Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical Benefit Response Rate (CBR)

Outcome Description:

CBR rate is defined as the percentage of participants with a best overall response of confirmed complete response (CR), confirmed partial response (PR) ,or stable disease (SD) ≥ 24 weeks. Based on RECIST, CR is defined as the disappearance of all target lesions and PR is defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesion. SD is defined neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest dimensions since the treatment started.

Outcome Time Frame:

Up to 12 cycles (1 cycle=4 weeks)

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

A6181193

NCT ID:

NCT01121562

Start Date:

July 2010

Completion Date:

December 2013

Related Keywords:

• Pancreatic Neuroendocrine Tumors
• Neuroendocrine tumors
• Neuroendocrine Tumors
• Adenoma, Islet Cell