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 May 2013 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01525550
First received: January 13, 2012
Last updated: May 3, 2013
Last verified: May 2013
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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
Show 27 Study Locations
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 | |
| Contact: Pfizer Oncology Clinical Trial Information Service | 1-877-369-9753 | PfizerCancerTrials@emergingmed.com |
Show 27 Study LocationsSponsors 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: | May 3, 2013 |
| 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 May 22, 2013