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OPALINE : A Study Of Morbidity And Mortality At 2 Years

Last updated on March 4, 2019

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.
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- 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.
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- 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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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]

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Well Differentiated and Progressive Pancreatic Neuroendocrine Tumor
NCT02264665
All Genders
18+
Years
Multiple Sites

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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