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

• 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: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 12 participants
• Allocation: N/A
• 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

Arms and Interventions

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)

Outcome Measures

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.

Eligibility Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• 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

Contacts and Locations

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:

To obtain contact information for a study center near you, click here. 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01121562
• Other Study ID Numbers: A6181193
• First Posted: May 12, 2010
• 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; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; 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; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action