Telotristat Ethyl for the Treatment of Carcinoid Heart Disease in Patients With Metastatic Neuroe… (NCT04810091) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Telotristat Ethyl for the Treatment of Carcinoid Heart Disease in Patients With Metastatic Neuroendocrine Tumor
United States79 participantsStarted 2021-05-18
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients who are \>= 18 years old will be eligible for the study
* Histopathologically-confirmed,metastatic neuroendocrine tumor and/or locally/regionally advanced neuroendocrine tumor
* Documented history of carcinoid syndrome based on clinical parameters
* Currently receiving stable-dose somatostatin analog (SSA) therapy defined as \>= 2 months
* Dose of long-acting release (LAR) or depot SSA therapy and on at least:
* Octreotide LAR at 30 mg every 4 weeks
* Lanreotide depot at 120 mg every 4 weeks
* Patients who cannot tolerate SSA therapy at a level indicated above will be allowed to enter at their highest tolerated dose
* Ability and willingness to provide written informed consent
* Patients of childbearing potential must agree to use an adequate method of contraception during the study and for 30 days after the last dose of telotristat ethyl
* Childbearing potential is defined as those who have not undergone surgical sterilization (eg. documented hysterectomy, tubal ligation, or bilateral salpingo-oophorectomy) or those who are not considered postmenopausal (defined as 12 months of spontaneous amenorrhea).
* 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…
What they're measuring
1
Percent Change in NTproBNP at 6 Months Visit From Baseline