Efficacy And Safety Of Sunitinib In Patients With Advanced Well-Differentiated Pancreatic Neuroendocrine Tumors
This study is ongoing, but not recruiting participants.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01121562
First received: May 10, 2010
Last updated: April 23, 2013
Last verified: April 2013
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Purpose
The purpose of the study is to evaluate the effect of Sunitinib on the clinical benefit response rate.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Neuroendocrine Tumors |
Drug: Sunitinib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study Of Sunitinib In Patients With Progressive Advanced/Metastatic Well-Differentiated Pancreatic Neuroendocrine Tumors |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Clinical Benefit Response Rate (CBR) [ Time Frame: Up to 12 cycles (1 cycle=4 weeks) ] [ Designated as safety issue: No ]
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:
- Objective Response Rate (ORR) [ Time Frame: Up to 12 cycles (1 cycle=4 weeks) ] [ Designated as safety issue: No ]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.
- Tumor Shrinkage [ Time Frame: Up to 12 cycles (1 cycle=4 weeks) ] [ Designated as safety issue: No ]Tumor shrinkage is defined as the percent change from baseline for the sum of the longest diameter of target lesions in participants.
- Progression-free Survival (PFS) [ Time Frame: Up to 12 cycles (1 cycle=4 weeks) ] [ Designated as safety issue: No ]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.
- Overall Survival (OS) [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]Overall Survival (OS) is defined as the time from registration to documentation of death due to any cause.
- 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 ] [ Designated as safety issue: No ]
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.
| Enrollment: | 12 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | December 2013 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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)
|
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01121562
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:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01121562 History of Changes |
| Other Study ID Numbers: | A6181193 |
| Study First Received: | May 10, 2010 |
| Results First Received: | July 1, 2012 |
| Last Updated: | April 23, 2013 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Keywords provided by Pfizer:
|
Neuroendocrine tumors |
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 Sunitinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013