Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Rare Diseases

Recurrence

Biliary Tract Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Biliary Tract Diseases

Gastrointestinal Diseases

Biliary Tract Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Cisplatin

Antimetabolites

Xermelo 250 milligram (mg) plus first line therapy for a week, then Xermelo 500mg plus first line therapy for the duration of the study

XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) three times a day plus first line therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) three times a day plus first line therapy for the duration of the study

telotristat ethyl

Renuka Iyer, M.D.

Richard Kim, M.D.

A Phase 2, multicenter, open-label, 2-stage study to assess the safety, tolerability, and efficacy of XERMELO in combination with first-line (1L) therapy (cisplatin \[cis\] plus gemcitabine \[gem\])

A Phase 2, multicenter, open-label, 2-stage study to assess the safety, tolerability, and efficacy of XERMELO in combination with first-line (1L) therapy cis plus gem in patients with unresectable, locally advanced, recurrent or metastatic biliary tract cancer (intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer), who are naïve to tumor-directed therapy in the locally advanced or metastatic setting, and for which treatment with 1L therapy (defined as a combination of cis plus gem) is planned.

A Safety and Efficacy Study of XERMELO® + First-line Chemotherapy in Patients With Advanced Biliary Tract Cancer

A Phase 2, Multicenter, Open-label, Safety and Efficacy Study of XERMELO® (Telotristat Ethyl) Plus First-line Chemotherapy in Patients With Locally Advanced, Unresectable, Recurrent or Metastatic Biliary Tract Cancer (BTC)

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions", or similar definition as accurate and appropriate.

Overall Survival (OS) was defined as the time from the frist dose of study treatment until the date of death due to any cause. Duration of Overall Survival (OS) in days is defined as (Date of event/censoring- date of First dose +1). Use Kaplan Meier method to project survival rate at month 6.

Overall Survival (OS) was defined as the time from first dose of study treatment until the date of death due to any cause.

Overall Survival (OS) was defined as the time from the first dose of study treatment until the date of death due to any cause. Duration of Overall Survival (OS) in days is defined as (Date of event/censoring - date of first dose +1). Use Kaplan Meier method to project survival rate at month 12.

Scheduled disease assessment at Cycle 19 Day 1 was used to determine PFS response rate at Month 12.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.".

Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR.

Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until the EOS considering any requirement for confirmation.

(CR) + partial response (PR) at Months 6

Overall response rate (ORR) was defined as the proportion of patients (Number of Responders) with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until Month 12.

Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until the EOS considering any requirement for confirmation.

Summary of Duration of Median Progression Free Survival, Local Radiologist's Assessment. Patient progression was defined from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 months.

Summary of Median Progression Free Survival, Local Radiologist's Assessment. Defined as the time from first dose of study treatment until the first date of either disease progression or death due to any cause. Scheduled disease assessment at Cycle 19 Day 1 was used to determine PFS response rate at Month 12.

Summary of Median Progression Free Survival, Local Radiologist's Assessment, End of Study

Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment at Month 6.

Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment at Month 12.

Disease control rate (DCR), Local Reviewer, 6 Months

Mean change from Baseline to Month 6 plasma level 5-hydroxyindoleacetic acid (5-HIAA)

Mean change from Baseline to Month 12 in plasma level 5-hydroxyindoleacetic Acid (5-HIAA)

Mean change from Baseline to End of Study in plasma 5-hydroxyindoleacetic acid (5-HIAA)

Mean change from Baseline to month 6 in plasma carbohydrate antigen 19-9 (CA 19-9)

Mean change from Baseline to Month 12 in plasma carbohydrate antigen 19-9 (CA 19-9)

Mean change from Baseline to End of Study in plasma carbohydrate antigen 19-9 (CA 19-9)

Mean change in weight at Month 6 from baseline measurement

Mean change in weight at Month 12 from baseline measurement

Mean change in weight from baseline to End of Study

Mean change from Baseline to Month 6 serum albumin levels

Mean change from Baseline to Month 12 serum albumin levels

Mean change from Baseline to End of Study serum albumin levels

TerSera Therapeutics LLC

Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study

telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study

Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Height

Weight

Body Mass Index (BMI)

5-HIAA: Normal (\</=) was considered \</= 10.8 micrograms/Liter High (\>ULN) was considered \>10.8 micrograms/Liter

Baseline Plasma 5-Hydroxyindoleacetic Acid (5-HIAA) Levels </= to ULN

Serum CA19-9

Serum CEA

Serum Albumin

This study was halted prematurely as it did not meet pre-specified Progression-Free Survival at Month 6 for Stage 2 Analysis.

Due to early discontinuation of the study with limited data, the study results (data) at Month 12 and End of Study may be unreliable and uninterpretable.

Janine North, Executive Director-Clinical Development

Safety Population

Per Protocol Population

By Treatment Cycle Population

Number of Participants With Progression-free Survival (PFS) as Evaluated by Central Radiologist's Assessment

Project Overall Survival Rate at Month 6

Overall Survival (OS)

Project Overall Survival Rate at Month 12

Median Progression Free Survival

Disease Control Rate (DCR), Central Radiologist's Assessment

Overall (Objective) Response Rate (ORR), Central Radiologist's Assessment

Overall (Objective) Response Rate, Central Radiologist's Assessment

Summary of Duration of Progression Free Survival, Local Radiologist's Assessment

Progression Free Survival, Local Radiologist's Assessment

Overall (Objective) Response Rate, Local Read

Overall (Objective) Response Rate, Local Reader's Assessment

Overall (Objective) Response Rate (ORR), Local Reader's Assessment

Disease Control Rate (DCR), Local Reviewer

Disease Control Rate End of Study, Local Reviewer

Mean Change From Baseline in Plasma 5-hydroxyindoleacetic Acid (5-HIAA)

Change From Baseline in Carbohydrate Antigen 19-9 (CA 19-9)

Change From Baseline in Plasma Carbohydrate Antigen 19-9 (CA 19-9)

Weight Change From Baseline

Change From Baseline in Serum Albumin

Overall Study

Gland and Hormone Related Diseases

Nutritional and Metabolic Diseases

Pancreatic Neoplasms

Body Weight

Neuroendocrine Tumors

Wasting Syndrome

Cachexia

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Weight Loss

Body Weight Changes

Thinness

Pancreatic Cancer

Neuroendocrine Tumor

Neuroepithelioma

Somatostatin

Treatment of telotristat ethyl (Xermelo) with DXA scans and bionutritional assessments (24-hour food recall and taste/smell alteration) conducted 3x during telotristat ethyl treatment.

250 mg tablets of Xermelo (telotristat ethyl) is administered orally 3x daily in combination with somatostatin analogs (SSAs) for approximately 84 days as per standard of care

Andrew Hendifar, MD, MPH

This single arm study will evaluate whether Xermelo (telotristat ethyl) associated weight gain is affects lean body mass, dietary intake, and physical and cognitive functioning among neuroendocrine tumor (NET) patients with a history of carcinoid syndrome.

The purpose of this study is to examine the mechanisms of weight gain associated with the drug telotristat ethyl (Xermelo) among patients with a neuroendocrine tumor (NET) with history of carcinoid syndrome. We want to know if taking Xermelo affects patients' lean body mass, quality of life, dietary intake, and physical and cognitive functioning during treatment. A better understanding of the mechanisms of weight gain from Xermelo may allow us to determine whether this drug may be beneficial for treating carcinoid syndrome, cachexia, or weight loss seen in other diseases.

Open Label Study to Analyze the Effect of Telotristat Ethyl on Weight Regulation/Gain

IIT2018-26 -Hendifar-NETCx: A Descriptive, Multicenter, Single-arm, Open Label Study to Analyze the Effect of Telotristat Ethyl on Weight Regulation/Gain

The summary score (SS) is a mean of 13 QLQ-C30 subscale scores, ranging from 0 to 100, with a higher SS rating reflecting a better health status.

MOCA scores range between 0 and 30, with higher scores indicating higher cognitive function.

The stool survey is a non-validated descriptive measure of gastrointestinal symptoms by taking the mean score on a scale of 0 - 10, where 0 indicates no symptoms and higher scores denote a worsening of symptoms.

Lexicon Pharmaceuticals

Andrew Hendifar, MD

Assistant Professor of Medicine

Substance Related Disorders

Syndrome

Carcinoid Tumor

Malignant Carcinoid Syndrome

Serotonin Syndrome

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Carcinoid Syndrome

Mitoguazone

Patients receive retifanlimab IV over 30-60 minutes on day 1 and telotristat ethyl PO TID on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Retifanlimab

Telotristat Ethyl

Daniel M Halperin, MD

This phase II trial studies the effect of retifanlimab and telotristat ethyl in treating patients with neuroendocrine tumors that have spread to other places in the body (advanced) and carcinoid syndrome. Retifanlimab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Telotristat ethyl is a drug used to reduce side effects of carcinoid syndrome. Giving retifanlimab and telotristat ethyl may help to control neuroendocrine tumors in patients who also have carcinoid syndrome.

PRIMARY OBJECTIVE:

I. To evaluate the efficacy of retifanlimab (A12) + telotristat ethyl (TE).

SECONDARY OBJECTIVE:

I. To evaluate the efficacy of A12 + TE.

SAFETY OBJECTIVES:

I. To evaluate the safety of A12 + TE. II. To evaluate the safety of withholding concurrent somatostatin analogue in patients receiving A12 + TE.

EXPLORATORY BIOMARKER OBJECTIVE:

I. To identify biomarkers that are predictive of response to A12 + TE (i.e., predictive biomarkers), are associated with progression to a more severe disease state (i.e., prognostic biomarkers), are associated with resistance to A12 + TE, are associated with susceptibility to developing adverse events, can provide evidence of study treatment activity, or can increase the knowledge and understanding of disease biology.

OUTLINE:

Patients receive retifanlimab intravenously (IV) over 30-60 minutes on day 1 and telotristat ethyl orally (PO) 3 times daily (TID) on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years.

Retifanlimab (INCMGA00012) and Telotristat Ethyl for the Treatment of Advanced Neuroendocrine Tumors and Carcinoid Syndrome

A Phase II, Open-Label, Single-Arm Study of INCMGA00012 and Telotristat Ethyl in Patients With Advanced Neuroendocrine Tumors and Carcinoid Syndrome

Will estimate the best response rate and its 95% exact confidence interval using the Clopper and Pearson method.

Will be determined by an independent radiologist according to immune-modified RECIST.

Will be determined by an independent radiologist according to RECIST v1.1. Will be estimated using the Kaplan-Meier method. The log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model may be utilized to include multiple covariates in the time-to-event analysis.

Will be determined by an independent radiologist according to RECIST v1.1.

Will be estimated using the Kaplan-Meier method. The log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model may be utilized to include multiple covariates in the time-to-event analysis.

Will be determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0. Toxicity data will be summarized by frequency tables.

M.D. Anderson Cancer Center

Heart and Blood Diseases

Heart Diseases

Carcinoid Heart Disease

Psychotropic Drugs

Amino Acids

Tryptophan

Lanreotide

Lanreotide 120 mg q4w Telotristat Ethyl 250 mg TID

120 mg Q4W deep subcutaneous injection in the superior external quadrant of the buttock or in the upper outer thigh

Juan Valle

Angela Lamarca

This is a randomized phase III clinical trial of Lanreotide combined with Telotristat ethyl or placebo for the first-line treatment in patients with advanced well differentiated small intestinal neuroendocrine tumours (siNET) with highly-functioning carcinoid syndrome to test whether telotristat ethyl plus lanreotide is more effective than placebo plus lanreotide in reducing the number of daily bowel movements.

In addition, the study allows evaluation of the biochemical response (5-HIAA and chromogranin-A), the reduction in the number of daily cutaneous flushing episodes, the improvement in abdominal pain/discomfort, health-related quality of life, improvement in gastro-intestinal and endocrine symptoms, changes in emotional functioning, the impact of discontinuation of telotristat ethyl/placebo on HRQOL and symptoms, and the safety and toxicity of the treatment.

Patients will enter into a screening/run-in period of 1 week to establish baseline characteristics and symptomatology. The baseline assessment of daily bowel movement, as assessed in an electronic diary, will be averaged over the run-in period.

Following the screening/run-in period, patients will be randomly assigned (1:1) to either the control arm or the experimental arm for 12 months. Randomization will be stratified according to the grade of tumour differentiation (grade 1 vs. grade 2) and by baseline number of bowel movements per day (4-6 versus \>6). A total of 94 patients will be randomly assigned (1:1) to either arm.

Upon randomization, all patients will enter the 12-month treatment period with lanreotide + telotristat ethyl/placebo (blinded). In the experimental arm, patients will receive the deep subcutaneous injection of lanreotide (120 mg) every 28 days and 250 mg orally three times daily (TID) of telotristat ethyl for 12 months. In the control arm, patients will receive the deep subcutaneous injection of lanreotide every 28 days (120 mg) and placebo orally TID for 12 months.

After completion of a minimum of 6 months on randomized blinded-treatment, the protocol allows for patients on treatment with telotristat ethyl/placebo to be unblinded in the event of "lack of symptom control". Unblinding due to "lack of symptom control" can happen at any time between 6 and 12 months of the blinded-treatment period. After unblinding, patient will interrupt protocol treatment and will be further treated as per clinician discretion.

All patients will be unblinded after a maximum of 12 months on randomized blinded-treatment.

After a follow-up of 12 months, patients will go off study except patients with carcinoid heart disease. Patients off study will be further treated as per clinician discretion.

Patients with carcinoid heart disease will continue open-label treatment on study (lanreotide + telotristat ethyl or lanreotide alone according to what they were receiving at unblinding at 12 months) for 4 additional years (open-label extension period). Patients with carcinoid heart disease who discontinue protocol treatment before 12 months will also enter the extension period for additional follow-up. Additional follow-up will last 4 years for these patients and will include 6-monthly cardiological assessments.

All efficacy analyses will be conducted in the Intention-to-treat population as primary analyses i.e. all 94 randomized patients will be analyzed in the arm they were allocated by randomization. Safety analyses will be performed on the Safety population i.e. on all patients who have received at least one dose of the study drugs.

The translational research projects include blood metabolite discovery and targeted assays to find new biomarker candidates of response to Telotristat.

Human biological material that will be collected for translational research purpose:

* whole blood, plasma and serum at baseline, 4 hours after first dose, 4 weeks, 12 weeks and at end of treatment visit with telotristat/placebo (due to end of study, disease progression or lack of benefit)
* archival tissue samples (formalin-fixed paraffin-embedded) will be retrieved for all patients at study entry. In addition, one EDTA blood tube of whole blood (10 ml) at baseline, 12 weeks and end of treatment (EOT visit) might be also collected for not yet pre-defined and further translational research.

Quality of life will be assessed with the EORTC Quality of Life Questionnaire (QLQ-C30) version 3, together with the QLQ-GI.NET21 specific module designed for Neuroendocrine Tumours. The computer-adaptive testing (CAT) diarrhea scale will also be used. The baseline questionnaires must be completed during the screening period and before randomization. Subsequent questionnaires are completed at 4 weeks, 12 weeks, 24 weeks, 36 weeks and 52 weeks. Once a patient has stopped treatment, HRQoL data collection for that patient is required 1 month (28-35 days) after protocol treatment discontinuation.

Lanreotide Combined With Telotristat Ethyl or Placebo for the First-line Treatment in Patients With Advanced Well Differentiated Small Intestinal Neuroendocrine Tumours (siNET) With Highly-functioning Carcinoid Syndrome

Randomized Phase III Clinical Trial of Lanreotide Combined With Telotristat Ethyl or Placebo for the First-line Treatment in Patients With Advanced Well Differentiated Small Intestinal Neuroendocrine Tumours (siNET) With Highly-functioning Carcinoid Syndrome

The change from baseline in the number of bowel movements (BMs) per day

Intrapatient change from baseline in urine/serum/plasma 5-HIAA and chromogranin-A

Change from baseline in the number of daily cutaneous flushing episodes.

Quality of life will be assessed with the EORTC Quality of Life Questionnaire (QLQ-C30) version 3. Scale measures are: not at all; a little; quite a bit; very much.

Ipsen

European Organisation for Research and Treatment of Cancer - EORTC

Patients receive telotristat ethyl PO TID and SSA for 6 months in the absence of disease progression or unacceptable toxicity.

Patients receive placebo PO TID and SSA for 6 months in the absence of disease progression or unacceptable toxicity.

Placebo Administration

Questionnaire Administration

Cezar A. Iliescu, MD

Cezar Iliescu, MD

Cezar A Iliescu, MD

This phase III trial compares the effect of telotristat ethyl and the current standard of care somatostatin analog therapy or somatostatin analog therapy alone in treating patients with neuroendocrine tumor that has spread to other places in the body (metastatic). Telotristat ethyl and somatostatin analog therapy may help to control carcinoid syndrome and carcinoid heart disease.

PRIMARY OBJECTIVE:

I. To estimate the percent change in N-terminal pro B-type natriuretic peptide (NT-proBNP) at 6 month visit from baseline after initiation of study drug in each arm and to compare the percent change between the two study arms.

SECONDARY OBJECTIVES:

I. To evaluate the change in functional capacity from baseline at 3 and 6 month visits as assessed by a 6 minute walk test (6MWT) in each arm.

II. To evaluate changes in echocardiographic parameters (Carcinoid Valvular Heart Disease \[CVHD\] score, global longitudinal myocardial strain assessment of the left and right ventricle/tricuspid annular plane systolic excursion \[TAPSE\]) from baseline to 3 and 6 month visits in each arm.

III. To evaluate the change from baseline to 3 and 6 month visits in plasma 5-hydroxyindoleacetic acid (5-HIAA) levels in each arm.

IV. To evaluate the change from baseline to 3 and 6 month visits in high sensitivity troponin T in each arm.

V. To evaluate the change from baseline to 3 and 6 month visits in health related quality of life with using the MD Anderson Symptom Inventory (MDASI) in each arm.

VI. To evaluate compliance of medications.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive telotristat ethyl orally (PO) three times daily (TID) and somatostatin analog therapy (SSA) for 6 months in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive placebo PO TID and SSA for 6 months in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 30 days.

Telotristat Ethyl for the Treatment of Carcinoid Heart Disease in Patients With Metastatic Neuroendocrine Tumor

TELEHEART: Telotristat Ethyl in a Heart Biomarker Study

Diarrhea

Signs and Symptoms, Digestive

Telotristat ethyl, 250 mg, PO, three times daily, continuous.

+ Peptide Receptor Radionuclide Therapy(PRRT) every 8 weeks

Placebo, PO, three times daily, continuous.

+ Peptide Receptor Radionuclide Therapy(PRRT) every 8 weeks

Telotristat ethyl

Peptide Receptor Radionuclide Therapy

Placebo

Chandrikha Chandrasekharan, MD

Al B Benson, MD

The NET-PACS trial is a Prospective Assessment of patients with neuroendocrine tumors and current or prior history of Carcinoid Syndrome or diarrhea undergoing peptide receptor radionuclide therapy with or without telotristat ethyl. The main goal of the study is to demonstrate the feasibility of serial in-depth assessment of patients with neuroendocrine tumors and current or prior history of carcinoid syndrome or diarrhea undergoing treatment with PRRT using telotristat ethyl compared to placebo. We aim to report and describe from a patient's perspective the multi-faceted impact of carcinoid syndrome in patients with NETs and the changes on treatment while getting PRRT using telotristat ethyl compared to placebo.

Prospective Assessment of Patients With Neuroendocrine Tumors and Current or Prior History of Carcinoid Syndrome or Diarrhea Undergoing Peptide Receptor Radionuclide Therapy With or Without Telotristat Ethyl

Prospective Assessment of Patients With Neuroendocrine Tumors and Current or Prior History of Carcinoid Syndrome or Diarrhea Undergoing Peptide Receptor Radionuclide Therapy With or Without Telotristat Ethyl (NET-PACS Trial) Big Ten Cancer Research Consortium BTCRC-GI19-400

Feasibility of in-depth assessment of changes and improvement on treatment in patients undergoing treatment as determined by FACT-CS global QoL with PRRT using telotristat ethyl compared to placebo. The FACT-CS global QoL is the primary endpoint. Scores will be derived using FACIT guidelines and will range from 0 to 12 with higher scores denoting a better level of functioning.

A repeated measures ANOVA will be applied and statistical significance of fixed effects of treatment arm, time and treatment arm by time interaction will be assessed using a Wilks' Lambda Approximate F test.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Safety and Efficacy Study of XERMELO® + First-line Chemotherapy in Patients With Advanced Biliary Tract Cancer	NCT03790111	Biliary Tract C...	telotristat eth...	18 Years -	TerSera Therapeutics LLC
Open Label Study to Analyze the Effect of Telotristat Ethyl on Weight Regulation/Gain	NCT04034745	Pancreatic Canc... Neuroendocrine ... Cachexia; Cance...	telotristat eth...	18 Years -	Cedars-Sinai Medical Center
Retifanlimab (INCMGA00012) and Telotristat Ethyl for the Treatment of Advanced Neuroendocrine Tumors and Carcinoid Syndrome	NCT04776876	Advanced Neuroe... Carcinoid Syndr...	Retifanlimab Telotristat Eth...	18 Years -	M.D. Anderson Cancer Center
Lanreotide Combined With Telotristat Ethyl or Placebo for the First-line Treatment in Patients With Advanced Well Differentiated Small Intestinal Neuroendocrine Tumours (siNET) With Highly-functioning Carcinoid Syndrome	NCT04065165	Small Intestina... Carcinoid Heart...	Telotristat Eth... Lanreotide	18 Years -	European Organisation for Research and Treatment of Cancer - EORTC
Telotristat Ethyl for the Treatment of Carcinoid Heart Disease in Patients With Metastatic Neuroendocrine Tumor	NCT04810091	Locally Advance... Metastatic Neur...	Placebo Adminis... Questionnaire A... Telotristat Eth...	18 Years -	M.D. Anderson Cancer Center
Prospective Assessment of Patients With Neuroendocrine Tumors and Current or Prior History of Carcinoid Syndrome or Diarrhea Undergoing Peptide Receptor Radionuclide Therapy With or Without Telotristat Ethyl	NCT04713202	Neuroendocrine ... Carcinoid Syndr... Diarrhea	Telotristat eth... Peptide Recepto... Placebo	18 Years -	Big Ten Cancer Research Consortium

Spots Global Cancer Trial Database for telotristat ethyl