Telotristat With Lutathera in Neuroendocrine Tumors
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|ClinicalTrials.gov Identifier: NCT04543955|
Recruitment Status : Recruiting
First Posted : September 10, 2020
Last Update Posted : October 5, 2021
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumors||Drug: Telotristat (Low-Dose) Drug: Telotristat (High-Dose)||Phase 2|
Neuroendocrine tumors (NETs) are a very heterogeneous group of tumors that develop predominantly in the gastrointestinal and pulmonary systems. Clinical detection and diagnosis are more reliable at late stages when metastatic spread has occurred. Patients with advanced disease may suffer from complications of uncontrolled hormone secretion and usually succumb due to tumor progression.
This trial tests the hypothesis that inhibition of serotonin production with Telotristat will lead to cytostatic effects on neuroendocrine tumors and will complement the anti-tumor activity of Lutetium 177 Dotatate. The proposed combination may result in improved treatment efficacy as reflected by improved 20-month progression-free survival (PFS) as compared to historical control.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of Telotristat (Xermelo) in Combination With Luetetium Lu177 Dotatate (Lutathera) in Well-Differentiated Neuroendocrine Tumors|
|Actual Study Start Date :||July 19, 2021|
|Estimated Primary Completion Date :||June 30, 2034|
|Estimated Study Completion Date :||June 30, 2034|
Experimental: Arm 1: Low-Dose Telotristat
Participants in this group will receive 750mg Telotristat per day.
Drug: Telotristat (Low-Dose)
Participants in this group will receive Lutetium Lu 177 Dotate (Lutathera) by IV every 2 months (Q8weeks) for a total of 4 doses. They will also receive oral Telotristat at 750mg per day (250mg TID) for 20 months.
Other Name: Xermelo
Experimental: Arm 2: High-Dose Telotristat
Participants in this group will receive 1500mg Telotristat per day.
Drug: Telotristat (High-Dose)
Participants in this group will receive Lutetium Lu 177 Dotate (Lutathera) by IV every 2 months (Q8weeks) for a total of 4 doses. They will also receive oral Telotristat at 1500mg per day (500mg TID) for 20 months.
Other Name: Xermelo
- Progression-Free Survival (PFS) [ Time Frame: 20 months ]Progression-free survival at 20 months.
- Overall Response Rate (ORR) [ Time Frame: 6 and 12 months ]Overall response rate using RECIST v1.1 at 6 and 12 months after therapy
- Median Progression-Free Survival (PFS) [ Time Frame: 36 month ]Median progression-free survival.
- Urinary 5-HIAA [ Time Frame: Baseline and 12 months ]Levels of urinary 5-Hydroxyindoleacetic acid (5-HIAA) will be measured at baseline and 12 months.
- Quality of Life (QLQ-C30) [ Time Frame: 20 month ]The Quality of Life Questionnaire C30 (QLQ-C30) was developed by the European Organization for Research and Treatment of Cancer (EORTC) to assess quality of life in cancer patients.It includes five function domains (physical, emotional, social, role, cognitive), eight symptoms (fatigue, pain, nausea/vomiting, constipation, diarrhea, insomnia, dyspnea, and appetite loss), as well as global health/quality-of-life and financial impact. Subjects respond on a four-point scale from "not at all" to "very much" for most items.Raw scores are linearly converted to a 0-100 scale with higher scores reflecting higher levels of function and higher levels of symptom burden.
- Quality of Life (QLQ-GI.NET21) [ Time Frame: 20 month ]The Quality of Life GI Neuroendocrine Tumor survey (QLQ-GINET21) contains a total of 21 items: four single-item assessments relating to muscle and/or bone pain (MBP), body image (BI), information (INF) and sexual functioning (SX), together with 17 items organised into five proposed scales: endocrine symptoms (ED; three items), GI symptoms (GI; five items), treatment-related symptoms (TR; three items), social functioning (SF) and disease-related worries (DRW; three items). The response format of the questionnaire is a four-point Likert scale. Responses are linearly transformed to a 0-100 scale using EORTC guidelines, with higher scores reflecting more severe symptoms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04543955
|Contact: Aman Chauhan, MDfirstname.lastname@example.org|
|United States, Kentucky|
|Markey Cancer Center||Recruiting|
|Lexington, Kentucky, United States, 40536|
|Contact: Aman Chauhan, MD email@example.com|
|Principal Investigator: Aman Chauhan, MD|
|Principal Investigator:||Aman Chauhan, MD||University of Kentucky|