patients.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT05160168 -
A Study of THE-630 in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
|
Phase 1/Phase 2 | |
| Completed |
NCT02508532 -
(NAVIGATOR) Study of BLU-285 in Patients With Gastrointestinal Stromal Tumors (GIST) and Other Relapsed and Refractory Solid Tumors
|
Phase 1 |