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

This study is currently recruiting participants.
Verified April 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01525550
First received: January 13, 2012
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to confirm the safety and efficacy of sunitinib in subjects with unresectable pancreatic neuroendocrine tumors.


Condition Intervention Phase
Well-differentiated Pancreatic Neuroendocrine Tumor
Drug: sunitinib
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Single Arm Open-Label International Multi Center Study Of The Efficacy And Safety Of Sunitinib Malate (SU011248, Sutent®) In Patients With Progressive Advanced Metastatic Well Differentiated Unresectable Pancreatic Neuroendocrine Tumors

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Progression-Free Survival (PFS) [ Time Frame: Baseline up to 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time-to-tumor progression (TTP) [ Time Frame: Baseline up to 2 years ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: Baseline until death (up to 2 years) ] [ Designated as safety issue: No ]
  • Objective response (OR) [ Time Frame: Baseline up to 2 years ] [ Designated as safety issue: No ]
  • Duration of response (DR) [ Time Frame: Baseline up to 2 years ] [ Designated as safety issue: No ]
  • Time-to-tumor response (TTR) [ Time Frame: Baseline up to 2 years ] [ Designated as safety issue: No ]
  • Evaluation of the use of Choi criteria [ Time Frame: Baseline up to 2 years ] [ Designated as safety issue: No ]
  • Evaluation of Chromogranin A response and soluble KIT concentrations [ Time Frame: Baseline up to 2 years ] [ Designated as safety issue: No ]
  • Pharmacokinetic trough plasma concentrations of sunitinib and its active metabolite (SU12662) [ Time Frame: 4 timepoints up to 5 months ] [ Designated as safety issue: No ]
  • Patient reported outcomes is defined as health related quality of life using the self administered European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (EORTC QLQ C30) and EORTC QLQ GI.NET21 [ Time Frame: Baseline up to 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: June 2012
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sunitinib Drug: sunitinib
Sunitinib capsules will be given orally at continuous daily dosing with a starting dose of 37.5 mg. One cycle is equal to 28 days.

Detailed Description:

This study is being conducted to meet regulatory post-marketing commitments.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically proven diagnosis of well-differentiated pancreatic neuroendocrine tumor (according to World Health Organization [WHO 2000] classification).
  • Disease progression within 12 months prior to study enrollment.
  • Disease that is not amenable to surgery, radiation, or combined modality therapy with curative intent.

Exclusion Criteria:

  • Patients with poorly differentiated pancreatic neuroendocrine tumors (according to WHO 2000 classification).
  • Prior treatment with any tyrosine kinase inhibitors, anti vascular endothelial growth factor (VEGF) angiogenesis inhibitors, non VEGF targeted angiogenesis inhibitors, or mammalian target of rapamycin (mTOR) inhibitors.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01525550

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 36 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01525550     History of Changes
Other Study ID Numbers: A6181202
Study First Received: January 13, 2012
Last Updated: April 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
neuroendocrine tumors
adenoma islet cells
carcinoma islet cells
pancreatic neoplasms
angiogenesis inhibitors
sunitinib
neoplasms
carcinoma
adenoma

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
Angiogenesis Inhibitors
Sunitinib
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 14, 2014