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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

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.

Condition or disease Intervention/treatment
Neuroendocrine Tumors Other: Data collection

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Study Type : Observational
Actual Enrollment : 93 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Multicenter, Retrospective, Medical Record Review Of The Effectiveness Of Lanreotide Following Treatment With Octreotide In Patients With Neuroendocrine Tumors
Actual Study Start Date : April 4, 2017
Actual Primary Completion Date : November 2, 2017
Actual Study Completion Date : November 2, 2017

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.


Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. Severity of Adverse Events [ Time Frame: 4 months (data collection duration) ]
    Summarized separately during treatment with octreotide and during treatment with lanreotide, as available

  5. Reasons for switching from octreotide to lanreotide [ Time Frame: 4 months (data collection duration) ]
    Summarized descriptively

  6. 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

  7. 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

  8. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Hospitals and clinics
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03112694


Locations
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United States, Florida
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Kansas
Cancer Center of Kansas
Wichita, Kansas, United States, 67214
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Maryland
Mercy Medical Center
Baltimore, Maryland, United States, 21202
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
National Transitional Research
East Setauket, New York, United States, 11733
United States, Pennsylvania
Allegheny Cancer Center
Pittsburgh, Pennsylvania, United States, 15212
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen

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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT03112694     History of Changes
Other Study ID Numbers: A-US-52030-364
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Octreotide
Lanreotide
Angiopeptin
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents