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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01525550
• Date of registration: 13/01/2012
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: A Study Of The Efficacy And Safety Of Sunitinib In Patients With Advanced Well-Differentiated Pancreatic Neuroendocrine Tumors
• Scientific 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
• Date of first enrolment: June 6, 2012
• Target sample size: 106
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01525550
• Study type: Interventional
• Study design: Primary purpose: Other. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Australia, Belgium, China, Czech Republic, Czechia, Estonia, France, Hungary, India, Italy, Japan, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, South Africa, Spain, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Well-differentiated Pancreatic Neuroendocrine Tumor

Intervention(s)

Drug: sunitinib

Primary Outcome(s)

Progression-Free Survival (PFS): Investigator Assessment [Time Frame: Baseline until disease progression or death due to any cause (up to 1226 days)]

Secondary Outcome(s)

Plasma Concentration of Soluble Protein Biomarker (sKIT) [Time Frame: 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)]

Dose-Corrected Trough Plasma Concentration of Sunitinib and Its Metabolite SU012662 [Time Frame: Pre dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5]

Number of Participants With Adverse Events (AEs) According to Severity [Time Frame: Baseline up to 1939 days]

Overall Survival (OS) [Time Frame: Baseline until death or end of study (up to 1939 days)]

Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS) [Time Frame: 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)]

Percentage of Participants With Chromogranin A (CgA) Response [Time Frame: Baseline until CgA response or death due to any cause (up to 1226 days)]

Progression-Free Survival (PFS): Independent Radiological Review (IRR) Assessment [Time Frame: Baseline until disease progression or death due to any cause (up to 1226 days)]

Number of Participants With Increase From Baseline in Corrected QT Interval (QTc) [Time Frame: Baseline up to 1939 days]

Minimum Observed Plasma Concentration (Ctrough) of Sunitinib and Its Metabolite SU012662 [Time Frame: Pre-dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5]

Time to Tumor Progression (TTP): Investigator Assessment [Time Frame: Baseline until first documented tumor progression (up to 1226 days)]

Time to Tumor Response (TTR): Investigator Assessment [Time Frame: Baseline until first documented objective tumor response (up to 1226 days)]

Duration of Response (DOR): Investigator Assessment [Time Frame: Baseline until disease progression or death due to any cause (up to 1226 days)]

Number of Participants With Clinically Significant Laboratory Abnormalities [Time Frame: Baseline up to 1939 days]

Percentage of Participants With Objective Response (OR): Investigator Assessment [Time Frame: Baseline until disease progression or death due to any cause (up to 1226 days)]

Area Under the Curve (AUC24) of Sunitinib and Its Metabolite SU012662 [Time Frame: 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)]

Number of Participants With Change From Baseline in Body Weight [Time Frame: Baseline up to 1939 days]

Percentage of Participants With Objective Response (OR): Independent Radiological Review (IRR) Assessment [Time Frame: Baseline until disease progression or death due to any cause (up to 1226 days)]

Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) [Time Frame: 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)]

Number of Participants With Change From Baseline in Physical Examinations Findings [Time Frame: Baseline up to 1939 days]

Number of Participants With Change From Baseline in Vital Signs Abnormalities [Time Frame: Baseline up to 1939 days]

Time to Tumor Response (TTR): Independent Radiological Review (IRR) Assessment [Time Frame: Baseline until first documented objective tumor response (up to 1226 days)]

Duration of Response (DOR): Independent Radiological Review (IRR) Assessment [Time Frame: Baseline until disease progression or death due to any cause (up to 1226 days)]

Half Maximal Effective Concentration (EC50) of Sunitinib [Time Frame: Pre dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5 (each cycle 28 days)]

Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: Baseline up to 1939 days]

Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: Baseline up to 1939 days]

Oral Clearance (CL/F) of Sunitinib and Its Metabolite SU012662 [Time Frame: Pre dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5 (each cycle 28 days)]

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) [Time Frame: 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)]

Secondary ID(s)

2011-004363-74

A6181202

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 19/05/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01525550