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OPALINE : A Study Of Morbidity And Mortality At 2 Years

Last updated on December 6, 2019

FOR MORE INFORMATION
Study Location
CHU d'Amiens
Amiens, , 80054 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
OPALINE : A Study Of Morbidity And Mortality At 2 Years

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Well Differentiated and Progressive Pancreatic Neuroendocrine Tumor
NCT02264665
All Genders
18+
Years
Multiple Sites
Descriptive Information
Brief Title OPALINE : A Study Of Morbidity And Mortality At 2 Years
Official Title AN OBSERVATIONAL REAL-WORLD STUDY OF THE SYSTEMIC TREATMENT OF WELL-DIFFERENTIATED, UNRESECTABLE OR METASTATIC, PROGRESSIVE PANCREATIC NEUROENDOCRINE TUMOURS (PNET): A STUDY OF MORBIDITY AND MORTALITY AT 2 YEARS
Brief Summary 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.
Detailed Description prospective and retrospective Analyses will be performed using SAS® software
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with progressive, metastatic or unresectable, and well differentiated pancreatic neuroendocrine tumors
Condition Pancreatic Neuroendocrine Tumor, Well Differentiated and Progressive
Intervention
  • Drug: sunitinib
    sunitinib 37.5mg/d orally
  • Drug: everolimus
    everolimus 10mg/d orally
  • Drug: chemotherapies recommended in france
    depends on the chemotherapy prescribed (IV)
Study Groups/Cohorts
  • Sunitinib
    Intervention: Drug: sunitinib
  • Afinitor
    Intervention: Drug: everolimus
  • other treatment (chémotherapy, SSA..)
    Intervention: Drug: chemotherapies recommended in france
Publications * Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 5, 2016)
150
Original Estimated Enrollment
 (submitted: October 9, 2014)
170
Estimated Study Completion Date October 20, 2019
Estimated Primary Completion Date October 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02264665
Other Study ID Numbers A6181214
OPALINE ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: 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/da....
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators
  • Novartis
  • Keyrus Biopharma
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2019

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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