You are here

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

Last updated on December 6, 2018

FOR MORE INFORMATION
Study Location
Oncology Department, The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230061 China
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pancreatic Neuroendocrine Tumors
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT02282059
Pfizer
Recruiting
The Safety And Efficacy Of Sunitinib In Chinese Patients With Progressive Advanced Or Metastatic Well-Differentiated Unresectable Pancreatic Neuroendocrine Tumors

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Pancreatic Cancer, Non-Small Cell Lung Cancer, Cancer
NCT03637491
All Genders
18+
Years
Multiple Sites
Solid Tumors, Ewing Sarcoma, Rhabdoid Tumor, Rhabdomyosarcoma, Neuroblastoma, Medulloblastoma
NCT03709680
All Genders
Locally Advanced or Metastatic Solid Tumors, BRCA 1 Genes
NCT03565991
All Genders
18+
Years
Multiple Sites
Avelumab in Combination With Talazoparib Will be Investigated in Patients With Locally Advanced (Primary or Recurrent) or Metastatic Solid Tumors
NCT03330405
All Genders
18+
Years
Multiple Sites
The Safety And Efficacy Of Sunitinib In Chinese Patients With Progressive Advanced Or Metastatic Well-Differentiated Unresectable Pancreatic Neuroendocrine Tumors
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.
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
Observational
Observational Model: Other
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
The Chinese adult with progressive advanced or metastatic well-differentiated unresectable pancreatic neuroendocrine tumors is the target population.
Pancreatic Neuroendocrine Tumors
Drug: sunitinib
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
sunitinib group
patients with progressive, unresectable, advanced or metastatic well-differentiated pNET
Intervention: Drug: sunitinib
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2022
December 2022   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
China
 
 
NCT02282059
A6181215
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now