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Serotonin Inhibitor
Telotristat Ethyl for Neuroendocrine Tumors
Phase 3
Waitlist Available
Led By Saamir A Hassan
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histopathologically-confirmed, metastatic neuroendocrine tumor and/or locally/regionally advanced neuroendocrine tumor
Adequate methods of contraception, defined as having a failure rate of < 1% per year, for patients or their partner include the following: condom with spermicidal gel, diaphragm with spermicidal gel, intrauterine device, surgical sterilization, vasectomy, oral contraceptive pill, depo-progesterone injections, progesterone implant (ie, Implanon), patch (Ortho Evra), NuvaRing, and abstinence. If a patient is not sexually active but becomes active, he or his partner should use medically accepted forms of contraception
Must not have
Patients receiving everolimus due to poor response to SSA
Arrhythmia causing hemodynamic compromise
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
Summary
This trial is comparing telotristat ethyl to the current standard of care, somatostatin analog therapy, in treating patients with neuroendocrine tumors that have spread to other parts of the body.
Who is the study for?
Adults (18+) with metastatic neuroendocrine tumors and carcinoid syndrome, currently on stable somatostatin analog therapy. They must be able to consent, use effective contraception if of childbearing potential, and have an ECOG performance status of 0-2. Exclusions include prior telotristat ethyl use within 3 months, significant cardiac issues, severe liver or kidney impairment, pregnancy/lactation, short life expectancy (<6 months), recent other cancer treatments or investigational drugs.
What is being tested?
This phase III trial is testing whether adding telotristat ethyl to standard somatostatin analog therapy is more effective than the standard therapy alone in controlling symptoms and heart disease related to carcinoid syndrome in patients with metastatic neuroendocrine tumors.
What are the potential side effects?
Potential side effects may include gastrointestinal issues such as constipation or diarrhea, fatigue, headache, depression or mood changes. There's also a risk for liver enzyme elevations which could indicate liver damage.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is a confirmed neuroendocrine tumor that has spread or is advanced locally.
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I am using or willing to use effective birth control or practice abstinence.
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I have a documented history of carcinoid syndrome.
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I am 18 years old or older.
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I am taking Lanreotide 120 mg every 4 weeks.
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I can perform daily activities with little to no assistance.
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I am taking Octreotide LAR 30 mg every 4 weeks.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am taking everolimus because my previous treatment didn't work well.
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I have a heart rhythm problem that affects my blood circulation.
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I have severe heart valve problems causing symptoms.
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I am able to communicate and cooperate with my doctor.
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My kidney function is low, with an eGFR below 30 ml/min.
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I have had chest pain with signs of heart strain on an ECG.
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I have severe heart failure symptoms.
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I haven't taken any experimental drugs for carcinoid syndrome or heart disease in the last 30 days.
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I have not taken XERMELO in the last 3 months.
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I have unstable chest pain.
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I have had ongoing constipation or a blockage in my bowels in the last 6 months.
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I have a history of conditions causing diarrhea not related to carcinoid syndrome.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (telotristat ethyl, SSA)Experimental Treatment2 Interventions
Patients receive telotristat ethyl PO TID and SSA for 6 months in the absence of disease progression or unacceptable toxicity.
Group II: Arm B (placebo, SSA)Active Control2 Interventions
Patients receive placebo PO TID and SSA for 6 months in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Telotristat Ethyl
2017
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
TerSera Therapeutics LLCIndustry Sponsor
9 Previous Clinical Trials
1,262 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
3,066 Previous Clinical Trials
1,802,166 Total Patients Enrolled
Saamir A HassanPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My heart condition won't risk my safety or affect the study's results.I am taking everolimus because my previous treatment didn't work well.Your doctor thinks you have less than 6 months to live.I have a heart rhythm problem that affects my blood circulation.I do not have serious heart rhythm problems that could affect my safety or the study results.I have severe heart valve problems causing symptoms.I don't have any health issues that could risk my safety in the study.I agree to use birth control during and for 30 days after the study.I have been treated for cancer other than neuroendocrine tumor, but it's considered cured.I am taking the highest dose of SSA therapy that I can tolerate.You have had issues with digesting galactose or lactose in the past.I am able to communicate and cooperate with my doctor.I haven't had cancer treatments like chemotherapy or radiation in the last 4 weeks.My kidney function is low, with an eGFR below 30 ml/min.I am capable of becoming pregnant because I have not been sterilized and am not postmenopausal.My cancer is a confirmed neuroendocrine tumor that has spread or is advanced locally.I am using or willing to use effective birth control or practice abstinence.I have had chest pain with signs of heart strain on an ECG.I have severe heart failure symptoms.I haven't taken any experimental drugs for carcinoid syndrome or heart disease in the last 30 days.I have not taken XERMELO in the last 3 months.I have unstable chest pain.I have a documented history of carcinoid syndrome.I am 18 years old or older.I have had ongoing constipation or a blockage in my bowels in the last 6 months.You have any other significant abnormality in your lab tests that could potentially harm you or affect the study results, according to the primary investigator's decision.I am on a stable dose of long-acting or depot hormone therapy.I am taking Lanreotide 120 mg every 4 weeks.I have been on a stable dose of somatostatin analog therapy for at least 2 months.I can perform daily activities with little to no assistance.I have a history of conditions causing diarrhea not related to carcinoid syndrome.You have had problems with drugs or alcohol in the past 2 years, as defined by the DSM-V guidelines.I am taking Octreotide LAR 30 mg every 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (placebo, SSA)
- Group 2: Arm A (telotristat ethyl, SSA)
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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