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Malignant Carcinoid Syndrome clinical trials

View clinical trials related to Malignant Carcinoid Syndrome.

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NCT ID: NCT04065165 Withdrawn - Clinical trials for Carcinoid Heart Disease

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

TELEFIRST
Start date: April 2020
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT04039516 Not yet recruiting - Carcinoid Tumor Clinical Trials

Carcinoid Heart Disease and Peptide Receptor Radiotargetted Therapy

CHARRT
Start date: October 2020
Phase: Phase 2
Study type: Interventional

Randomised trial to assess progression of carcinoid heart disease in patients treated with Lutathera therapy compared to best supportive care.

NCT ID: NCT03722511 Completed - Diarrhea Clinical Trials

Evaluating an Amino Acid Based Medical Food w/ Diarrhea in Carcinoid Syndrome & Other NETs

Start date: December 6, 2018
Phase: Phase 2
Study type: Interventional

Primary Objective: To assess how an amino acid based medical food (Enterade®) helps maintain the intestine's ability to absorb and retain fluids, leading to a reduction in diarrhea due to Neuroendocrine Tumors (NET) and/or Carcinoid Syndrome. This improvement in the absorption will be assessed in part by evaluating changes in average daily stool frequency from baseline in patients receiving Enterade®. Each subject serves as his or her own control. Secondary Objectives: - To assess subject reported health-related quality of life in subjects before and after compound administration. - To characterize the side effect profile and tolerability of Enterade® as measured by the number of total 8-oz Enterade® bottles consumed throughout the trial, and average drinks per day. - To evaluate changes in serum electrolytes before and after administration of Eenterade®. - To assess intravenous fluid requirement and/or hospitalization for dehydration secondary to diarrhea between control observation period and active Enterade® period. - To evaluate difference in utilization of standard-of-care anti-diarrheal medications between control observation period and Enterade® period. - To compare subjective feeling of bloating and flatulence before and after administration of Enterade®. - To evaluate changes in patient weight before and after administration of Enterade®.

NCT ID: NCT03453489 Recruiting - Carcinoid Syndrome Clinical Trials

AMT-PET in Monitoring Telotristat Etiprate Treatment in Participants With MetastaticNeuroendocrine Neoplasm

Start date: June 20, 2018
Phase: Phase 2
Study type: Interventional

This pilot trial studies how well telotristat etiprate works in treating participants with well differentiated neuroendocrine neoplasm that has spread to other places in the body and monitored by carbon C 11 alpha-methyltryptophan (AMT)-emission tomography (PET). Telotristat etiprate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Studying the changes within the tumor cells via AMT-PET may help doctors better understand how tumors respond to treatment with telotristat etiprate.

NCT ID: NCT03375320 Active, not recruiting - Carcinoid Tumor Clinical Trials

Testing Cabozantinib in Patients With Advanced Pancreatic Neuroendocrine and Carcinoid Tumors

Start date: October 26, 2018
Phase: Phase 3
Study type: Interventional

This phase III trial studies cabozantinib to see how well it works compared with placebo in treating patients with neuroendocrine or carcinoid tumors that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Cabozantinib is a chemotherapy drug known as a tyrosine kinase inhibitor, and it targets specific tyrosine kinase receptors, that when blocked, may slow tumor growth.

NCT ID: NCT03223428 Completed - Carcinoid Syndrome Clinical Trials

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

RELAX
Start date: June 22, 2017
Phase:
Study type: Observational [Patient Registry]

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).

NCT ID: NCT03220087 Completed - Clinical trials for Neuroendocrine Tumors

Study to Evaluate the Use of Resources and the Costs Associated With Carcinoid Syndrome (CS) in Patients With NETs in Spain

RECOSY
Start date: July 21, 2017
Phase:
Study type: Observational

The objective of this study is to describe the use of resources and the costs associated with controlled or uncontrolled CS in patients with NETs in Spain.

NCT ID: NCT02259725 Completed - Insulinoma Clinical Trials

Regorafenib in Treating Patients With Advanced or Metastatic Neuroendocrine Tumors

Start date: August 16, 2016
Phase: Phase 2
Study type: Interventional

This phase II trial studies regorafenib in treating patients with neuroendocrine tumors that have spread from the primary site (place where it started) to other places in the body. Regorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

NCT ID: NCT02063659 Completed - Carcinoid Syndrome Clinical Trials

Telotristat Etiprate for Carcinoid Syndrome Therapy

TELECAST
Start date: March 11, 2014
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the effect of telotristat etiprate versus placebo on the incidence of treatment-emergent adverse events and on 5-hydroxyindoleacetic acid (5-HIAA) levels.

NCT ID: NCT02026063 Completed - Carcinoid Syndrome Clinical Trials

Telotristat Etiprate - Expanded Treatment for Patients With Carcinoid Syndrome Symptoms

TELEPATH
Start date: January 14, 2014
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the long-term safety and tolerability of orally administered telotristat etiprate.