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Switching From Octreotide to Lanreotide - A Look Back at Patients With Neuroendocrine Tumors

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ClinicalTrials.gov Identifier: NCT03112694
Recruitment Status : Completed
First Posted : April 13, 2017
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
Ipsen

Tracking Information
First Submitted Date April 7, 2017
First Posted Date April 13, 2017
Last Update Posted Date December 21, 2018
Actual Study Start Date April 4, 2017
Actual Primary Completion Date November 2, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 7, 2017)
Response to treatment [ Time Frame: 4 months (data collection duration) ]
Evaluated as responsive disease (i.e., complete response, partial response), stable disease or progressive disease at the last tumor assessment while on treatment with lanreotide (based on tumor imaging, symptoms, biomarker(s) and/or clinical judgement)
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03112694 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 7, 2017)
  • Progression-free survival, after treatment with octreotide [ Time Frame: 4 months (data collection duration) ]
    For evaluating progression-free survival events will include radiographic progression per investigator, biomarker progression per investigator, symptom progression per investigator, and death. Adverse events (AEs) will not be considered as an event.
  • Duration of response to lanreotide, after treatment with octreotide [ Time Frame: 4 months (data collection duration) ]
    For evaluating duration of response events will include radiographic progression per investigator, biomarker progression per investigator, symptom progression per investigator, AEs, and death. Open ended responses will be reviewed during the analysis and determined to be an eligible "event" or not at that time.
  • Duration of treatment with octreotide and duration of treatment with lanreotide [ Time Frame: 4 months (data collection duration) ]
    Duration of octreotide treatment assessed as time from start of octreotide treatment to stop of octreotide treatment. Duration of lanreotide treatment assessed as time from lanreotide initiation to end of lanreotide treatment (censored at the date of last administration (+lanreotide frequency) for patients who had ongoing lanreotide treatment).
  • Severity of Adverse Events [ Time Frame: 4 months (data collection duration) ]
    Summarized separately during treatment with octreotide and during treatment with lanreotide, as available
  • Reasons for switching from octreotide to lanreotide [ Time Frame: 4 months (data collection duration) ]
    Summarized descriptively
  • Levels of 5-hydroxyindoleacetic acid (5-HIAA) (urine test or blood test) before treatment with octreotide, during treatment with octreotide and during treatment with lanreotide, as available [ Time Frame: 4 months (data collection duration) ]
    Summarized descriptively
  • Levels of Chromogranin A (CgA) before treatment with octreotide, during treatment with octreotide and during treatment with lanreotide, as available [ Time Frame: 4 months (data collection duration) ]
    Summarized descriptively
  • Severity of symptoms (i.e., flushing, diarrhea, dyspnea, abdominal pain, edema, nausea) before treatment with octreotide, during treatment with octreotide, and during treatment with lanreotide, as available [ Time Frame: 4 months (data collection duration) ]
    Proportion of patients reporting each symptom
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Switching From Octreotide to Lanreotide - A Look Back at Patients With Neuroendocrine Tumors
Official Title A Multicenter, Retrospective, Medical Record Review Of The Effectiveness Of Lanreotide Following Treatment With Octreotide In Patients With Neuroendocrine Tumors
Brief Summary The purpose of this study is to understand how people with neuroendocrine tumors respond to treatment with lanreotide after having received treatment with octreotide.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Hospitals and clinics
Condition Neuroendocrine Tumors
Intervention Other: Data collection
This is a non-interventional study, the decision to prescribe the product would have been taken prior to, and independently from the decision to enrol the patient.
Study Groups/Cohorts Not Provided
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: January 26, 2018)
93
Original Estimated Enrollment
 (submitted: April 7, 2017)
100
Actual Study Completion Date November 2, 2017
Actual Primary Completion Date November 2, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Males and females age 18 years or older at time of locally advanced or metastatic diagnosis
  • Patients with a confirmed diagnosis of locally advanced or metastatic Gastroenteropancreatic neuroendocrine tumour (GEP-NET)
  • Patients who switched treatment from long acting octreotide LAR to lanreotide, where both treatments were received for the treatment of locally advanced or metastatic GEP-NET. i. Treatment with long acting octreotide LAR monotherapy for at least 90-days before treatment with lanreotide monotherapy (rescue SSA# use permitted). ii. Treatment with lanreotide monotherapy for at least 90-days after treatment with long acting octreotide monotherapy (rescue SSA# use permitted)

Exclusion Criteria:

  • Patients with other malignant disease
  • Patients who participated in a concomitant clinical trial related to treatment of GEP-NET
  • Patients being treated with a Somatostatin analogue (SSA) in combination with other NET treatments excluding rescue SSA#
  • Patients who received other primary treatment (e.g., targeted therapy, chemotherapy) for GEP-NET during the interval between octreotide and lanreotide
  • Patients with NET familial genetic syndrome (i.e., MEN1)
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03112694
Other Study ID Numbers A-US-52030-364
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement Not Provided
Responsible Party Ipsen
Study Sponsor Ipsen
Collaborators Not Provided
Investigators
Study Director: Ipsen Medical Director Ipsen
PRS Account Ipsen
Verification Date December 2018