Trial Outcomes & Findings for The Safety And Efficacy Of Sunitinib In Chinese Patients With Progressive Advanced Or Metastatic Well-Differentiated Unresectable Pancreatic Neuroendocrine Tumors (NCT NCT02282059)
NCT ID: NCT02282059
Last Updated: 2024-06-20
Results Overview
An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product. The event did not necessarily need to have a causal relationship with the product treatment or usage. A TEAE was defined as an event that emerged during treatment, having been absent pretreatment, or worsened relative to the pretreatment state.
Recruitment status
COMPLETED
Target enrollment
100 participants
Primary outcome timeframe
From baseline up to 8 years
Results posted on
2024-06-20
Participant Flow
A total of 100 participants were enrolled and assigned to the study treatment, and 99 participants were treated.
Participant milestones
| Measure |
Sunitinib (Not Taken)
Sunitinib (Not Taken) were the participants with progressive, unresectable, advanced or metastatic well-differentiated pancreatic neuroendocrine tumors who would accept sunitinib therapy when signing informed consent.
|
Sunitinib (Already Taken)
Sunitinib (Already Taken) were the participants with progressive, unresectable, advanced or metastatic well-differentiated pancreatic neuroendocrine tumors who had already taken sunitinib within the past 6 months (26 weeks) when signing informed consent and would continue sunitinib therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
82
|
18
|
|
Overall Study
Treated
|
81
|
18
|
|
Overall Study
Discontinued
|
82
|
18
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
82
|
18
|
Reasons for withdrawal
| Measure |
Sunitinib (Not Taken)
Sunitinib (Not Taken) were the participants with progressive, unresectable, advanced or metastatic well-differentiated pancreatic neuroendocrine tumors who would accept sunitinib therapy when signing informed consent.
|
Sunitinib (Already Taken)
Sunitinib (Already Taken) were the participants with progressive, unresectable, advanced or metastatic well-differentiated pancreatic neuroendocrine tumors who had already taken sunitinib within the past 6 months (26 weeks) when signing informed consent and would continue sunitinib therapy.
|
|---|---|---|
|
Overall Study
Other
|
15
|
3
|
|
Overall Study
Participant refused further follow-up
|
8
|
4
|
|
Overall Study
Lost to Follow-up
|
19
|
3
|
|
Overall Study
Death
|
40
|
8
|
Baseline Characteristics
The Safety And Efficacy Of Sunitinib In Chinese Patients With Progressive Advanced Or Metastatic Well-Differentiated Unresectable Pancreatic Neuroendocrine Tumors
Baseline characteristics by cohort
| Measure |
Sunitinib (Not Taken)
n=81 Participants
Sunitinib (Not Taken) were the participants with progressive, unresectable, advanced or metastatic well-differentiated pancreatic neuroendocrine tumors who would accept sunitinib therapy when signing informed consent.
|
Sunitinib (Already Taken)
n=18 Participants
Sunitinib (Already Taken) were the participants with progressive, unresectable, advanced or metastatic well-differentiated pancreatic neuroendocrine tumors who had already taken sunitinib within the past 6 months (26 weeks) when signing informed consent and would continue sunitinib therapy.
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.0 Years
n=99 Participants
|
49.0 Years
n=107 Participants
|
51.0 Years
n=206 Participants
|
|
Age, Customized
<18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Customized
18-44 years
|
26 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Age, Customized
45-64 years
|
40 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Age, Customized
>=65 years
|
15 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
81 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
99 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From baseline up to 8 yearsPopulation: The safety analysis population included all enrolled participants who took at least 1 dose of the study drug.
An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product. The event did not necessarily need to have a causal relationship with the product treatment or usage. A TEAE was defined as an event that emerged during treatment, having been absent pretreatment, or worsened relative to the pretreatment state.
Outcome measures
| Measure |
Sunitinib (Not Taken)
n=81 Participants
Sunitinib (Not Taken) were the participants with progressive, unresectable, advanced or metastatic well-differentiated pancreatic neuroendocrine tumors who would accept sunitinib therapy when signing informed consent.
|
Sunitinib (Already Taken)
n=18 Participants
Sunitinib (Already Taken) were the participants with progressive, unresectable, advanced or metastatic well-differentiated pancreatic neuroendocrine tumors who had already taken sunitinib within the past 6 months (26 weeks) when signing informed consent and would continue sunitinib therapy.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causalities and Treatment-related)
All-causality TEAEs
|
61 Participants
|
13 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causalities and Treatment-related)
Treatment-related TEAEs
|
52 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: From baseline up to 8 yearsPopulation: The safety analysis population included all enrolled participants who took at least 1 dose of the study drug.
An SAE was any untoward medical occurrence in a participant administered a medicinal at any dose that resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect.
Outcome measures
| Measure |
Sunitinib (Not Taken)
n=81 Participants
Sunitinib (Not Taken) were the participants with progressive, unresectable, advanced or metastatic well-differentiated pancreatic neuroendocrine tumors who would accept sunitinib therapy when signing informed consent.
|
Sunitinib (Already Taken)
n=18 Participants
Sunitinib (Already Taken) were the participants with progressive, unresectable, advanced or metastatic well-differentiated pancreatic neuroendocrine tumors who had already taken sunitinib within the past 6 months (26 weeks) when signing informed consent and would continue sunitinib therapy.
|
|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) (All Causalities and Treatment-related)
All-causality SAEs
|
11 Participants
|
5 Participants
|
|
Number of Participants With Serious Adverse Events (SAEs) (All Causalities and Treatment-related)
Treatment-related SAEs
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From baseline up to 8 yearsPopulation: The safety analysis population included all enrolled participants who took at least 1 dose of the study drug. Participants with missing first dosing date were excluded from analysis.
Laboratory abnormalities assessment included: hematologic: hemoglobin, platelet count, white blood cell (WBC) count, neutrophile granulocyte count; non-hematologic: total bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, gamma-glutamyl transferase (GGT), total protein, albumin, blood urea nitrogen (BUN), creatinine, uric acid, glucose, hypocalcemia, hyponatremia, hypophosphatemia, hypokalaemia.
Outcome measures
| Measure |
Sunitinib (Not Taken)
n=81 Participants
Sunitinib (Not Taken) were the participants with progressive, unresectable, advanced or metastatic well-differentiated pancreatic neuroendocrine tumors who would accept sunitinib therapy when signing informed consent.
|
Sunitinib (Already Taken)
n=18 Participants
Sunitinib (Already Taken) were the participants with progressive, unresectable, advanced or metastatic well-differentiated pancreatic neuroendocrine tumors who had already taken sunitinib within the past 6 months (26 weeks) when signing informed consent and would continue sunitinib therapy.
|
|---|---|---|
|
Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4
Anemia (Grade 0 to Grade 3)
|
2 Participants
|
2 Participants
|
|
Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4
Anemia (Grade 1 to Grade 3)
|
1 Participants
|
1 Participants
|
|
Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4
Anemia (Grade 2 to Grade 3)
|
4 Participants
|
1 Participants
|
|
Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4
Lymphocyte count decreased (Grade 0 to Grade 3)
|
4 Participants
|
1 Participants
|
|
Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4
Lymphocyte count decreased (Grade 1 to Grade 3)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4
Lymphocyte count decreased (Grade 2 to Grade 3)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4
Neutrophil count decreased (Grade 0 to Grade 3)
|
7 Participants
|
3 Participants
|
|
Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4
Neutrophil count decreased (Grade 1 to Grade 3)
|
1 Participants
|
1 Participants
|
|
Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4
Neutrophil count decreased (Grade 1 to Grade 4)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4
Platelet count decreased (Grade 0 to Grade 3)
|
2 Participants
|
1 Participants
|
|
Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4
Platelet count decreased (Grade 1 to Grade 3)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4
Platelet count decreased (Grade 0 to Grade 4)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4
Platelet count decreased (Grade 1 to Grade 4)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4
WBC decreased (Grade 0 to Grade 3)
|
4 Participants
|
1 Participants
|
|
Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4
WBC decreased (Grade 1 to Grade 3)
|
1 Participants
|
1 Participants
|
|
Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4
WBC decreased (Grade 1 to Grade 4)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4
ALT increased (Grade 0 to Grade 3)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4
ALT increased (Grade 1 to Grade 3)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4
ALT increased (Grade 2 to Grade 3)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4
Alkaline phosphatase increased (Grade 0 to Grade 3)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4
Alkaline phosphatase increased (Grade 1 to Grade 3)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4
AST increased (Grade 1 to Grade 3)
|
2 Participants
|
0 Participants
|
|
Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4
Blood bilirubin increased (Grade 0 to Grade 3)
|
3 Participants
|
0 Participants
|
|
Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4
Blood bilirubin increased (Grade 2 to Grade 3)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4
GGT increased (Grade 1 to Grade 3)
|
4 Participants
|
0 Participants
|
|
Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4
GGT increased (Grade 2 to Grade 3)
|
4 Participants
|
1 Participants
|
|
Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4
GGT increased (Grade 0 to Grade 4)
|
1 Participants
|
1 Participants
|
|
Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4
Hyperglycemia (Garde 0 to Grade 3)
|
2 Participants
|
0 Participants
|
|
Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4
Hypocalcemia (Garde 0 to Grade 3)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4
Hypokalemia (Garde 0 to Grade 3)
|
4 Participants
|
0 Participants
|
|
Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4
Hypokalemia (Garde 2 to Grade 3)
|
2 Participants
|
0 Participants
|
|
Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4
Hypokalemia (Garde 2 to Grade 4)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4
Hyponatremia (Garde 0 to Grade 3)
|
2 Participants
|
0 Participants
|
|
Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4
Hypophosphatemia (Garde 0 to Grade 3)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4
Hypophosphatemia (Garde 2 to Grade 3)
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From baseline up to 8 yearsPopulation: The analysis population included all participants who took at least 1 dose of the study drug.
Investigator assessed PFS according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.6. PFS was defined as the time from the start of sunitinib treatment to first document of objective tumor progression or death due to any cause, whichever occurred first. Progression was defined using RECIST v1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Sunitinib (Not Taken)
n=81 Participants
Sunitinib (Not Taken) were the participants with progressive, unresectable, advanced or metastatic well-differentiated pancreatic neuroendocrine tumors who would accept sunitinib therapy when signing informed consent.
|
Sunitinib (Already Taken)
n=18 Participants
Sunitinib (Already Taken) were the participants with progressive, unresectable, advanced or metastatic well-differentiated pancreatic neuroendocrine tumors who had already taken sunitinib within the past 6 months (26 weeks) when signing informed consent and would continue sunitinib therapy.
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
10.4 Months
Interval 4.6 to
Upper limit of the 95% Confidence Interval was not estimable due to an insufficient number of participants with events.
|
25.5 Months
Interval 8.3 to 42.7
|
SECONDARY outcome
Timeframe: From baseline up to 8 yearsPopulation: The analysis population included all participants who took at least 1 dose of the study drug.
PFS by clinical judgment was defined as the time from the start of sunitinib treatment to first document of objective tumor progression, or first time tumor progression diagnosed by investigator based on clinical judgment, or death due to any cause, whichever occurred first. Progression was defined using RECIST v1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Sunitinib (Not Taken)
n=81 Participants
Sunitinib (Not Taken) were the participants with progressive, unresectable, advanced or metastatic well-differentiated pancreatic neuroendocrine tumors who would accept sunitinib therapy when signing informed consent.
|
Sunitinib (Already Taken)
n=18 Participants
Sunitinib (Already Taken) were the participants with progressive, unresectable, advanced or metastatic well-differentiated pancreatic neuroendocrine tumors who had already taken sunitinib within the past 6 months (26 weeks) when signing informed consent and would continue sunitinib therapy.
|
|---|---|---|
|
Progression-Free Survival by Clinical Judgment
|
10.4 Months
Interval 4.6 to 27.6
|
42.7 Months
Interval 3.8 to 42.7
|
SECONDARY outcome
Timeframe: From baseline up to 8 yearsPopulation: The analysis population included all participants who took at least 1 dose of the study drug.
OS was defined as the time from the start of sunitinib treatment to documentation of death due to any cause.
Outcome measures
| Measure |
Sunitinib (Not Taken)
n=81 Participants
Sunitinib (Not Taken) were the participants with progressive, unresectable, advanced or metastatic well-differentiated pancreatic neuroendocrine tumors who would accept sunitinib therapy when signing informed consent.
|
Sunitinib (Already Taken)
n=18 Participants
Sunitinib (Already Taken) were the participants with progressive, unresectable, advanced or metastatic well-differentiated pancreatic neuroendocrine tumors who had already taken sunitinib within the past 6 months (26 weeks) when signing informed consent and would continue sunitinib therapy.
|
|---|---|---|
|
Overall Survival (OS)
|
46.2 Months
Interval 30.0 to 77.9
|
NA Months
Interval 14.7 to
Upper limit of the 95% Confidence Interval was not estimable due to an insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: From baseline up to 8 yearsPopulation: The analysis population included all participants who took at least 1 dose of the study drug.
Five-year survival rate was defined as the proportion of participants who stayed alive till after 5 years from the start of sunitinib treatment.
Outcome measures
| Measure |
Sunitinib (Not Taken)
n=81 Participants
Sunitinib (Not Taken) were the participants with progressive, unresectable, advanced or metastatic well-differentiated pancreatic neuroendocrine tumors who would accept sunitinib therapy when signing informed consent.
|
Sunitinib (Already Taken)
n=18 Participants
Sunitinib (Already Taken) were the participants with progressive, unresectable, advanced or metastatic well-differentiated pancreatic neuroendocrine tumors who had already taken sunitinib within the past 6 months (26 weeks) when signing informed consent and would continue sunitinib therapy.
|
|---|---|---|
|
Five-Year Survival Rate
|
0.478 Proportion of participants
Interval 0.352 to 0.594
|
0.504 Proportion of participants
Interval 0.249 to 0.714
|
Adverse Events
Sunitinib (Not Taken)
Serious events: 11 serious events
Other events: 55 other events
Deaths: 40 deaths
Sunitinib (Already Taken)
Serious events: 5 serious events
Other events: 13 other events
Deaths: 8 deaths
Total
Serious events: 16 serious events
Other events: 68 other events
Deaths: 48 deaths
Serious adverse events
| Measure |
Sunitinib (Not Taken)
n=81 participants at risk
Sunitinib (Not Taken) were the participants with progressive, unresectable, advanced or metastatic well-differentiated pancreatic neuroendocrine tumors who would accept sunitinib therapy when signing informed consent.
|
Sunitinib (Already Taken)
n=18 participants at risk
Sunitinib (Already Taken) were the participants with progressive, unresectable, advanced or metastatic well-differentiated pancreatic neuroendocrine tumors who had already taken sunitinib within the past 6 months (26 weeks) when signing informed consent and would continue sunitinib therapy.
|
Total
n=99 participants at risk
(=sum per row)
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.2%
1/81 • From baseline up to 8 years
|
0.00%
0/18 • From baseline up to 8 years
|
1.0%
1/99 • From baseline up to 8 years
|
|
Blood and lymphatic system disorders
Myelosuppression
|
1.2%
1/81 • From baseline up to 8 years
|
0.00%
0/18 • From baseline up to 8 years
|
1.0%
1/99 • From baseline up to 8 years
|
|
Gastrointestinal disorders
Duodenal obstruction
|
1.2%
1/81 • From baseline up to 8 years
|
0.00%
0/18 • From baseline up to 8 years
|
1.0%
1/99 • From baseline up to 8 years
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.2%
1/81 • From baseline up to 8 years
|
0.00%
0/18 • From baseline up to 8 years
|
1.0%
1/99 • From baseline up to 8 years
|
|
General disorders
Death
|
1.2%
1/81 • From baseline up to 8 years
|
0.00%
0/18 • From baseline up to 8 years
|
1.0%
1/99 • From baseline up to 8 years
|
|
General disorders
Disease progression
|
2.5%
2/81 • From baseline up to 8 years
|
5.6%
1/18 • From baseline up to 8 years
|
3.0%
3/99 • From baseline up to 8 years
|
|
General disorders
Oedema peripheral
|
0.00%
0/81 • From baseline up to 8 years
|
5.6%
1/18 • From baseline up to 8 years
|
1.0%
1/99 • From baseline up to 8 years
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
1.2%
1/81 • From baseline up to 8 years
|
0.00%
0/18 • From baseline up to 8 years
|
1.0%
1/99 • From baseline up to 8 years
|
|
Infections and infestations
Biliary tract infection
|
1.2%
1/81 • From baseline up to 8 years
|
0.00%
0/18 • From baseline up to 8 years
|
1.0%
1/99 • From baseline up to 8 years
|
|
Injury, poisoning and procedural complications
Foreign body
|
0.00%
0/81 • From baseline up to 8 years
|
5.6%
1/18 • From baseline up to 8 years
|
1.0%
1/99 • From baseline up to 8 years
|
|
Investigations
Platelet count decreased
|
1.2%
1/81 • From baseline up to 8 years
|
0.00%
0/18 • From baseline up to 8 years
|
1.0%
1/99 • From baseline up to 8 years
|
|
Metabolism and nutrition disorders
Cachexia
|
3.7%
3/81 • From baseline up to 8 years
|
0.00%
0/18 • From baseline up to 8 years
|
3.0%
3/99 • From baseline up to 8 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/81 • From baseline up to 8 years
|
5.6%
1/18 • From baseline up to 8 years
|
1.0%
1/99 • From baseline up to 8 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.00%
0/81 • From baseline up to 8 years
|
5.6%
1/18 • From baseline up to 8 years
|
1.0%
1/99 • From baseline up to 8 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/81 • From baseline up to 8 years
|
5.6%
1/18 • From baseline up to 8 years
|
1.0%
1/99 • From baseline up to 8 years
|
Other adverse events
| Measure |
Sunitinib (Not Taken)
n=81 participants at risk
Sunitinib (Not Taken) were the participants with progressive, unresectable, advanced or metastatic well-differentiated pancreatic neuroendocrine tumors who would accept sunitinib therapy when signing informed consent.
|
Sunitinib (Already Taken)
n=18 participants at risk
Sunitinib (Already Taken) were the participants with progressive, unresectable, advanced or metastatic well-differentiated pancreatic neuroendocrine tumors who had already taken sunitinib within the past 6 months (26 weeks) when signing informed consent and would continue sunitinib therapy.
|
Total
n=99 participants at risk
(=sum per row)
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
23.5%
19/81 • From baseline up to 8 years
|
33.3%
6/18 • From baseline up to 8 years
|
25.3%
25/99 • From baseline up to 8 years
|
|
Blood and lymphatic system disorders
Myelosuppression
|
3.7%
3/81 • From baseline up to 8 years
|
5.6%
1/18 • From baseline up to 8 years
|
4.0%
4/99 • From baseline up to 8 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.6%
7/81 • From baseline up to 8 years
|
27.8%
5/18 • From baseline up to 8 years
|
12.1%
12/99 • From baseline up to 8 years
|
|
Eye disorders
Eyelid oedema
|
1.2%
1/81 • From baseline up to 8 years
|
5.6%
1/18 • From baseline up to 8 years
|
2.0%
2/99 • From baseline up to 8 years
|
|
Gastrointestinal disorders
Abdominal distension
|
4.9%
4/81 • From baseline up to 8 years
|
5.6%
1/18 • From baseline up to 8 years
|
5.1%
5/99 • From baseline up to 8 years
|
|
Gastrointestinal disorders
Abdominal pain
|
8.6%
7/81 • From baseline up to 8 years
|
16.7%
3/18 • From baseline up to 8 years
|
10.1%
10/99 • From baseline up to 8 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.5%
2/81 • From baseline up to 8 years
|
11.1%
2/18 • From baseline up to 8 years
|
4.0%
4/99 • From baseline up to 8 years
|
|
Gastrointestinal disorders
Ascites
|
1.2%
1/81 • From baseline up to 8 years
|
5.6%
1/18 • From baseline up to 8 years
|
2.0%
2/99 • From baseline up to 8 years
|
|
Gastrointestinal disorders
Constipation
|
2.5%
2/81 • From baseline up to 8 years
|
11.1%
2/18 • From baseline up to 8 years
|
4.0%
4/99 • From baseline up to 8 years
|
|
Gastrointestinal disorders
Diarrhoea
|
8.6%
7/81 • From baseline up to 8 years
|
22.2%
4/18 • From baseline up to 8 years
|
11.1%
11/99 • From baseline up to 8 years
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/81 • From baseline up to 8 years
|
5.6%
1/18 • From baseline up to 8 years
|
1.0%
1/99 • From baseline up to 8 years
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/81 • From baseline up to 8 years
|
5.6%
1/18 • From baseline up to 8 years
|
1.0%
1/99 • From baseline up to 8 years
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/81 • From baseline up to 8 years
|
5.6%
1/18 • From baseline up to 8 years
|
1.0%
1/99 • From baseline up to 8 years
|
|
Gastrointestinal disorders
Mouth ulceration
|
1.2%
1/81 • From baseline up to 8 years
|
5.6%
1/18 • From baseline up to 8 years
|
2.0%
2/99 • From baseline up to 8 years
|
|
Gastrointestinal disorders
Nausea
|
7.4%
6/81 • From baseline up to 8 years
|
5.6%
1/18 • From baseline up to 8 years
|
7.1%
7/99 • From baseline up to 8 years
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
9/81 • From baseline up to 8 years
|
16.7%
3/18 • From baseline up to 8 years
|
12.1%
12/99 • From baseline up to 8 years
|
|
General disorders
Chest pain
|
0.00%
0/81 • From baseline up to 8 years
|
5.6%
1/18 • From baseline up to 8 years
|
1.0%
1/99 • From baseline up to 8 years
|
|
General disorders
Malaise
|
1.2%
1/81 • From baseline up to 8 years
|
5.6%
1/18 • From baseline up to 8 years
|
2.0%
2/99 • From baseline up to 8 years
|
|
General disorders
Oedema peripheral
|
3.7%
3/81 • From baseline up to 8 years
|
5.6%
1/18 • From baseline up to 8 years
|
4.0%
4/99 • From baseline up to 8 years
|
|
General disorders
Pyrexia
|
7.4%
6/81 • From baseline up to 8 years
|
0.00%
0/18 • From baseline up to 8 years
|
6.1%
6/99 • From baseline up to 8 years
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/81 • From baseline up to 8 years
|
5.6%
1/18 • From baseline up to 8 years
|
1.0%
1/99 • From baseline up to 8 years
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/81 • From baseline up to 8 years
|
5.6%
1/18 • From baseline up to 8 years
|
1.0%
1/99 • From baseline up to 8 years
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/81 • From baseline up to 8 years
|
5.6%
1/18 • From baseline up to 8 years
|
1.0%
1/99 • From baseline up to 8 years
|
|
Infections and infestations
Hepatitis B
|
0.00%
0/81 • From baseline up to 8 years
|
5.6%
1/18 • From baseline up to 8 years
|
1.0%
1/99 • From baseline up to 8 years
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/81 • From baseline up to 8 years
|
5.6%
1/18 • From baseline up to 8 years
|
1.0%
1/99 • From baseline up to 8 years
|
|
Investigations
Alanine aminotransferase increased
|
13.6%
11/81 • From baseline up to 8 years
|
16.7%
3/18 • From baseline up to 8 years
|
14.1%
14/99 • From baseline up to 8 years
|
|
Investigations
Aspartate aminotransferase increased
|
13.6%
11/81 • From baseline up to 8 years
|
27.8%
5/18 • From baseline up to 8 years
|
16.2%
16/99 • From baseline up to 8 years
|
|
Investigations
Blood albumin decreased
|
3.7%
3/81 • From baseline up to 8 years
|
5.6%
1/18 • From baseline up to 8 years
|
4.0%
4/99 • From baseline up to 8 years
|
|
Investigations
Blood alkaline phosphatase increased
|
8.6%
7/81 • From baseline up to 8 years
|
11.1%
2/18 • From baseline up to 8 years
|
9.1%
9/99 • From baseline up to 8 years
|
|
Investigations
Blood bilirubin increased
|
6.2%
5/81 • From baseline up to 8 years
|
5.6%
1/18 • From baseline up to 8 years
|
6.1%
6/99 • From baseline up to 8 years
|
|
Investigations
Blood calcium decreased
|
0.00%
0/81 • From baseline up to 8 years
|
11.1%
2/18 • From baseline up to 8 years
|
2.0%
2/99 • From baseline up to 8 years
|
|
Investigations
Blood creatinine increased
|
6.2%
5/81 • From baseline up to 8 years
|
0.00%
0/18 • From baseline up to 8 years
|
5.1%
5/99 • From baseline up to 8 years
|
|
Investigations
Blood glucose increased
|
3.7%
3/81 • From baseline up to 8 years
|
5.6%
1/18 • From baseline up to 8 years
|
4.0%
4/99 • From baseline up to 8 years
|
|
Investigations
Blood potassium decreased
|
1.2%
1/81 • From baseline up to 8 years
|
11.1%
2/18 • From baseline up to 8 years
|
3.0%
3/99 • From baseline up to 8 years
|
|
Investigations
Blood urea increased
|
0.00%
0/81 • From baseline up to 8 years
|
5.6%
1/18 • From baseline up to 8 years
|
1.0%
1/99 • From baseline up to 8 years
|
|
Investigations
Blood uric acid increased
|
0.00%
0/81 • From baseline up to 8 years
|
5.6%
1/18 • From baseline up to 8 years
|
1.0%
1/99 • From baseline up to 8 years
|
|
Investigations
Fibrin D dimer increased
|
2.5%
2/81 • From baseline up to 8 years
|
5.6%
1/18 • From baseline up to 8 years
|
3.0%
3/99 • From baseline up to 8 years
|
|
Investigations
Gamma-glutamyltransferase increased
|
8.6%
7/81 • From baseline up to 8 years
|
27.8%
5/18 • From baseline up to 8 years
|
12.1%
12/99 • From baseline up to 8 years
|
|
Investigations
Haemoglobin decreased
|
4.9%
4/81 • From baseline up to 8 years
|
16.7%
3/18 • From baseline up to 8 years
|
7.1%
7/99 • From baseline up to 8 years
|
|
Investigations
Lymphocyte count decreased
|
2.5%
2/81 • From baseline up to 8 years
|
22.2%
4/18 • From baseline up to 8 years
|
6.1%
6/99 • From baseline up to 8 years
|
|
Investigations
Neutrophil count decreased
|
30.9%
25/81 • From baseline up to 8 years
|
38.9%
7/18 • From baseline up to 8 years
|
32.3%
32/99 • From baseline up to 8 years
|
|
Investigations
Platelet count decreased
|
32.1%
26/81 • From baseline up to 8 years
|
33.3%
6/18 • From baseline up to 8 years
|
32.3%
32/99 • From baseline up to 8 years
|
|
Investigations
Protein total decreased
|
1.2%
1/81 • From baseline up to 8 years
|
5.6%
1/18 • From baseline up to 8 years
|
2.0%
2/99 • From baseline up to 8 years
|
|
Investigations
Red blood cell count decreased
|
1.2%
1/81 • From baseline up to 8 years
|
5.6%
1/18 • From baseline up to 8 years
|
2.0%
2/99 • From baseline up to 8 years
|
|
Investigations
White blood cell count decreased
|
33.3%
27/81 • From baseline up to 8 years
|
50.0%
9/18 • From baseline up to 8 years
|
36.4%
36/99 • From baseline up to 8 years
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
2.5%
2/81 • From baseline up to 8 years
|
5.6%
1/18 • From baseline up to 8 years
|
3.0%
3/99 • From baseline up to 8 years
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
4.9%
4/81 • From baseline up to 8 years
|
16.7%
3/18 • From baseline up to 8 years
|
7.1%
7/99 • From baseline up to 8 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.9%
8/81 • From baseline up to 8 years
|
5.6%
1/18 • From baseline up to 8 years
|
9.1%
9/99 • From baseline up to 8 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.2%
5/81 • From baseline up to 8 years
|
5.6%
1/18 • From baseline up to 8 years
|
6.1%
6/99 • From baseline up to 8 years
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
2.5%
2/81 • From baseline up to 8 years
|
5.6%
1/18 • From baseline up to 8 years
|
3.0%
3/99 • From baseline up to 8 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/81 • From baseline up to 8 years
|
5.6%
1/18 • From baseline up to 8 years
|
1.0%
1/99 • From baseline up to 8 years
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/81 • From baseline up to 8 years
|
5.6%
1/18 • From baseline up to 8 years
|
1.0%
1/99 • From baseline up to 8 years
|
|
Renal and urinary disorders
Proteinuria
|
12.3%
10/81 • From baseline up to 8 years
|
0.00%
0/18 • From baseline up to 8 years
|
10.1%
10/99 • From baseline up to 8 years
|
|
Reproductive system and breast disorders
Pelvic fluid collection
|
0.00%
0/81 • From baseline up to 8 years
|
5.6%
1/18 • From baseline up to 8 years
|
1.0%
1/99 • From baseline up to 8 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/81 • From baseline up to 8 years
|
5.6%
1/18 • From baseline up to 8 years
|
1.0%
1/99 • From baseline up to 8 years
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/81 • From baseline up to 8 years
|
5.6%
1/18 • From baseline up to 8 years
|
1.0%
1/99 • From baseline up to 8 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
8.6%
7/81 • From baseline up to 8 years
|
5.6%
1/18 • From baseline up to 8 years
|
8.1%
8/99 • From baseline up to 8 years
|
|
Surgical and medical procedures
Portal vein embolisation
|
0.00%
0/81 • From baseline up to 8 years
|
5.6%
1/18 • From baseline up to 8 years
|
1.0%
1/99 • From baseline up to 8 years
|
|
Vascular disorders
Hypertension
|
9.9%
8/81 • From baseline up to 8 years
|
5.6%
1/18 • From baseline up to 8 years
|
9.1%
9/99 • From baseline up to 8 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER