Neuroendocrine TumorsPhase 2NCT04672876
Telotristat Ethyl for Reducing Intraoperative Carcinoid Crisis in Patients With Neuroendocrine Tumors
A Phase 2 study testing Telotristat Ethyl Oral Tablet in people with Neuroendocrine Tumors, run by University of Chicago.
Trial summary
This is a study to determine if a certain drug, called telotristat ethyl (Xermelo®), can help reduce the chance of blood pressure and heart rate variations (known as carcinoid crisis) in individuals who have neuroendocrine tumors (also called carcinoid tumors). 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?
- Telotristat Ethyl Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to 1 Oct 2023
- Phase
- Phase 2
- 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
Who may be able to join
- Patients must have a grade 1 or grade 2 small bowel, neuroendocrine tumor (NET) that has been medically confirmed by a physician.
- Patients who plan to have abdominal (stomach) surgery due to cancer that has spread to their liver. Patients must voluntarily choose to have surgery.
- 18 years old or older.
- Patients with small bowel neuroendocrine tumors who are asymptomatic (not showing symptoms) but have elevated serotonin or 5-HIAA (5-hydroxyindoleacetic acid) levels before surgery.
- Patients who are symptomatic (showing carcinoid symptoms) and have elevated or normal Serotonin or 5-HIAA levels (plasma or urinary) before surgery.
Who cannot join
- Patients belonging to vulnerable populations such as children and prisoners.
- Patients with grade 3 neuroendocrine tumors or neuroendocrine tumors that are hard to identify.
- Patients with untreated carcinoid heart disease.
- Patients who are receiving any other drugs or treatment as part of a research study.
- Patients with a "currently active" second tumor other than non-melanoma skin cancers. Patients are not considered to have a "currently active" tumor if they have completed therapy and are free of disease for 3 or more years.
- Patients with known brain cancers.
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- Patients who have a history of allergic reactions to medications that have similar chemical or biologic ingredients as those found in telotristat ethyl.
- Uncontrolled illness that occurs while having cancer such as, but not limited to, ongoing or active infection, congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit the patient's ability to follow study requirements.
- Pregnant women are excluded from this study because telotristat ethyl can severely damage an embryo/fetus or cause an abortion. Because the drug also poses unknown, potential risks for nursing infants, breastfeeding should be discontinued if the mother is treated with telotristat ethyl.
- Women of childbearing age who refuse to take a urinary pregnancy test and refuse to use an acceptable method of birth control during the time of the study and for at least 7 days after surgery. Acceptable contraception includes barrier method (male or female condom); hormonal (oral or implantable); documented sterilization procedure; cap, diaphragm, or sponge with spermicide; or abstinence as a lifestyle choice.
- Patients on CYP3A4 substrates that cannot be stopped due to medical concerns for 15 days prior to surgery.
- Patients with moderate or severe liver failure.
About this study
Official title: Telotristat Ethyl for Reducing the Incidence of Intraoperative Carcinoid Crisis in Patients With Small Bowel Neuroendocrine Tumors
This is a study to determine if a certain drug, called telotristat ethyl (Xermelo®), can help reduce the chance of blood pressure and heart rate variations (known as carcinoid crisis) in individuals who have neuroendocrine tumors (also called carcinoid tumors). These complications can be life-threatening for patients who already have to experience challenging surgeries to remove their tumors. To determine if telotristat ethyl (Xermelo®) will help reduce these complications during surgery, researchers will give the drug to study participants before surgery.
Read the detailed description
What is carcinoid crisis and why study telotristat ethyl to help reduce it? Surgery and anesthesia can cause sudden, dangerous, difficult-to-control changes in blood pressure and heart rate (a "carcinoid crisis") in patients with carcinoid tumors. Patients who have crises for a duration of 10 minutes or longer have a 12-fold increased risk of major complications during surgery.
Historically, it has been believed that crises were due to a massive release of carcinoid hormones from tumors in the blood; therefore, this study will investigate if telotristat ethyl (Xermelo®) can help block this hormone release and reduce the rate of dangerous complications that patients with carcinoid tumors may experience during surgery to remove their tumors.
What will this study involve and how long will it last for participants? The study involves blood tests before, during and after surgery, and taking telotristat ethyl (Xermelo®) tablets orally for two weeks before surgery and on the day of surgery (no later than 2 hours prior to surgery).
- Conditions
- Neuroendocrine Tumors
- Being tested
- Telotristat Ethyl Oral Tablet
- Keywords
- neuroendocrine tumors, carcinoid crisis, carcinoid tumors, surgery for carcinoid tumor, telotristat ethyl
- Medical subject headings
- Neuroendocrine Tumors, Carcinoid Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telotristat Ethyl Oral TabletDrug
Also called Xermelo
XERMELO is a prescription pill, used along with somatostatin analog (SSA) therapy, for Carcinoid Syndrome diarrhea in adults who are not adequately controlled by SSA therapy. The drug is currently FDA-approved for this use but this study has received special approval from the FDA (under an Investigational Drug Application) to study telotristat ethyl in individuals with carcinoid tumors who plan to undergo surgery.
| Study group | Role | What they receive |
|---|---|---|
| Telotristat Ethyl (Xermelo®) | Experimental | After the surgery is performed, study participants will stop taking telotristat ethyl (Xermelo®) as part of this study and there will be no follow-up visits or calls required outside of the usual postoperative care. The research team will collect clinical data on the participants' outcomes up to 30 days after surgery by accessing medical records. Receives: Drug: Telotristat Ethyl Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Observed Carcinoid Crises During Surgery
To determine if surgical treatment with telotristat ethyl reduces the incidence of carcinoid crisis during surgery for participants with small bowel neuroendocrine tumors by comparing data from this study to data from previous research.
Measured: 15 days (including day of surgery).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study startJan 2022 (estimated)
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Oct 2023 (estimated)
Why it stopped: Trial funding no longer available.
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 University of ChicagoThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04672876
- Sponsor's protocol ID
- IRB20-0207
- Status last verified
- Dec 2021
- First submitted
- 29 Sep 2020
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telotristat Ethyl for Reducing the Incidence of Intraoperative Carcinoid Crisis in Patients With Small Bowel Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT04672876
- Acronym / sponsor ID
- IRB20-0207
- Conditions
- Neuroendocrine Tumors
- Keywords
- neuroendocrine tumors, carcinoid crisis, carcinoid tumors, surgery for carcinoid tumor, telotristat ethyl
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Trial funding no longer available.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 17 Dec 2020 (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.
This is a study to determine if a certain drug, called telotristat ethyl (Xermelo®), can help reduce the chance of blood pressure and heart rate variations (known as carcinoid crisis) in individuals who have neuroendocrine tumors (also called carcinoid tumors). These complications can be life-threatening for patients who already have to experience challenging surgeries to remove their tumors. To determine if telotristat ethyl (Xermelo®) will help reduce these complications during surgery, researchers will give the drug to study participants before surgery.
Detailed description
What is carcinoid crisis and why study telotristat ethyl to help reduce it? Surgery and anesthesia can cause sudden, dangerous, difficult-to-control changes in blood pressure and heart rate (a "carcinoid crisis") in patients with carcinoid tumors. Patients who have crises for a duration of 10 minutes or longer have a 12-fold increased risk of major complications during surgery.
Historically, it has been believed that crises were due to a massive release of carcinoid hormones from tumors in the blood; therefore, this study will investigate if telotristat ethyl (Xermelo®) can help block this hormone release and reduce the rate of dangerous complications that patients with carcinoid tumors may experience during surgery to remove their tumors.
What will this study involve and how long will it last for participants? The study involves blood tests before, during and after surgery, and taking telotristat ethyl (Xermelo®) tablets orally for two weeks before surgery and on the day of surgery (no later than 2 hours prior to surgery).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telotristat Ethyl (Xermelo®) | Experimental | Drug: Telotristat Ethyl Oral TabletAfter the surgery is performed, study participants will stop taking telotristat ethyl (Xermelo®) as part of this study and there will be no follow-up visits or calls required outside of the usual postoperative care. The research team will collect clinical data on the participants' outcomes up to 30 days after surgery by accessing medical records. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients must have a grade 1 or grade 2 small bowel, neuroendocrine tumor (NET) that has been medically confirmed by a physician.
- Patients who plan to have abdominal (stomach) surgery due to cancer that has spread to their liver. Patients must voluntarily choose to have surgery.
- 18 years old or older.
- Patients with small bowel neuroendocrine tumors who are asymptomatic (not showing symptoms) but have elevated serotonin or 5-HIAA (5-hydroxyindoleacetic acid) levels before surgery.
- Patients who are symptomatic (showing carcinoid symptoms) and have elevated or normal Serotonin or 5-HIAA levels (plasma or urinary) before surgery.
Key exclusion criteria (12 listed)
- Patients belonging to vulnerable populations such as children and prisoners.
- Patients with grade 3 neuroendocrine tumors or neuroendocrine tumors that are hard to identify.
- Patients with untreated carcinoid heart disease.
- Patients who are receiving any other drugs or treatment as part of a research study.
- Patients with a "currently active" second tumor other than non-melanoma skin cancers. Patients are not considered to have a "currently active" tumor if they have completed therapy and are free of disease for 3 or more years.
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 |
|---|---|---|
| Telotristat Ethyl Oral TabletAlso: XermeloXERMELO is a prescription pill, used along with somatostatin analog (SSA) therapy, for Carcinoid Syndrome diarrhea in adults who are not adequately controlled by SSA therapy. The drug is currently FDA-approved for this use but this study has received special approval from the FDA (under an Investigational Drug Application) to study telotristat ethyl in individuals with carcinoid tumors who plan to undergo surgery. | Drug | Telotristat Ethyl (Xermelo®) |
Primary outcome
Number of Participants with Observed Carcinoid Crises During Surgery
Time frame: 15 days (including day of surgery).
To determine if surgical treatment with telotristat ethyl reduces the incidence of carcinoid crisis during surgery for participants with small bowel neuroendocrine tumors by comparing data from this study to data from previous research.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Telotristat Ethyl Oral Tablet in people with Neuroendocrine Tumors, run by University of Chicago.
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 5 inclusion and 12 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: withdrawn, as of the sponsor's last update on 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of Participants with Observed Carcinoid Crises During Surgery (time frame: 15 days (including day of surgery).). 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 17 Dec 2021.