Pancreatic Neuroendocrine TumorsNCT02282059

The Safety And Efficacy Of Sunitinib In Chinese Patients With Progressive Advanced Or Metastatic Well-Differentiated Unresectable Pancreatic Neuroendocrine Tumors

An observational study of Pancreatic Neuroendocrine Tumors, run by Pfizer at 24 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Pancreatic Neuroendocrine Tumors
What is being tested?: sunitinib
Type of treatment: Pill or oral medicine
How many people: 100 participants
Where: 24 sitesChina
Study dates: 12 Dec 2014to 12 Dec 2022
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: The Chinese adult with progressive advanced or metastatic well-differentiated unresectable pancreatic neuroendocrine tumors is the target population.

Who may be able to join

Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Subjects who are willing to follow up visits within current clinical practice.
Histologically or cytologically proven diagnosis of well-differentiated pancreatic neuroendocrine tumors (according to WHO 2000 classification)
Unresectable (as assessed by the investigator) or metastatic disease documented on a scan
A minimum age of 18 years

Who cannot join

Patients with poorly-differentiated pancreatic neuroendocrine tumors (according to WHO 2000 classification)
Patients who have received at least one dosage of sunitinib treatment prior to signing informed consent form will be excluded from participating in this study.

Trial locations and contacts

24 sites in 1 country.

City, postcode or hospital

24 sites in 1 country

China24 sites

Department of Medical Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Fifth Medical Center of PLA General Hospital
Beijing, 100071
The PLA of 307 Hospital
Beijing, 100071
West China Hospital of Sichuan University/Hepatobiliary Pancreatic Surgery
Chengdu, Sichuan, 610041
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
SUN Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060
The Affiliated Tumour Hospital of Harbin Medical University
Haerbin, Heilongjiang, 150081
Zhejiang Cancer Hospital, Oncology department
Hangzhou, Zhejiang, 310022
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Oncology Department, The Second Affiliated Hospital of Anhui Medical University
Hefei, An'hui, 230061
Eastern Theater General Hospital,QinHuai District Medical Area
Nanjing, Jiangsu, 210002
General Hospital of Eastern Theater Command
Nanjing, Jiangsu, 210002
Nanjing Bayi Hospital
Nanjing, Jiangsu, 210002
Nanjing General Hospital of Nanjing Military Command/Hepatobiliary Surgery Department
Nanjing, Jiangsu, 210002
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Fudan University Shanghai Cancer Center
Shanghai, 200032
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300060
Tianjin Medical University General Hospital/General Surgery
Tianjin, 300052
Tianjin Medical University General Hospital
Tianjin, 300052
Digestive surgery Department, The First Affiliated Hospital, The Fourth Military Medical University
Xi'an, Shannxi, 710032
The First Affiliated Hospital，Air Force Medical University
Xi'an, Shannxi, 710032
Air Force Medical University
Xi’an, Shanxi
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052

Other trials in China

About this study

Official title: A Multi Center, Prospective, Non Interventional (NI) Study of the Safety and Efficacy of Sunitinib in Chinese Patients With Progressive Advanced or Metastatic Well Differentiated Unresectable Pancreatic Neuroendocrine Tumors

This study is a multi-center, prospective, non-interventional (NI) study evaluating the safety and efficacy of sunitinib in Chinese patients with progressive, unresectable, advanced or metastatic well-differentiated, pancreatic neuroendocrine tumors(pNET). 100 adults with progressive advanced or metastatic well-differentiated unresectable pNET will be recruited in China hospitals. Each subject will be followed up overall survival (OS) time or the date of withdrawal and subjects who remain alive after study completion will have their OS time censored on the last date known to be alive. Eligible subjects will be enrolled to receive at least one dose of sunitinib orally at 37.5 mg once a day on a continuous daily dosing regimen (CDD) or dosage modification is based on daily clinic practice. Subjects will be treated until disease progress, unacceptable toxicity, withdrawal from the study at their own request, or until the final analysis for the study is performed. The NI study will capture observations that will be used for evaluating the safety profile of sunitinib, including: subject demographics, medical history and medications. Safety assessments, treatment data and any other laboratory examination results, which were done according to routine clinical practice, will be collected at all visits.

Read the detailed description

The sunitinib non-interventional (NI) study is a real world observational study which represents the usual and customary treatment of patients and being proposed to collect data systematically and to assess the safety and efficacy in Chinese patients with progressive, unresectable, advanced or metastatic well-differentiated, pancreatic neuroendocrine tumors.It is designed and conducted to meet CFDA post-marketing commitments. non-probability sample

Conditions: Pancreatic Neuroendocrine Tumors
Being tested: sunitinib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

sunitinibDrug
subjects will be enrolled to receive at least one dose of sunitinib orally at 37.5 mg once a day on a continuous daily dosing regimen (CDD) or dosage modification is based on daily clinic practice

Study groups in NCT02282059
Study group	Role	What they receive
sunitinib group		patients with progressive, unresectable, advanced or metastatic well-differentiated pNET Receives: Drug: sunitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causalities and Treatment-related)
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.
Measured: From baseline up to 8 years
Number of Participants With Serious Adverse Events (SAEs) (All Causalities and Treatment-related)
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.
Measured: From baseline up to 8 years
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
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.
Measured: From baseline up to 8 years

Secondary outcomes (4)

Progression-Free Survival (PFS)
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.
Measured: From baseline up to 8 years
Progression-Free Survival by Clinical Judgment
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.
Measured: From baseline up to 8 years
Overall Survival (OS)
OS was defined as the time from the start of sunitinib treatment to documentation of death due to any cause.
Measured: From baseline up to 8 years
Five-Year Survival Rate
Five-year survival rate was defined as the proportion of participants who stayed alive till after 5 years from the start of sunitinib treatment.
Measured: From baseline up to 8 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Dec 201412 Dec 2022

First posted4 Nov 2014 (estimated)
Study start12 Dec 2014
Primary completion12 Dec 2022
Study completion12 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pancreatic Neuroendocrine TumorsStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02282059
Sponsor's protocol ID: A6181215
Status last verified: Jun 2024
First submitted: 15 Oct 2014
Last updated: 20 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pancreatic Neuroendocrine Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi Center, Prospective, Non Interventional (NI) Study of the Safety and Efficacy of Sunitinib in Chinese Patients With Progressive Advanced or Metastatic Well Differentiated Unresectable Pancreatic Neuroendocrine Tumors
ClinicalTrials.gov ID: NCT02282059
Acronym / sponsor ID: A6181215
Conditions: Pancreatic Neuroendocrine Tumors
Study type: Observational
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 12 Dec 2014 (actual)
Primary completion: 12 Dec 2022 (actual)
Study completion: 12 Dec 2022 (actual)
First posted: 4 Nov 2014 (estimated)
Results: Posted 20 Jun 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Other
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
sunitinib group	–	Drug: sunitinibpatients with progressive, unresectable, advanced or metastatic well-differentiated pNET

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The Chinese adult with progressive advanced or metastatic well-differentiated unresectable pancreatic neuroendocrine tumors is the target population.

Key inclusion criteria (5 listed)

Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Subjects who are willing to follow up visits within current clinical practice.
Histologically or cytologically proven diagnosis of well-differentiated pancreatic neuroendocrine tumors (according to WHO 2000 classification)
Unresectable (as assessed by the investigator) or metastatic disease documented on a scan
A minimum age of 18 years

Key exclusion criteria (2 listed)

Patients with poorly-differentiated pancreatic neuroendocrine tumors (according to WHO 2000 classification)
Patients who have received at least one dosage of sunitinib treatment prior to signing informed consent form will be excluded from participating in this study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
sunitinibsubjects will be enrolled to receive at least one dose of sunitinib orally at 37.5 mg once a day on a continuous daily dosing regimen (CDD) or dosage modification is based on daily clinic practice	Drug	sunitinib group

Primary outcome

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causalities and Treatment-related)
Time frame: 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.
Number of Participants With Serious Adverse Events (SAEs) (All Causalities and Treatment-related)
Time frame: 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.
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
Time frame: 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.

4 secondary outcomes

Progression-Free Survival (PFS)
Time frame: From baseline up to 8 years
Progression-Free Survival by Clinical Judgment
Time frame: From baseline up to 8 years
Overall Survival (OS)
Time frame: From baseline up to 8 years
Five-Year Survival Rate
Time frame: From baseline up to 8 years

Results and safety

Results posted to the registry on 20 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sunitinib (Not Taken)	82	0
Sunitinib (Already Taken)	18	0

Primary outcome: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causalities and Treatment-related)

Time frame: From baseline up to 8 years. Count of participants. Unit: Participants

Measure	Sunitinib (Not Taken) n = 81	Sunitinib (Already Taken) n = 18
All-causality TEAEs	61	13
Treatment-related TEAEs	52	12

Population analysed: The safety analysis population included all enrolled participants who took at least 1 dose of the study drug.

Primary outcome: Number of Participants With Serious Adverse Events (SAEs) (All Causalities and Treatment-related)

Time frame: From baseline up to 8 years. Count of participants. Unit: Participants

Measure	Sunitinib (Not Taken) n = 81	Sunitinib (Already Taken) n = 18
All-causality SAEs	11	5
Treatment-related SAEs	2	2

Population analysed: The safety analysis population included all enrolled participants who took at least 1 dose of the study drug.

Primary outcome: 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

Time frame: From baseline up to 8 years. Count of participants. Unit: Participants

Measure	Sunitinib (Not Taken) n = 81	Sunitinib (Already Taken) n = 18
Anemia (Grade 0 to Grade 3)	2	2
Anemia (Grade 1 to Grade 3)	1	1
Anemia (Grade 2 to Grade 3)	4	1
Lymphocyte count decreased (Grade 0 to Grade 3)	4	1
Lymphocyte count decreased (Grade 1 to Grade 3)	1	0
Lymphocyte count decreased (Grade 2 to Grade 3)	1	0
Neutrophil count decreased (Grade 0 to Grade 3)	7	3
Neutrophil count decreased (Grade 1 to Grade 3)	1	1

Population analysed: 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.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From baseline up to 8 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sunitinib (Not Taken)	11 of 81 (13.6%)	55 of 81 (67.9%)	40 of 81
Sunitinib (Already Taken)	5 of 18 (27.8%)	13 of 18 (72.2%)	8 of 18
Total	16 of 99 (16.2%)	68 of 99 (68.7%)	48 of 99

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

24 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Pancreatic Neuroendocrine Tumors, run by Pfizer at 24 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causalities and Treatment-related) (time frame: From baseline up to 8 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02282059.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.