Please select the arm or intervention descriptions that belong to the clinical trial below.
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
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.


Options:
A: Arm Label: Arm I (octreotide acetate and bevacizumab); Type: EXPERIMENTAL; Interventions: Biological: Bevacizumab, Other: Laboratory Biomarker Analysis, Drug: Octreotide Acetate | Arm Label: Arm II (octreotide acetate and recombinant interferon alfa-2b); Type: EXPERIMENTAL; Interventions: Other: Laboratory Biomarker Analysis, Drug: Octreotide Acetate, Biological: Recombinant Interferon Alfa-2b | Intervention Type: BIOLOGICAL; Name: Bevacizumab; Assigned to Arm(s): Arm I (octreotide acetate and bevacizumab) | Intervention Type: OTHER; Name: Laboratory Biomarker Analysis; Assigned to Arm(s): Arm I (octreotide acetate and bevacizumab), Arm II (octreotide acetate and recombinant interferon alfa-2b) | Intervention Type: DRUG; Name: Octreotide Acetate; Assigned to Arm(s): Arm I (octreotide acetate and bevacizumab), Arm II (octreotide acetate and recombinant interferon alfa-2b) | Intervention Type: BIOLOGICAL; Name: Recombinant Interferon Alfa-2b; Assigned to Arm(s): Arm II (octreotide acetate and recombinant interferon alfa-2b)
B: Arm Label: Everolimus 10 mg/day; Type: EXPERIMENTAL; Interventions: Drug: Everolimus | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Everolimus Placebo | Intervention Type: DRUG; Name: Everolimus; Assigned to Arm(s): Everolimus 10 mg/day | Intervention Type: DRUG; Name: Everolimus Placebo; Assigned to Arm(s): Placebo
C: Arm Label: A; Type: EXPERIMENTAL; Interventions: Drug: sunitinib malate | Arm Label: B; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: sunitinib malate; Assigned to Arm(s): A | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): B
D: Arm Label: 250 mg Telotristat Etiprate; Type: EXPERIMENTAL; Interventions: Drug: Telotristat etiprate, Drug: Placebo | Arm Label: 500 mg Telotristat Etiprate; Type: EXPERIMENTAL; Interventions: Drug: Telotristat etiprate, Drug: Placebo | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Telotristat etiprate; Assigned to Arm(s): 250 mg Telotristat Etiprate, 500 mg Telotristat Etiprate | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 250 mg Telotristat Etiprate, 500 mg Telotristat Etiprate, Placebo

Answer: C