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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01121562
First received: May 10, 2010
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

The purpose of the study is to evaluate the effect of Sunitinib on the clinical benefit response rate.


Condition Intervention Phase
Pancreatic Neuroendocrine Tumors
Drug: Sunitinib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Of Sunitinib In Patients With Progressive Advanced/Metastatic Well-Differentiated Pancreatic Neuroendocrine Tumors

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Clinical Benefit Response Rate (CBR) [ Time Frame: Up to 799 days of treatment ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Objective Response Rate (ORR) [ Time Frame: Up to 799 days of treatment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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.



Enrollment: 12
Study Start Date: July 2010
Study Completion Date: November 2013
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sunitinib arm 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)

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01121562

Locations
Japan
Aichi Cancer Center Central Hospital
Nagoya, Aichi, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
Kyushu University Hospital
Fukuoka, Japan
Osaka Police Hospital
Osaka, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01121562     History of Changes
Other Study ID Numbers: A6181193
Study First Received: May 10, 2010
Results First Received: July 1, 2012
Last Updated: June 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Neuroendocrine tumors

Additional relevant MeSH terms:
Adenoma, Islet Cell
Neoplasms
Neuroendocrine Tumors
Adenoma
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Pancreatic Diseases
Pancreatic Neoplasms
Sunitinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014