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Trial record 1 of 1 for:    NCT02454530
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Use of Biosimilar Nivestim® to Prevent Chemo-induced Neutropenia. Real Life Study (VISTA)

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ClinicalTrials.gov Identifier: NCT02454530
Recruitment Status : Terminated (The study was stopped due to the judicial liquidation of the CRO in charge of this study.)
First Posted : May 27, 2015
Results First Posted : June 28, 2019
Last Update Posted : June 28, 2019
Sponsor:
Collaborator:
Hospira, now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date May 22, 2015
First Posted Date May 27, 2015
Results First Submitted Date November 9, 2018
Results First Posted Date June 28, 2019
Last Update Posted Date June 28, 2019
Actual Study Start Date September 2014
Actual Primary Completion Date October 18, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 29, 2019)
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim [ Time Frame: Inclusion visit (Week 1) ]
The factors which determined the use of Nivestim among participants included participant's sex, young participant, elderly participant, past history of infection, comorbidities, life expectancy, past history of febrile neutropenia and severe neutropenia, occupational activity, family activity and other important criteria. Percentage of participants were categorized based upon the level of importance under different categories which included very important, important, relatively important, not important and not applicable.
Original Primary Outcome Measures
 (submitted: May 26, 2015)
Patterns of use of prophylactic NivestimTM for chemo-induced neutropenia. [ Time Frame: End of the baseline visit (Patients are included at the time of the Nivestim® prescription prior to their chemotherapy) ]
The patterns of use of NivestimTM will be described, globally and by subgroups (adjuvant and metastatic setting). It will be assessed from the profile of patients (infectious history, stage of the disease ...) and the oncologist motivations at initiation of prophylactic NivestimTM treatment.
Change History Complete list of historical versions of study NCT02454530 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 29, 2019)
  • Number of Participants Who Continued Chemotherapy [ Time Frame: Follow-up visit (Week 3); End of study visit ( up to Week 19) ]
    Chemotherapy is a type of cancer treatment that uses one or more anti-cancer drugs as a part of a standardize treatment regimen. Chemotherapy may be given with curative intent, or it may aim to prolong life or to reduce symptoms.
  • Number of Participants Who Discontinued Chemotherapy [ Time Frame: Follow-up visit (Week 3); End of study visit ( up to Week 19) ]
  • Number of Participants With Unplanned Discontinuation of Chemotherapy at Follow Up Visit [ Time Frame: Follow-up visit (Week 3) ]
  • Number of Participants With Dose Reduction in Chemotherapy Due to Neutropenia [ Time Frame: Follow-up visit (Week 3) ]
    Neutropenia is an abnormally low level of neutrophils (count of less than 1,500 neutrophils per microliter (microL) in blood) and was classified as Grade 1 (mild) with an absolute neutrophil count (ANC) of 1000-1500 cells per microL, Grade 2 (moderate) with an ANC of 500-1000 cells per microL, or Grade 3 (severe) with an ANC lower than 500 cells per microL.
  • Number of Participants With Delayed Administration of Chemotherapy Cycle Due to Neutropenia [ Time Frame: Follow-up visit (Week 3) ]
    Neutropenia is an abnormally low level of neutrophils (count of less than 1,500 neutrophils per microliter (microL) in blood) and was classified as Grade 1 (mild) with an absolute neutrophil count (ANC) of 1000-1500 cells per microL, Grade 2 (moderate) with an ANC of 500-1000 cells per microL, or Grade 3 (severe) with an ANC lower than 500 cells per microL.
  • Number of Participants With Unplanned Discontinuation of Chemotherapy at the End of Study Visit [ Time Frame: End of study visit (up to Week 19) ]
    The reasons for unplanned discontinuation of chemotherapy included neutropenia, febrile neutropenia, other toxicity, development of resistance to treatment and other. Also, one participant could have more than one reason for unplanned discontinuation.
  • Number of Participants With Change in Chemotherapy Protocol at End of Study Visit [ Time Frame: End of study visit (up to Week 19) ]
    Number of participants with change in chemotherapy protocol due to each conditions (neutropenia, febrile neutropenia, neutropenia/febrile neutropenia, other toxicity, neutropenia/other toxicity) has been reported in this outcome measure.
  • Number of Participants With Neutropenia and Febrile Neutropenia [ Time Frame: Follow-up visit (Week 3); End of study visit (up to Week 19) ]
    Neutropenia is an abnormally low level of neutrophils (count of less than 1,500 neutrophils per microL in blood) and was classified as Grade 1 (mild) with an ANC of 1000-1500 cells per microL, Grade 2 (moderate) with an ANC of 500-1000 cells per microL, or Grade 3 (severe) with an ANC lower than 500 cells per microL. The incidence of neutropenia (between follow up and final visit) were described from the questionnaire completed by the investigator during the final visit. Febrile neutropenia was defined as tympanic or axillary body temperature greater than (>) 38.5 degree celsius for >1 hour and ANC less than (<) 1.0 *10^9 neutrophils per liter. The incidence of febrile neutropenia were described from the questionnaire completed by the investigator during the follow-up and final visits. Only those categories which had atleast 1 abnormality have been reported in this outcome measure.
  • Change From Inclusion Visit in Disease Status as Measured by Number of Neutrophil Cells (Neutrophils), Platelet Count and Leukocyte Count at End of Study [ Time Frame: Inclusion visit (Week 1), End of study visit (up to Week 19) ]
    Change in the disease status of the participant was measured by the change in the count of neutrophils (NPs), platelets and leukocytes as reported in this outcome measure.
  • Change From Inclusion Visit in Disease Status as Measured by Participants Performance Status at End of Study [ Time Frame: Inclusion visit (Week 1); End of study visit (up to Week 19) ]
    The Karnofsky performance scale was used for rating participant activities of daily living. The KPS scores range from 0 to 100. A higher score means the participant is better able to carry out daily activities. The lower the Karnofsky score, the worse the survival for most serious illnesses. The score ranges included as 100 (Normal; no complaints), 90 (Able to carry on normal activity), 80 (Normal activity with effort), 70 (Cares for self; unable to carry on normal activity), 60 (Requires occasional assistance, but is able to care), 50 (Requires considerable assistance and frequent medical care), 40 (Disabled; requires special care), 30 (Severely disabled), 20 (Very sick; hospital admission necessary), 10 (Moribund; fatal processes progressing rapidly) and 0 (Dead).
  • Change From Inclusion Visit in Disease Status as Measured by Haemoglobin Level at End of Study Visit [ Time Frame: Inclusion visit (Week 1), End of study visit (up to Week 19) ]
    Change in the disease status of the participant was measured by the change in the hemoglobin level as reported in this outcome measure.
  • Pain Experienced by Participant During Injection of Nivestim as Assessed by Pain at the Injection Site [ Time Frame: End of study visit (up to Week 19) ]
    Pain experienced by participant at the injection site was measured on a scale 0 to 10 (0 = no pain to 10 = maximum pain), where higher score indicates maximum pain.
  • Number of Participants With Chemotherapy Satisfaction as Per Doctor Assessment After Chemotherapy Treatment [ Time Frame: End of study visit (up to Week 19) ]
    Participant's satisfaction after the chemotherapy treatment was assessed by the doctor and was categorized under the 4 categories as very satisfied, satisfied, not very satisfied and dissatisfied.
  • Number of Participants Who Wished to Again Have Nivestim Treatment If Necessary [ Time Frame: End of study visit (up to Week 19) ]
  • Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: Inclusion visit (Week 1) up to end of study visit (up to Week 19) ]
    An adverse event (AE) was any untoward medical occurrence in participants who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment Emergent Adverse Event (TEAE) was adverse event that started or worsened in severity after Inclusion visit up to end of study visit (up to Week 19). AEs included both serious and non-serious adverse event. If a participant who reported an SAE also reported an AE that was not serious, that would count as 1 participant in the total number of participants reporting AEs.
Original Secondary Outcome Measures
 (submitted: May 26, 2015)
Tolerance to treatment with NivestimTM [ Time Frame: Each patient will be followed up to maximum 16-18 weeks after baseline visit or after the last cycle of chemotherapy ]
The safety will be assessed by the record of adverse effects (serious or not) and treatment discontinuation.
Current Other Pre-specified Outcome Measures
 (submitted: March 29, 2019)
Number of Participants in Different Profiles Receiving Treatment With Nivestim [ Time Frame: End of study visit (up to Week 19) ]
Classification of participants into three different profiles were established by level of importance of the determining factors for the use of Nivestim and was categorized as profile 1= not applicable, profile 2= relatively unimportant and profile 3 = not important. A multiple correspondence analysis was conducted on the whole analysis population in order to identify possible different patient profiles. None of these profiles could have been associated to a type of chemotherapy (adjuvant or metastatic).
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Use of Biosimilar Nivestim® to Prevent Chemo-induced Neutropenia. Real Life Study
Official Title PROPHYLACTIC TREATMENT FOR CHEMO-INDUCED NEUTROPENIA. USE OF G-CSF BIOSIMILAR (NIVESTIM(REGISTERED)) ACCORDING TO THE CHEMOTHERAPY CONTEXT: ADJUVANT VERSUS METASTATIC.
Brief Summary The aim of this study is to describe in real-life conditions the determinants of use of GCSF (Granulocyte Colony-Stimulating Factor) Nivestim® in primary or secondary prophylaxis and in patients receiving chemotherapy for solid tumour according to the chemotherapy context: adjuvant or metastatic setting.
Detailed Description

This is a longitudinal, observational, prospective, multicentre, cohort study, conducted in France among a representative sample of public and/or private hospital-based oncologists.

Data will be collected by the investigator during three visits using data available in the patient medical record and obtained from patient questioning and clinical examination performed during the consultations:

  • Baseline visit: prescription of Nivestim®.
  • Follow-up visit: during the first cycle of chemotherapy after the first course of Nivestim®.
  • Final visit: after the last cycle of chemotherapy or 16-18 weeks after inclusion.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with solid tumour treated with cytotoxic chemotherapy and for whom a prophylactic treatment with G-CSF biosimilar (Nivestim®) is initiated
Condition Chemotherapy-Induced Neutropenia
Intervention Biological: Nivestim®
Study Groups/Cohorts Cancer patients treated with Nivestim®
Intervention: Biological: Nivestim®
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 Terminated
Actual Enrollment
 (submitted: March 29, 2019)
1160
Original Estimated Enrollment
 (submitted: May 26, 2015)
1200
Actual Study Completion Date January 2017
Actual Primary Completion Date October 18, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients aged at least 18 years, seen by the oncologist for chemotherapy for solid tumour.
  • Patients for whom the oncologist has decided the initiation of G-CSF biosimilar treatment (Nivestim®) in primary or secondary prophylaxis.
  • Patients informed about the computer processing of their medical data and their right of access and correction.

Exclusion Criteria:

  • Patients with contraindication of use of Nivestim®.
  • Patients with haematological malignancy including Myelodysplasia and Chronic myeloid leukemia treated or untreated.
  • Patients participating or having participated in the previous month in a clinical trial.
  • Patients refusing to participate in this study.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (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 NCT02454530
Other Study ID Numbers VISTA
C1121007 ( 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 Hospira, now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2019