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Trial record 1 of 1 for:    NCT02264665
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OPALINE : A Study Of Morbidity And Mortality At 2 Years (OPALINE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02264665
Recruitment Status : Completed
First Posted : October 15, 2014
Last Update Posted : January 2, 2020
Sponsor:
Collaborators:
Novartis
Keyrus Biopharma
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date September 2, 2014
First Posted Date October 15, 2014
Last Update Posted Date January 2, 2020
Actual Study Start Date May 12, 2015
Actual Primary Completion Date November 18, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 14, 2018)
  • progression-free survival [ Time Frame: at baseline, each 3 to 4 months up to 2 years ]
  • Overall survival [ Time Frame: at baseline, each 3 to 4 months up to 2 years ]
  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: at baseline, each 3 to 4 months up to 2 years ]
Original Primary Outcome Measures
 (submitted: October 9, 2014)
Progression-Free Survival (PFS) [ Time Frame: at baseline, each 3 to 4 months up to 2 years ]
Median time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. PFS calculated as (Weeks) = (first event date minus first dose date plus 1) divided by 7
Change History
Current Secondary Outcome Measures
 (submitted: December 14, 2018)
  • Patient demographic characteristics [ Time Frame: baseline ]
  • number of subjects using targeted therapy at baseline [ Time Frame: Baseline ]
  • Change from baseline in treatment therapy received [ Time Frame: approximately every 3 months up to 2 years ]
  • number of subjects using therapy other than targeted at baseline [ Time Frame: Baseline ]
Original Secondary Outcome Measures
 (submitted: October 9, 2014)
Overall Survival (OS) [ Time Frame: baseline, each visit up to 2 years ]
Overall survival was the duration from enrollment to death. For participants who are alive, overall survival was censored at the last contact.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Completed
Actual Enrollment
 (submitted: December 30, 2019)
147
Original Estimated Enrollment
 (submitted: October 9, 2014)
170
Actual Study Completion Date November 18, 2019
Actual Primary Completion Date November 18, 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 information is only displayed when the study is recruiting subjects
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/data_requests.
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators
  • Novartis
  • Keyrus Biopharma
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date December 2019