Neuroendocrine TumorsNCT03112694
Switching From Octreotide to Lanreotide - A Look Back at Patients With Neuroendocrine Tumors
An observational study of Neuroendocrine Tumors, run by Ipsen at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- Data collection
- How many people
- 93 participants
- Where
- 8 sitesUnited States
- Study dates
- 4 Apr 2017to 2 Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitals and clinics
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Mercy Medical Center
Baltimore, Maryland, 21202
Tufts Medical Center
Boston, Massachusetts, 02111
National Transitional Research
East Setauket, New York, 11733
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Allegheny Cancer Center
Pittsburgh, Pennsylvania, 15212
Mayo Clinic
Rochester, Minnesota, 55905
Moffitt Cancer Center
Tampa, Florida, 33612
Cancer Center of Kansas
Wichita, Kansas, 67214
About this study
Official title: A Multicenter, Retrospective, Medical Record Review Of The Effectiveness Of Lanreotide Following Treatment With Octreotide In Patients With Neuroendocrine Tumors
The purpose of this study is to understand how people with neuroendocrine tumors respond to treatment with lanreotide after having received treatment with octreotide.
- Conditions
- Neuroendocrine Tumors
- Being tested
- Data collection
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to treatment
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)
Measured: 4 months (data collection duration)
Secondary outcomes (8)
Progression-free survival, after treatment with octreotide
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.
Measured: 4 months (data collection duration)
Duration of response to lanreotide, after treatment with octreotide
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.
Measured: 4 months (data collection duration)
Duration of treatment with octreotide and duration of treatment with lanreotide
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).
Measured: 4 months (data collection duration)
Severity of Adverse Events
Summarized separately during treatment with octreotide and during treatment with lanreotide, as available
Measured: 4 months (data collection duration)
Reasons for switching from octreotide to lanreotide
Summarized descriptively
Measured: 4 months (data collection duration)
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
Summarized descriptively
Measured: 4 months (data collection duration)
Levels of Chromogranin A (CgA) before treatment with octreotide, during treatment with octreotide and during treatment with lanreotide, as available
Summarized descriptively
Measured: 4 months (data collection duration)
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
Proportion of patients reporting each symptom
Measured: 4 months (data collection duration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start4 Apr 2017
- Primary completion2 Nov 2017
- Study completion2 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03112694
- Sponsor's protocol ID
- A-US-52030-364
- Status last verified
- Jun 2020
- First submitted
- 7 Apr 2017
- Last updated
- 2 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Retrospective, Medical Record Review Of The Effectiveness Of Lanreotide Following Treatment With Octreotide In Patients With Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT03112694
- Acronym / sponsor ID
- A-US-52030-364
- Conditions
- Neuroendocrine Tumors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 4 Apr 2017 (actual)
- Primary completion
- 2 Nov 2017 (actual)
- Study completion
- 2 Nov 2017 (actual)
- First posted
- 13 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to understand how people with neuroendocrine tumors respond to treatment with lanreotide after having received treatment with octreotide.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitals and clinics
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionThis 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. | Other | – |
Primary outcome
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)
8 secondary outcomes
Progression-free survival, after treatment with octreotide
Time frame: 4 months (data collection duration)
Duration of response to lanreotide, after treatment with octreotide
Time frame: 4 months (data collection duration)
Duration of treatment with octreotide and duration of treatment with lanreotide
Time frame: 4 months (data collection duration)
Severity of Adverse Events
Time frame: 4 months (data collection duration)
Reasons for switching from octreotide to lanreotide
Time frame: 4 months (data collection duration)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
Related trials for Neuroendocrine Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
RecruitingPhase 2
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
Carcinoma, Neuroendocrine, Tumor, Neuroendocrine
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 3
Somatostatin Analogues vs. Observation After Peptide Receptor Radionuclide Therapy (PRRT) in Nonfunctional Neuroendocrine Neoplasms
Neuroendocrine Neoplasm, Gastroenteropancreatic Neuroendocrine Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroendocrine Tumors, run by Ipsen at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to treatment (time frame: 4 months (data collection duration)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2020.