Conditions: Carcinoma, Islet Cell Carcinoma, Pancreas
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 171
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: sunitinib malate intervention 2: Placebo
Intervention descriptions: intervention 1: * sunitinib malate oral starting dose 37.5 mg daily (continuous dosing).
* Dose may be decreased to 25 mg daily in case of adverse events.
* It may be increased to 50 mg daily if no response is seen after 8 weeks on treatment.
* Dosing to continue until unacceptable toxicity, progression of disease, death, or study termination. intervention 2: Placebo to match sunitinib taken daily (oral) on the same schedule as active agent below.

Protocol document: