Efficacy And Safety Of Sunitinib In Patients With Advanced Well-Differentiated Pancreatic Neuroendocrine Tumors

• ClinicalTrials.gov Identifier: NCT01121562
• Recruitment Status: Completed
• First Posted: May 12, 2010
• Results First Posted: August 27, 2012
• Last Update Posted: June 30, 2014
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: May 10, 2010
• First Posted Date: May 12, 2010
• Results First Submitted Date: July 1, 2012
• Results First Posted Date: August 27, 2012
• Last Update Posted Date: June 30, 2014
• Study Start Date: July 2010
• Actual Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 18, 2014)

Clinical Benefit Response Rate (CBR) [ Time Frame: Up to 799 days of treatment ]

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.

• Original Primary Outcome Measures (submitted: May 10, 2010): Clinical benefit response rate is defined as the percent of patients with CR, PR or SD with time to treatment failure >= 24 weeks according to the RECIST guidelines, relative to the total analysis population. [ Time Frame: 24 weeks ]

Current Secondary Outcome Measures (submitted: June 18, 2014)

• Objective Response Rate (ORR) [ Time Frame: Up to 799 days of treatment ]
  ORR is defined as the percentage of participants with a best overall response of confirmed CR or confirmed PR. Based on the response evaluation criteria in solid tumors (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.
• Tumor Shrinkage [ Time Frame: Up to 799 days of treatment ]
  Tumor shrinkage is defined as the percent change from baseline for the sum of the longest diameter of target lesions in participants.
• Progression-free Survival (PFS) [ Time Frame: Up to 799 days of treatment ]
  PFS is defined as the time from registration to first documentation of progressive disease (PD) or to death due to any cause, whichever occurs first.
• Overall Survival (OS) [ Time Frame: Up to 3 years from the last subject registration to the study ]
  Overall Survival (OS) is defined as the time from registration to documentation of death due to any cause.
• Dose-corrected Trough Plasma Concentrations of Sunitinib, SU012662 and Total Drug (Sunitinib + SU012662). [ Time Frame: Predose of Cycle 1 Day15, Cycle 2 Day1, Cycle 3 Day1, and Cycle 4 Day 1 ]
  Reference dose is 37.5 mg. Dose-corrected concentration is calculated from the following formula, "observed concentration multiplied by 37.5" over "actual dose". SU012662 is an active metabolite of sunitinib.

Original Secondary Outcome Measures (submitted: May 10, 2010)

• Objective response rate (ORR) is defined as the percent of patients with confirmed CR or confirmed PR relative to the total analysis population. [ Time Frame: 24 weeks ]
• Tumor shrinkage is defined as the percent change from baseline for the sum of the longest diameter of target lesions [ Time Frame: 24 weeks ]
• Progression-free survival (PFS) is defined as the time from randomization to first documentation of objective tumor progression or to death due to any cause, whichever occurs first. [ Time Frame: 2 years ]
• Time-to-tumor-progression (TTP) is defined as the time from randomization to first documentation of objective tumor progression. [ Time Frame: 2 years ]
• Overall Survival (OS) is defined as the time from randomization to documentation of death due to any cause. [ Time Frame: 2 years ]
• Safety: AE incidence, severity, seriousness, relationship and laboratory data. [ Time Frame: 2 years ]
• PK: Trough plasma concentrations of sunitinib, SU012662 and total drug (sunitinib + SU012662). [ Time Frame: 4 months ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy And Safety Of Sunitinib In Patients With Advanced Well-Differentiated Pancreatic Neuroendocrine Tumors
• Official Title: A Phase II Study Of Sunitinib In Patients With Progressive Advanced/Metastatic Well-Differentiated Pancreatic Neuroendocrine Tumors
• Brief Summary: The purpose of the study is to evaluate the effect of Sunitinib on the clinical benefit response rate.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Pancreatic Neuroendocrine Tumors

Intervention

Drug: Sunitinib

Sunitinib capsule will be given orally at continuous daily dosing with a dose of 37.5 mg in the morning (regardless fasting or non-fasting, One cycle will be 28days)

Study Arms

Experimental: Sunitinib arm

Intervention: Drug: Sunitinib

• Publications *: Ito T, Okusaka T, Nishida T, Yamao K, Igarashi H, Morizane C, Kondo S, Mizuno N, Hara K, Sawaki A, Hashigaki S, Kimura N, Murakami M, Ohki E, Chao RC, Imamura M. Phase II study of sunitinib in Japanese patients with unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumor. Invest New Drugs. 2013 Oct;31(5):1265-74. doi: 10.1007/s10637-012-9910-y. Epub 2012 Dec 27. Erratum In: Invest New Drugs. 2019 Jun;37(3):591.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 5, 2012): 12
• Original Estimated Enrollment (submitted: May 10, 2010): 10
• Actual Study Completion Date: November 2013
• Actual Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patients must have advanced (unresectable or metastatic) biopsy-proven pancreatic NET (Neuroendocrine Tumor)

Exclusion Criteria:

• Patients with poorly differentiated neuroendocrine cancer are not eligible

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT01121562
• Other Study ID Numbers: A6181193
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Pfizer
• Original Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
• Current Study Sponsor: Pfizer
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: June 2014