Pfizer has announced a new phase I/II clinical trial will soon be opening for pediatric and young adults with GIST. This trial will be testing Sutent (sunitinib), the currently approved second-line treatment for GIST, in young patients. At the current time, the optimal dose for Sutent is not known for pediatric patients. This trial will help assess the safety and tolerability of Sutent in young patients.
Patients from age 6 to age 21 will be eligible for the trial. Patients younger than 18 years old will receive a dose based on bodyweight (15mg/m2) and patients >18 years old will receive the same dose that adults currently get, 50 mg daily. Both groups will take the drug for 4 weeks followed by a 2 week break off drug.
Due to the rarity of pediatric GIST patients, Pfizer has indicated a willingness to try to open a trial site wherever in the world that it might be needed. At the moment, it plans to open up to 50 sites in 26 countries for 30 patients.
Although data is limited, there are some reports of some patients responding to Sutent.
This trial may be of particular value to those patients who cannot access Sutent otherwise in their home countries.
For more information, check out http://www.clinicaltrials.gov/ct2/show/NCT01396148 or liferaftgroup.org for protocol and clinical trial site information.