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Also known as Xermelo
Telotristat ethyl · 2 trials · 6 indications
Weight stability will be documented as percent weight change at 3 months compared to baseline.
| Arm | Type | Description |
|---|---|---|
| Group 1 (gemcitabine/nab-paclitaxel and telotristat ethyl) | EXPERIMENTAL | Patients receive gemcitabine/nab-paclitaxel combination chemotherapy on days 1, 8 and 15, and telotristat ethyl PO QD, BID, or TID on days 1 and 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
| Group 2 (gemcitabine/nab-paclitaxel) | ACTIVE_COMPARATOR | Patients receive gemcitabine/nab-paclitaxel chemotherapy (at the discretion of the investigator) on days 1, 8 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
| Severe Hepatic Impairment | EXPERIMENTAL | Up to 8 subjects with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15 points) |
| Healthy Control | EXPERIMENTAL | Up to 8 healthy control subjects with normal hepatic function |
| Name | Type | Description |
|---|---|---|
| Gemcitabine | DRUG | Given gemcitabine/nab-paclitaxel combination therapy |
| Nab-paclitaxel | DRUG | Given gemcitabine/nab-paclitaxel combination therapy |
| Telotristat Ethyl | DRUG | Given PO |
Inclusion Criteria: * GROUP 1 (Telotristat ethyl treatment group): Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separat...
Telotristat ethyl is a small molecule drug developed by Lexicon Pharmaceuticals, Inc. (ticker LXRX). It is being studied in hepatic impairment and in locally advanced unresectable pancreatic adenocarcinoma. It is also known as telotristat ethyl 250 mg. It is an investigational agent in clinical development and is not described as approved.
Telotristat ethyl targets tryptophan hydroxylase 2 (TPH2) and tryptophan hydroxylase 1 (TPH1). It acts as an inhibitor of these enzymes. TPH1 and TPH2 are involved in serotonin synthesis, and inhibiting them reduces serotonin production.
Telotristat ethyl is developed by Lexicon Pharmaceuticals, Inc., which trades under the ticker LXRX. Lexicon is the company associated with the clinical development program for this small molecule in hepatic impairment and pancreatic adenocarcinoma.
Telotristat ethyl is in Phase 1 development according to its current development stage. It is an investigational drug and is not described as FDA approved. The program includes completed trials at both Phase 1 and Phase 2, with no active trials currently listed.
Telotristat ethyl has been studied in two completed trials. NCT03910387 was a Phase 2 study of telotristat ethyl to promote weight stability in patients with advanced stage pancreatic cancer, enrolling 23 participants in the United States. NCT03423446 was a Phase 1 pharmacokinetic study in subjects with severe hepatic impairment, enrolling 16 participants.