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Completed

NCT Number: NCT01121562

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

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

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Key information

Conditions

Pancreatic Neuroendocrine Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Aichi Cancer Center Central Hospital, Nagoya, Aichi-ken, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sunitinib

Drug

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase II Study Of Sunitinib In Patients With Progressive Advanced/Metastatic Well-Differentiated Pancreatic Neuroendocrine Tumors

Important dates

Study start
2010
Primary completion
2011
Study completion
2013
First posted
May 12, 2010
Registry last updated
Jun 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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