Telotristat With Lutathera in Neuroendocrine Tumors
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- STATUS
- Recruiting
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- End date
- Jun 30, 2034
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- participants needed
- 70
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- sponsor
- Aman Chauhan
Summary
This trial will test the hypothesis that Telotristat treatment increases the antitumor efficacy of Lutetium Lu 177 Dotatate therapy in neuroendocrine tumors (NETs).
Description
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.
Details
| Condition | neuroendocrine tumors, neuroendocrine tumour, Neuroectodermal Tumor, Neurectoderma, Neuroendocrine Tumor |
|---|---|
| Treatment | Telotristat (Low-Dose), Telotristat (High-Dose) |
| Clinical Study Identifier | NCT04543955 |
| Sponsor | Aman Chauhan |
| Last Modified on | 10 October 2021 |
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