Clinical trial NCT01525550: A Study Of The Efficacy And Safety Of Sunitinib In Patients With Advanced Well-Differentiated Pancreatic Neuroendocrine Tumors
Official title: A SINGLE-ARM OPEN-LABEL INTERNATIONAL MULTI-CENTER STUDY OF THE EFFICACY AND SAFETY OF SUNITINIB MALATE (SU011248, SUTENT (REGISTERED)) IN PATIENTS WITH PROGRESSIVE ADVANCED METASTATIC WELL-DIFFERENTIATED UNRESECTABLE PANCREATIC NEUROENDOCRINE TUMORS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Well-differentiated Pancreatic Neuroendocrine Tumor
Keywords: neuroendocrine tumors
adenoma islet cells
carcinoma islet cells
pancreatic neoplasms
angiogenesis inhibitors
sunitinib
neoplasms
carcinoma
adenoma
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-02-03
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: OTHER

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

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

Eligibility 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.

Primary outcomes:
measure: Progression-Free Survival (PFS): Investigator Assessment
timeFrame: Baseline until disease progression or death due to any cause (up to 1226 days)
Secondary outcomes:
measure: Progression-Free Survival (PFS): Independent Radiological Review (IRR) Assessment
timeFrame: Baseline until disease progression or death due to any cause (up to 1226 days)
measure: Time to Tumor Progression (TTP): Investigator Assessment
timeFrame: Baseline until first documented tumor progression (up to 1226 days)
measure: Overall Survival (OS)
timeFrame: Baseline until death or end of study (up to 1939 days)
measure: Percentage of Participants With Objective Response (OR): Investigator Assessment
timeFrame: Baseline until disease progression or death due to any cause (up to 1226 days)
measure: Duration of Response (DOR): Investigator Assessment
timeFrame: Baseline until disease progression or death due to any cause (up to 1226 days)
measure: Time to Tumor Response (TTR): Investigator Assessment
timeFrame: Baseline until first documented objective tumor response (up to 1226 days)
measure: Percentage of Participants With Objective Response (OR): Independent Radiological Review (IRR) Assessment
timeFrame: Baseline until disease progression or death due to any cause (up to 1226 days)
measure: Duration of Response (DOR): Independent Radiological Review (IRR) Assessment
timeFrame: Baseline until disease progression or death due to any cause (up to 1226 days)
measure: Time to Tumor Response (TTR): Independent Radiological Review (IRR) Assessment
timeFrame: Baseline until first documented objective tumor response (up to 1226 days)
measure: Percentage of Participants With Chromogranin A (CgA) Response
timeFrame: Baseline until CgA response or death due to any cause (up to 1226 days)
measure: Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
timeFrame: Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, End of treatment (up to maximum duration of 1226 days)
measure: Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
timeFrame: Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, End of treatment (up to maximum duration of 1226 days)
measure: Plasma Concentration of Soluble Protein Biomarker (sKIT)
timeFrame: Pre-dose on Day 1 and 15 of Cycle 1, Day 1 of Cycle 2, 3 and every 2 cycles thereafter (Cycle 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, 37, 39, 41, 43), End of Treatment (up to maximum duration of 1226 days)
measure: Minimum Observed Plasma Concentration (Ctrough) of Sunitinib and Its Metabolite SU012662
timeFrame: Pre-dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5
measure: Dose-Corrected Trough Plasma Concentration of Sunitinib and Its Metabolite SU012662
timeFrame: Pre dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5
measure: Area Under the Curve (AUC24) of Sunitinib and Its Metabolite SU012662
timeFrame: Pre-dose (0 hour) and at multiple time points (up to 24 hours) post dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5 (each cycle 28 days)
measure: Oral Clearance (CL/F) of Sunitinib and Its Metabolite SU012662
timeFrame: Pre dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5 (each cycle 28 days)
measure: Half Maximal Effective Concentration (EC50) of Sunitinib
timeFrame: Pre dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5 (each cycle 28 days)
measure: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 1939 days
measure: Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 1939 days
measure: Number of Participants With Adverse Events (AEs) According to Severity
timeFrame: Baseline up to 1939 days
measure: Number of Participants With Clinically Significant Laboratory Abnormalities
timeFrame: Baseline up to 1939 days
measure: Number of Participants With Change From Baseline in Vital Signs Abnormalities
timeFrame: Baseline up to 1939 days
measure: Number of Participants With Increase From Baseline in Corrected QT Interval (QTc)
timeFrame: Baseline up to 1939 days
measure: Number of Participants With Change From Baseline in Physical Examinations Findings
timeFrame: Baseline up to 1939 days
measure: Number of Participants With Change From Baseline in Body Weight
timeFrame: Baseline up to 1939 days
measure: Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
timeFrame: Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, End of treatment (up to maximum duration of 1226 days)
Other outcomes:
Locations:
city: Orange
country: United States
facility: Univeristy of California
state: California
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Geelong
country: Australia
facility: Barwon Health - University Hospital Geelong
state: Victoria
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc, Gastroenterologie
state: Brussels Gewest
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: 307 Hospital of PLA
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Nanjing
country: China
facility: Nanjing Bayi Hospital
state: Jiangsu
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav
city: Praha 2
country: Czechia
facility: Fakultni poliklinika
city: Praha 2
country: Czechia
facility: Vseobecna Fakultni Nemocnice v Praze
city: Clichy Cedex
country: France
facility: Hôpital Beaujon
city: Budapest
country: Hungary
facility: Semmelweis Egyetem/II. Sz. Belgyogyaszati Klinika
city: Mumbai
country: India
facility: Tata Memorial Hospital
state: Maharashtra
city: Milano
country: Italy
facility: IEO Istituto Europeo di Oncologia, IRCCS
city: Fukuoka-shi
country: Japan
facility: Kyushu University Hospital
state: Fukuoka
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Oslo
country: Norway
facility: Oslo Universitetssykehus HF, Rikshospitalet
city: Craiova
country: Romania
facility: Centrul de Oncologie Sf. Nectarie
state: Dolj
city: Bucuresti
country: Romania
facility: Institutul Clinic Fundeni, Centrul de Gastroenterologie si Hepatologie
city: Bratislava
country: Slovakia
facility: Narodny Onkologicky ustav
city: Johannesburg
country: South Africa
facility: Wits Clinical Research
state: Gauteng
city: Madrid
country: Spain
facility: Hospital Universitario Madrid Sanchinarro - Centro Integral Oncológico Clara Campal (CIOCC)
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Fazio N, Kulke M, Rosbrook B, Fernandez K, Raymond E. Updated Efficacy and Safety Outcomes for Patients with Well-Differentiated Pancreatic Neuroendocrine Tumors Treated with Sunitinib. Target Oncol. 2021 Jan;16(1):27-35. doi: 10.1007/s11523-020-00784-0. Epub 2021 Jan 7.