Carcinoid SyndromeRELAXNCT03223428

Real-world Evidence Study EvaLuating PAtient-Reported Outcomes With XERMELO

An observational study of Carcinoid Syndrome, run by TerSera Therapeutics LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The primary objective of the study is to estimate the proportion of carcinoid syndrome (CS) patients who are satisfied with their overall symptom control, 6 months after initiating treatment with telotristat ethyl (XERMELO). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Carcinoid Syndrome
What is being tested?: Xermelo
How many people: 223 participants
Where: 1 siteUnited States
Study dates: 22 Jun 2017to 14 Jan 2022
How long will I take part?: 3 Years
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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: The study will include patients with CS and who are initiating treatment with XERMELO.

Who may be able to join

Adult, ≥18 years of age at the time of informed consent
A new, valid prescription for XERMELO
Initiating XERMELO for the treatment of carcinoid syndrome
Able and willing to provide informed consent prior to participation in the study

Who cannot join

Unable to understand and read English
Unable to access the internet
Prior exposure to XERMELO

Trial locations and contacts

1 site in 1 country.

United States1 site

RTI-HS
Research Triangle Park, North Carolina, 27709

Other trials in United States

About this study

Official title: An Observational Study to Evaluate the Real-world Experience of Patients Who Are Initiating Treatment With Telotristat Ethyl (XERMELO™)

Read the detailed description

This study will evaluate patient-reported outcomes for adults initiating telotristat ethyl (XERMELO) for carcinoid syndrome diarrhea (CSD) not adequately controlled by somatostatin analogs in US clinical practice. The primary objective is satisfaction with overall CS symptom control 6 months after starting XERMELO. Secondary objectives will evaluate satisfaction with control of CSD and flushing, CS symptoms, work productivity and activity impairment, SSA use, and weight. This study will provide real-world patient-reported outcomes in CS with XERMELO treatment for at least 6 months.

Conditions: Carcinoid Syndrome
Being tested: Xermelo
Keywords: neuroendocrine tumors, carcinoid syndrome, telotristat ethyl
Medical subject headings: Serotonin Syndrome, Neuroendocrine Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

XermeloDrug
Also called Telotristat ethyl
This study will include patients with carcinoid syndrome who are initiating treatment with XERMELO.

Study groups in NCT03223428
Study group	Role	What they receive
Carcinoid Syndrome patients initiating Xermelo		Patients with Carcinoid Syndrome who are initiating treatment with XERMELO. Receives: Drug: Xermelo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Patients Who Are Satisfied With Their Overall Symptom Control
The percentage of CS patients who are satisfied with their overall symptom control, 6 months after initiating treatment with telotristat ethyl (XERMELO). Satisfaction with how Xermelo has controlled diarrhea, flushing, and overall CS symptoms was assessed at the initial 6-month follow-up. The questionnaire allowed participants to choose a response on a 5-level Likert scale ranging from "Very dissatisfied" (level 1) to "Very satisfied" (level 5). For the assessments of satisfaction with control of diarrhea and flushing, "Not applicable" (level 0) was a response option for participants who do not have the particular symptom that is being assessed.
Measured: Baseline to 6 months

Secondary outcomes (8)

Percentage of Patients Reporting Satisfaction of CS-related Diarrhea Control
Estimate percentage of patients reporting satisfaction with CS-related diarrhea control from Baseline to 6 months after starting Xermelo. At baseline participants were asked, "Currently, how satisfied are you with how your diarrhea is controlled?" At the 6-month follow-up survey, participants were asked, "Currently, how satisfied are you with how Xermelo has controlled your diarrhea?"
Measured: Baseline to 6 months
Percentage of Patients Reporting Satisfaction of CS- Related Flushing Control
Estimate percentage of patients reporting satisfaction with CS-related flushing control from Baseline to 6 Months. At baseline, participants who had reported flushing as a symptom were asked, "Currently, how satisfied are you with how your flushing is controlled?" At 6 months, participants who had reported flushing as a symptom at Baseline were asked, "Currently, how satisfied are you with how Xermelo has controlled your flushing?"
Measured: Baseline to 6 months
Number of Patients Reporting Reduction in Rescue SSA Use
Number of participants reporting a reduction in rescue SSA use at 6 months after initiating treatment with Xermelo.
Measured: Baseline to 6 months
Percentage of Patients Reporting Reduction in the Dose of Long-acting SSA Injection
Percentage of patients reporting a reduction in the dose of long-acting SSA injection 6 months after patients initiated treatment with Xermelo
Measured: Baseline to 6 months
Percentage of Patients Reporting Reduction in the Frequency of Long-acting SSA Injection
Estimate Percentage of Patients Reporting Reduction in the Frequency of Long-acting SSA Injection 6 months after patients initiated treatment with Xermelo
Measured: Baseline to 6 months
Percentage of Patients Reporting an Overall Improvement in CS Symptom Control Based on Patient Global Impression of Change (PGIC)
Estimate percentage of patients reporting an overall improvement in CS symptom control (diarrhea, flushing, frequency of BMs) after initiating Xermelo based on Patient Global Impression of Change (PGIC)
Measured: Baseline to 6 months
Percentage Change of Patients Who Had Reduction in Work-related Absenteeism, Presenteeism, Activity Impairment, and Overall Productivity Loss From Baseline to 6 Months After Initiating Telotristat Ethyl Based on WPAI-SHP
Estimate of the percentage of patients who had reduction in work-related absenteeism, presenteeism, activity impairment, and overall productivity loss based on Worker Productivity and Activity Impairment: Specific Health Problem v2.0 (WPAI- SHP). The percentage change was measured from baseline to 6 months after treatment with telotristat ethyl.
Measured: Baseline to 6 months
Percentage of Patients Reporting Weight Gain
Estimate of the percentage of patients reporting weight gain after initiating Xermelo therapy.
Measured: Baseline to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jun 201714 Jan 2022

First posted21 Jul 2017
Study start22 Jun 2017
Primary completion14 Jan 2022
Study completion14 Jan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Carcinoid SyndromeStudies of the same condition, open and under way.
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: Prospective
Enrolment: 223 participants (actual)
Target duration: 3 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT03223428
Sponsor's protocol ID: LX1606.1-401-CS
Other IDs: LX1606.401
Acronym: RELAX
Status last verified: Jul 2024
First submitted: 18 Jul 2017
Last updated: 24 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Li D, Darden C, Osman N, Sayeed S, Jackson L, Garbinsky D, Chauhan A. Real-World Clinical and Patient-Reported Outcomes from the Longitudinal Telotristat Ethyl Treatment Registry of Patients with Neuroendocrine Tumors. Cancer Manag Res. 2022 Oct 17;14:3009-3020. doi: 10.2147/CMAR.S386419. eCollection 2022.
PubMed 36262750

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Lenvatinib and Everolimus in Treating Patients With Advanced, Unresectable Carcinoid Tumors
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An Investigational Scan (Dual Energy CT) in Detecting Gastrointestinal Carcinoid Tumors
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Investigation of a Transcatheter Tricuspid Valved Stent Graft in Patients With Carcinoid Heart Disease
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All Carcinoid Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Observational Study to Evaluate the Real-world Experience of Patients Who Are Initiating Treatment With Telotristat Ethyl (XERMELO™)
ClinicalTrials.gov ID: NCT03223428
Acronym / sponsor ID: RELAX / LX1606.1-401-CS
Conditions: Carcinoid Syndrome
Keywords: neuroendocrine tumors, carcinoid syndrome, telotristat ethyl
Study type: Observational
Recruitment status: Completed
Enrolment: 223 participants (actual)
Lead sponsor: TerSera Therapeutics LLCIndustry (pharma, biotech, devices)
Study start: 22 Jun 2017 (actual)
Primary completion: 14 Jan 2022 (actual)
Study completion: 14 Jan 2022 (actual)
First posted: 21 Jul 2017 (actual)
Results: Posted 15 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 3 Years
Number of arms: 1

Arm	Type	Receives
Carcinoid Syndrome patients initiating Xermelo	–	Drug: XermeloPatients with Carcinoid Syndrome who are initiating treatment with XERMELO.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The study will include patients with CS and who are initiating treatment with XERMELO.

Key inclusion criteria (4 listed)

Adult, ≥18 years of age at the time of informed consent
A new, valid prescription for XERMELO
Initiating XERMELO for the treatment of carcinoid syndrome
Able and willing to provide informed consent prior to participation in the study

Key exclusion criteria (3 listed)

Unable to understand and read English
Unable to access the internet
Prior exposure to XERMELO

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
XermeloAlso: Telotristat ethylThis study will include patients with carcinoid syndrome who are initiating treatment with XERMELO.	Drug	Carcinoid Syndrome patients initiating Xermelo

Primary outcome

Percentage of Patients Who Are Satisfied With Their Overall Symptom Control
Time frame: Baseline to 6 months
The percentage of CS patients who are satisfied with their overall symptom control, 6 months after initiating treatment with telotristat ethyl (XERMELO). Satisfaction with how Xermelo has controlled diarrhea, flushing, and overall CS symptoms was assessed at the initial 6-month follow-up. The questionnaire allowed participants to choose a response on a 5-level Likert scale ranging from "Very dissatisfied" (level 1) to "Very satisfied" (level 5). For the assessments of satisfaction with control of diarrhea and flushing, "Not applicable" (level 0) was a response option for participants who do not have the particular symptom that is being assessed.

8 secondary outcomes

Percentage of Patients Reporting Satisfaction of CS-related Diarrhea Control
Time frame: Baseline to 6 months
Percentage of Patients Reporting Satisfaction of CS- Related Flushing Control
Time frame: Baseline to 6 months
Number of Patients Reporting Reduction in Rescue SSA Use
Time frame: Baseline to 6 months
Percentage of Patients Reporting Reduction in the Dose of Long-acting SSA Injection
Time frame: Baseline to 6 months
Percentage of Patients Reporting Reduction in the Frequency of Long-acting SSA Injection
Time frame: Baseline to 6 months
Percentage of Patients Reporting an Overall Improvement in CS Symptom Control Based on Patient Global Impression of Change (PGIC)
Time frame: Baseline to 6 months
Percentage Change of Patients Who Had Reduction in Work-related Absenteeism, Presenteeism, Activity Impairment, and Overall Productivity Loss From Baseline to 6 Months After Initiating Telotristat Ethyl Based on WPAI-SHP
Time frame: Baseline to 6 months
Percentage of Patients Reporting Weight Gain
Time frame: Baseline to 6 months

Results and safety

Results posted to the registry on 15 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Carcinoid Syndrome Patients Initiating Xermelo	223	125

Primary outcome: Percentage of Patients Who Are Satisfied With Their Overall Symptom Control

Time frame: Baseline to 6 months. Count of participants. Unit: Participants

Measure	Carcinoid Syndrome Patients Initiating Xermelo n = 125
Very Satisfied with symptom control	37
Somewhat satisfied with symptom control	58
Neither satisfied or dissatisfied with symptom control	22
Somewhat dissatisfied with symptom control	5
Very dissatisfied with symptom control	3

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events not collected as part of the survey.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Carcinoid Syndrome Patients Initiating Xermelo	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): A potential for responder bias was possible as results were self-reported. Decreased number of responders presented challenges to interpretation after approx. 24-30 months, hence findings should be interpreted with caution. Adverse event safety data collection: Out of scope of this study. Reported adverse events, if occurred, were to be collected and reported to the Sponsor outside of the survey collection process.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 36262750Li D, Darden C, Osman N, Sayeed S, Jackson L, Garbinsky D, Chauhan A. Real-World Clinical and Patient-Reported Outcomes from the Longitudinal Telotristat Ethyl Treatment Registry of Patients with Neuroendocrine Tumors. Cancer Manag Res. 2022 Oct 17;14:3009-3020. doi: 10.2147/CMAR.S386419. eCollection 2022.
Prospective, observational, single-arm study evaluated long-term patient-reported outcomes in adults initiating TE in US clinical practice. The primary objective was satisfaction with overall CS symptom control at 6 months.Link provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Carcinoid Syndrome

Active, not recruitingPhase 3
Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen
Carcinoid Syndrome, Carcinoid
Active, not recruitingPhase 2
Lenvatinib and Everolimus in Treating Patients With Advanced, Unresectable Carcinoid Tumors
Advanced Carcinoid Tumor, Digestive System Neuroendocrine Neoplasm
Active, not recruitingEarly Phase 1
An Investigational Scan (Dual Energy CT) in Detecting Gastrointestinal Carcinoid Tumors
Carcinoid Syndrome, Carcinoid Tumor
Active, not recruiting
Investigation of a Transcatheter Tricuspid Valved Stent Graft in Patients With Carcinoid Heart Disease
Tricuspid Regurgitation, Tricuspid Valve Disease
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma

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.

Janine North, BS study director

TerSera Therapeutics LLC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Carcinoid Syndrome, run by TerSera Therapeutics LLC at 1 site 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 4 inclusion and 3 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 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 15 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Patients Who Are Satisfied With Their Overall Symptom Control (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03223428, which also lists 1 linked publication.

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 24 Jul 2024.