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Nilotinib (Tasigna, previously called AMN107)
Nilotinib is a tyrosine kinase inhibitor (like imatinib/Gleevec) designed to bind more tightly than Gleevec to the Bcr-Abl abnormal fusion protein responsible for chronic myeloid leukemia. Phase 1 trials in CML patients show greater effectiveness for nilotinib compared to imatinib (Kantarjian et al, 2006). Nilotinib also binds the KIT and PDGFRA proteins that are relevant to GIST, as shown by cell studies.
A patient who does not qualify for any of the trials described below may consider having his/her oncologist prescribe nilotinib off-label, though insurance may not cover off-label use. Alternatively, the patient may apply to obtain nilotinib through the Novartis Patient Assistance Program. The Novartis Oncology Reimbursement Hotline (1-800-282-7630) will be able to provide assistance with the reimbursement process for Novartis products.
July 2008: Currently recruiting, a new trial of nilotinib has opened for GIST patients who have experienced progression on both imatinib and sunitinib. LINK HERE for the description. This is a new trial being done only at Fox Chase. Phone 888 FOX CHASE to inquire about the trial. Entry criteria are similar
to the previous study, but patients can have used other tyrosine kinase inhibitors besides Gleevec and Sutent. Patients must have had progression on both Gleevec and Sutent. This is not a placebo trial; all patients will receive nilotinib.
September 2008 trial of nilotinib as FIRST LINE THERAPY: This new Phase II trial will evaluate nilotinib in GIST patients who have not had prior drug treatment. Phase LINK HERE for NCT00756509.
September 2008 listed trial of nilotinib not yet recruiting: This Phase III trial will randomize patients who have had RECIST progression on 400 mg of imatinib (but not doses higher than 400 mg) to an arm for 800 mg imatinib versus an arm for 800 mg nilotinib. LINK HERE for the description.
The first Phase 1 trial of nilotinib/AMN107 in GIST patients (together with imatinib) was begun in August 2005 and has now stopped recruiting patients. There is little information yet to indicate whether nilotinib combined with imatinib will be more effective against GIST than imatinib (Gleevec) alone. The main purpose of Phase 1 trials is to determine whether a drug is safe and to determine a tolerable dose. The fact that nilotinib has already been tried in trials with CML patients does increase the likelihood that it will be found safe. You can read two abstracts about this trial:
- an abstract of a paper presented at ASCO 2006 entitled "A phase I study of AMN107 alone and in combination with imatinib in patients (pts) with imatinib-resistant gastrointestinal stromal tumors (GIST)." This was a preliminary report.
- an abstract of a paper presented at ASCO 2007 entitled "A phase I study of nilotinib alone and in combination with imatinib (IM) in patients (pts) with imatinib-resistant gastrointestinal stromal tumors (GIST) - Study update." This update indicated that 68% of patients achieved stable disease lasting from 6 weeks to over 6 months, including 2 paients with wild-type GIST (no detected mutations).
A second trial of nilotinib against imatinib-resistant GIST which began in April 2007, has also stopped recruiting patients. For trial details and a list of all the sites see NCT00471328.
For information on this drug from manufacturer Novartis, link here.
Link to AMN107 information on the Novartis website
http://www.novartisoncology.com/page/amn107.jsp
Link for AMN107 medical papers in PubMed
