You are here

Observational Study In Real Life Settings Of The Systemic Treatment Of Well Differentiated, Unresectable Or Metastatic, Progressive Pancreatic Neuroendocrine Tumors (pNET): A Study Of Morbidity And Mortality At 2 Years

Last updated on October 4, 2018

FOR MORE INFORMATION
Study Location
Ch du Pays D Aix
Aix en Provence Cedex 1, , 13616 France
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Well Differentiated and Progressive Pancreatic Neuroendocrine Tumor
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-99 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients over 18 years of age;

- Patients treated with a targeted therapy (sunitinib, everolimus) or with other
treatments (interferon, or metabolic radiotherapy, or chemotherapy or somatostatin
analog)* for:

*Patients whose treatment line (targeted therapy or other treatment) is initiated as a
1st, 2nd, 3rd or 4th line of therapy at the time of inclusion (incident patients) or
patients receiving their 1st, 2nd, 3rd or 4th line of therapy provided that treatment
was initiated in the site in which the patient is enrolled in the study (prevalent
patients); a change of line is defined as a change in molecule or combination.

- A histologically confirmed unresectable or metastatic pancreatic neuroendocrine tumor;

- Well‐differentiated;

- Progressive prior to initiation of treatment in the investigator's judgment (clinical
or radiological progression);

- Patients who have been informed of the conditions of the study and who have signed the
informed consent.

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

- Patients with a diagnosis of poorly differentiated neuroendocrine carcinoma or an
adenoneuroendocrine carcinoma.

- Patients receiving targeted therapy (everolimus or sunitinib) already received in a
previous line of treatment (rechallenged patient).

- Patients refusing to give consent.

- Patients receiving a fifth line or subsequent line of systemic treatment.

- Patients participating in a clinical trial in a treatment arm not validated by the MA
and the TNCD according to the version dated December 2013.

- Patients randomized to the placebo arm of a placebo?controlled trial or to a
double?blind trial.

NCT02264665
Pfizer
Recruiting
Observational Study In Real Life Settings Of The Systemic Treatment Of Well Differentiated, Unresectable Or Metastatic, Progressive Pancreatic Neuroendocrine Tumors (pNET): A Study Of Morbidity And Mortality At 2 Years

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

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
Non-Hodgkin Lymphoma, Follicular Lymphoma, Large B-Cell Lymphoma, Non-Small-Cell Lung Carcinoma, Renal Cell Carcinoma, Squamous Cell of Head and Neck Carcinoma, Malignant Melanoma
NCT01307267
All Genders
18+
Years
Multiple Sites
Observational Study In Real Life Settings Of The Systemic Treatment Of Well Differentiated, Unresectable Or Metastatic, Progressive Pancreatic Neuroendocrine Tumors (pNET): A Study Of Morbidity And Mortality At 2 Years
Observational Study In Real Life Settings Of The Systemic Treatment Of Well Differentiated, Unresectable Or Metastatic, Progressive Pancreatic Neuroendocrine Tumors (Pnet): A Study Of Morbidity And Mortality At 2 Years
A descriptive, prospective (partly retrospective), multisite, observational study conducted in France in adult patients treated for a well differentiated, unresectable or metastatic, pancreatic neuroendocrine tumor with disease progression.
prospective and retrospective Analyses will be performed using SAS® software
Observational
Observational Model: Cohort
Time Perspective: Other
Not Provided
Not Provided
Non-Probability Sample
patients with progressive and metastatic pancreatic neuroendocrin tumors
Pancreatic Neuroendocrine Tumor, Well Differentiated and Progressive
  • Drug: sunitinib
    sunitinib 37.5mg/d orally
  • Drug: everolimus
    everolimus 10mg/d orally
  • Drug: chemotherapies recommended in france
    depends on the chemotherapy prescribed (IV)
  • Sunitinib
    Intervention: Drug: sunitinib
  • Afinitor
    Intervention: Drug: everolimus
  • other treatment (chémotherapy, SSA..)
    Intervention: Drug: chemotherapies recommended in france
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
June 5, 2019
June 5, 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients over 18 years of age;
  • Patients treated with a targeted therapy (sunitinib, everolimus) or with other treatments (interferon, or metabolic radiotherapy, or chemotherapy or somatostatin analog)* for:

    *Patients whose treatment line (targeted therapy or other treatment) is initiated as a 1st, 2nd, 3rd or 4th line of therapy at the time of inclusion (incident patients) or patients receiving their 1st, 2nd, 3rd or 4th line of therapy provided that treatment was initiated in the site in which the patient is enrolled in the study (prevalent patients); a change of line is defined as a change in molecule or combination.

  • A histologically confirmed unresectable or metastatic pancreatic neuroendocrine tumor;
  • Well?differentiated;
  • Progressive prior to initiation of treatment in the investigator's judgment (clinical or radiological progression);
  • Patients who have been informed of the conditions of the study and who have signed the informed consent.

Exclusion Criteria:

  • Patients with a diagnosis of poorly differentiated neuroendocrine carcinoma or an adenoneuroendocrine carcinoma.
  • Patients receiving targeted therapy (everolimus or sunitinib) already received in a previous line of treatment (rechallenged patient).
  • Patients refusing to give consent.
  • Patients receiving a fifth line or subsequent line of systemic treatment.
  • Patients participating in a clinical trial in a treatment arm not validated by the MA and the TNCD according to the version dated December 2013.
  • Patients randomized to the placebo arm of a placebo?controlled trial or to a double?blind trial.
Sexes Eligible for Study: All
18 Years to 99 Years   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
France
 
 
NCT02264665
A6181214
OPALINE ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
  • Novartis
  • Keyrus Biopharma
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 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