Trial · NCT02282059
The Safety And Efficacy Of Sunitinib In Chinese Patients With Progressive Advanced Or Metastatic Well-Differentiated Unresectable Pancreatic Neuroendocrine Tumors
NCT02282059, Completed, Pfizer; results first posted 2024-06-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. The Safety And Efficacy Of Sunitinib In Chinese Patients With Progressive Advanced Or Metastatic Well-Differentiated Unresectable Pancreatic Neuroendocrine Tumors. Trials, record NCT02282059. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02282059
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Safety And Efficacy Of Sunitinib In Chinese Patients With Progressive Advanced Or Metastatic Well-Differentiated Unresectable Pancreatic Neuroendocrine Tumors
- NCT number
- NCT02282059
- Status
- Completed
- Enrollment
- 100 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Pancreatic Neuroendocrine Tumors
- Interventions
- sunitinib
- First posted
- 2014-11-04
- Last updated
- 2024-06-20
- Results first posted
- 2024-06-20
- Limitations and caveats
Due to the real world nature of this study, heterogeneity of clinical judgment and clinical practice may exist which may include but it not limited to the following: timing of imaging/laboratory testing, different measurement techniques/standards for judging tumor change.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causalities and Treatment-related) | From baseline up to 8 years | 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. |
| Primary | Number of Participants With Serious Adverse Events (SAEs) (All Causalities and Treatment-related) | From baseline up to 8 years | 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. |
| Primary | 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 | From baseline up to 8 years | 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. |
| Secondary | Progression-Free Survival (PFS) | From baseline up to 8 years | 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. |
| Secondary | Progression-Free Survival by Clinical Judgment | From baseline up to 8 years | 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. |
| Secondary | Overall Survival (OS) | From baseline up to 8 years | OS was defined as the time from the start of sunitinib treatment to documentation of death due to any cause. |
| Secondary | Five-Year Survival Rate | From baseline up to 8 years | Five-year survival rate was defined as the proportion of participants who stayed alive till after 5 years from the start of sunitinib treatment. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causalities and Treatment-related) | From baseline up to 8 years | The safety analysis population included all enrolled participants who took at least 1 dose of the study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Serious Adverse Events (SAEs) (All Causalities and Treatment-related) | From baseline up to 8 years | The safety analysis population included all enrolled participants who took at least 1 dose of the study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | 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 | From baseline up to 8 years | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-Free Survival (PFS) | From baseline up to 8 years | The analysis population included all participants who took at least 1 dose of the study drug. | Months | MEDIAN |
| SECONDARY | Progression-Free Survival by Clinical Judgment | From baseline up to 8 years | The analysis population included all participants who took at least 1 dose of the study drug. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From baseline up to 8 years | The analysis population included all participants who took at least 1 dose of the study drug. | Months | MEDIAN |
| SECONDARY | Five-Year Survival Rate | From baseline up to 8 years | The analysis population included all participants who took at least 1 dose of the study drug. | Proportion of participants | NUMBER |
Source ClinicalTrials.gov
Results by group86
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causalities and Treatment-related) | Sunitinib (Not Taken) | All-causality TEAEs | 61 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causalities and Treatment-related) | Sunitinib (Already Taken) | All-causality TEAEs | 13 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causalities and Treatment-related) | Sunitinib (Not Taken) | Treatment-related TEAEs | 52 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causalities and Treatment-related) | Sunitinib (Already Taken) | Treatment-related TEAEs | 12 | Participants | |
| Number of Participants With Serious Adverse Events (SAEs) (All Causalities and Treatment-related) | Sunitinib (Not Taken) | All-causality SAEs | 11 | Participants | |
| Number of Participants With Serious Adverse Events (SAEs) (All Causalities and Treatment-related) | Sunitinib (Already Taken) | All-causality SAEs | 5 | Participants | |
| Number of Participants With Serious Adverse Events (SAEs) (All Causalities and Treatment-related) | Sunitinib (Not Taken) | Treatment-related SAEs | 2 | Participants | |
| Number of Participants With Serious Adverse Events (SAEs) (All Causalities and Treatment-related) | Sunitinib (Already Taken) | Treatment-related SAEs | 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 | Sunitinib (Not Taken) | Anemia (Grade 0 to Grade 3) | 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 | Sunitinib (Already Taken) | Anemia (Grade 0 to Grade 3) | 2 | Participants |
1 to 10 of 86Source ClinicalTrials.gov
See all 86 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sunitinib (Not Taken) | 82 | |
| Overall Study | STARTED | Sunitinib (Already Taken) | 18 | |
| Overall Study | Treated | Sunitinib (Not Taken) | 81 | |
| Overall Study | Treated | Sunitinib (Already Taken) | 18 | |
| Overall Study | Discontinued | Sunitinib (Not Taken) | 82 | |
| Overall Study | Discontinued | Sunitinib (Already Taken) | 18 | |
| Overall Study | COMPLETED | Sunitinib (Not Taken) | 0 | |
| Overall Study | COMPLETED | Sunitinib (Already Taken) | 0 | |
| Overall Study | NOT COMPLETED | Sunitinib (Not Taken) | 82 | |
| Overall Study | NOT COMPLETED | Sunitinib (Already Taken) | 18 |
Source ClinicalTrials.gov
Adverse events222
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Sunitinib (Not Taken) | 19 | 81 | |
| other | Anaemia | Blood and lymphatic system disorders | Sunitinib (Already Taken) | 6 | 18 | |
| other | Anaemia | Blood and lymphatic system disorders | Total | 25 | 99 | |
| other | Myelosuppression | Blood and lymphatic system disorders | Sunitinib (Not Taken) | 3 | 81 | |
| other | Myelosuppression | Blood and lymphatic system disorders | Sunitinib (Already Taken) | 1 | 18 | |
| other | Myelosuppression | Blood and lymphatic system disorders | Total | 4 | 99 | |
| other | Neutropenia | Blood and lymphatic system disorders | Sunitinib (Not Taken) | 7 | 81 | |
| other | Neutropenia | Blood and lymphatic system disorders | Sunitinib (Already Taken) | 5 | 18 | |
| other | Neutropenia | Blood and lymphatic system disorders | Total | 12 | 99 | |
| other | Eyelid oedema | Eye disorders | Sunitinib (Not Taken) | 1 | 81 |
1 to 10 of 222Source ClinicalTrials.gov
See all 222 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sunitinib (Not Taken) | 40 | 81 |
| Total, all-cause mortality | Sunitinib (Already Taken) | 8 | 18 |
| Total, all-cause mortality | Total | 48 | 99 |
| Total, other adverse events | Sunitinib (Not Taken) | 55 | 81 |
| Total, other adverse events | Sunitinib (Already Taken) | 13 | 18 |
| Total, other adverse events | Total | 68 | 99 |
| Total, serious adverse events | Sunitinib (Not Taken) | 11 | 81 |
| Total, serious adverse events | Sunitinib (Already Taken) | 5 | 18 |
| Total, serious adverse events | Total | 16 | 99 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02282059
GET https://conductscience.org/api/trials/v1/NCT02282059/results?page=2