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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01121562
First Posted: May 12, 2010
Last Update Posted: June 30, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
May 10, 2010
May 12, 2010
July 1, 2012
August 27, 2012
June 30, 2014
July 2010
July 2011   (Final data collection date for primary outcome measure)
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.

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 ]
Complete list of historical versions of study NCT01121562 on ClinicalTrials.gov Archive Site
  • 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.

  • 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 ]
Not Provided
Not Provided
 
Efficacy And Safety Of Sunitinib In Patients With Advanced Well-Differentiated Pancreatic Neuroendocrine Tumors
A Phase II Study Of Sunitinib In Patients With Progressive Advanced/Metastatic Well-Differentiated Pancreatic Neuroendocrine Tumors
The purpose of the study is to evaluate the effect of Sunitinib on the clinical benefit response rate.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pancreatic Neuroendocrine Tumors
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)
Experimental: Sunitinib arm
Intervention: Drug: Sunitinib
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
November 2013
July 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01121562
A6181193
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP