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Trial record 1 of 1 for:    A6181193
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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

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

Condition or disease Intervention/treatment Phase
Pancreatic Neuroendocrine Tumors Drug: Sunitinib Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study Of Sunitinib In Patients With Progressive Advanced/Metastatic Well-Differentiated Pancreatic Neuroendocrine Tumors
Study Start Date : July 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : November 2013


Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.




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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
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
First Posted: May 12, 2010    Key Record Dates
Results First Posted: August 27, 2012
Last Update Posted: June 30, 2014
Last Verified: June 2014

Keywords provided by Pfizer:
Neuroendocrine tumors

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