Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01121562
Other study ID # A6181193
Secondary ID
Status Completed
Phase Phase 2
First received May 10, 2010
Last updated June 18, 2014
Start date July 2010
Est. completion date November 2013

Study information

Verified date June 2014
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date November 2013
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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)

Locations

Country Name City State
Japan National Cancer Center Hospital Chuo-ku Tokyo
Japan Kyushu University Hospital Fukuoka
Japan Aichi Cancer Center Central Hospital Nagoya Aichi
Japan Osaka Police Hospital Osaka

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical Benefit Response Rate (CBR) 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.
Up to 799 days of treatment No
Secondary Objective Response Rate (ORR) 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. Up to 799 days of treatment No
Secondary Tumor Shrinkage Tumor shrinkage is defined as the percent change from baseline for the sum of the longest diameter of target lesions in participants. Up to 799 days of treatment No
Secondary Progression-free Survival (PFS) 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. Up to 799 days of treatment No
Secondary Overall Survival (OS) Overall Survival (OS) is defined as the time from registration to documentation of death due to any cause. Up to 3 years from the last subject registration to the study No
Secondary Dose-corrected Trough Plasma Concentrations of Sunitinib, SU012662 and Total Drug (Sunitinib + SU012662). 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.
Predose of Cycle 1 Day15, Cycle 2 Day1, Cycle 3 Day1, and Cycle 4 Day 1 No
See also
  Status Clinical Trial Phase
Recruiting NCT03053999 - Variables That Are Correlated to Developing Multiple Endocrine Neoplasia (MEN) and Pancreatic Neuroendocrine Tumors (PNET)
Completed NCT02586844 - Prospective Comprehensive Molecular Profiling In Neuroendocrine Tumors
Terminated NCT00947167 - A Phase II Study of Pertuzumab and Erlotinib for Metastatic or Unresectable Neuroendocrine Tumors Phase 2
Completed NCT02842749 - Phase IV Study of the Safety and Efficacy of Everolimus in Adult Patients With Progressive pNET in China Phase 4
Unknown status NCT01381822 - Dose-Escalation Study of TH-302 in Combination With Sunitinib to Treat Patients With Advanced Renal Cell Carcinoma,Gastrointestinal Stromal Tumors and Pancreatic Neuroendocrine Tumors Phase 1
Completed NCT01384617 - Trial Assessing Roux-en-Y Anastomosis of the Pancreatic Stump to Prevent Pancreatic Fistula Following Distal Pancreatectomy N/A
Completed NCT02841865 - Radiological Response of Pancreatic Neuroendocrine Tumors: Comparison Between the Choi and the RECIST Criteria
Completed NCT02685553 - Near Infrared Technology and Laparoscopic Resection of Pancreatic Lesions: the COLPAN Project Phase 1
Completed NCT02282059 - The Safety And Efficacy Of Sunitinib In Chinese Patients With Progressive Advanced Or Metastatic Well-Differentiated Unresectable Pancreatic Neuroendocrine Tumors
Terminated NCT01648465 - Study of Everolimus Treatment in Newly-diagnosed Patients With Advanced Gastrointestinal Neuroendocrine Tumors Phase 2
Terminated NCT02110563 - Phase I, Multicenter, Dose Escalation Study of DCR-MYC in Patients With Solid Tumors, Multiple Myeloma, or Lymphoma Phase 1
Completed NCT02125929 - Comparative Study of Robotic, Laparoscopic and Open Surgery for Enucleation of Benign Pancreatic Neoplasms N/A