Carcinoma, Islet Cell Clinical Trial
Official title:
A Phase III Randomized, Double-Blind Study Of Sunitinib (SU011248, SUTENT) Versus Placebo In Patients With Progressive Advanced/Metastatic Well-Differentiated Pancreatic Islet Cell Tumors
This study randomized patients with advanced pancreatic islet cell tumors to receive either
sunitinib or placebo. Patients who were randomized to sunitinib received 37.5 mg of
sunitinib daily, those randomized to placebo received a tablet that looked similar but had
no active drug. Neither the patient or the doctor knew whether the patient was receiving
sunitinib or placebo. Patients were followed to determine the status and size of their
tumors, survival, quality of life and safety of the drug.
The study was designed to detect a 50% improvement in median PFS[Progression Free Survival]
with 90% power and was to enroll 340 subjects. An interim analysis was planned when 130
events had occurred, and the final analysis was to be conducted when 260 events had
occurred.
Study A6181111 was stopped early during the enrollment period because of a clear and
clinically meaningful improvement in efficacy for the sunitinib treatment arm as recommended
by the DMC [Data Monitoring Committee]. The actual number of subjects enrolled was 171 and
the actual number of PFS events recorded was 81 PFS events. The decision to terminate the
study was not based on safety concerns related to sunitinib administration.
The study was terminated on 11 March 2009 because the independent Data Monitoring Committee determined that the study had met its primary endpoint in demonstrating improvement in progression-free survival. The decision to terminate the trial was not based on safety concerns related to sunitinib administration. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment