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Trial record 79 of 2749 for:    Neoplasms | Neuroendocrine Tumors

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

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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:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE May 10, 2010
First Posted Date  ICMJE May 12, 2010
Results First Submitted Date  ICMJE July 1, 2012
Results First Posted Date  ICMJE August 27, 2012
Last Update Posted Date June 30, 2014
Study Start Date  ICMJE July 2010
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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 ]
Change History Complete list of historical versions of study NCT01121562 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Efficacy And Safety Of Sunitinib In Patients With Advanced Well-Differentiated Pancreatic Neuroendocrine Tumors
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Neuroendocrine Tumors
Intervention  ICMJE 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  ICMJE 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 5, 2012)
12
Original Estimated Enrollment  ICMJE
 (submitted: May 10, 2010)
10
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01121562
Other Study ID Numbers  ICMJE A6181193
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2014

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