Open Label Study to Analyze the Effect of Telotristat Ethyl on Weight Regulation/Gain

NCT ID: NCT04034745

Last Updated: 2020-12-30

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-31
• Study Completion Date: 2023-11-30

Brief Summary

This single arm study will evaluate whether Xermelo (telotristat ethyl) associated weight gain is affects lean body mass, dietary intake, and physical and cognitive functioning among neuroendocrine tumor (NET) patients with a history of carcinoid syndrome.

Detailed Description

The purpose of this study is to examine the mechanisms of weight gain associated with the drug telotristat ethyl (Xermelo) among patients with a neuroendocrine tumor (NET) with history of carcinoid syndrome. We want to know if taking Xermelo affects patients' lean body mass, quality of life, dietary intake, and physical and cognitive functioning during treatment. A better understanding of the mechanisms of weight gain from Xermelo may allow us to determine whether this drug may be beneficial for treating carcinoid syndrome, cachexia, or weight loss seen in other diseases.

Conditions

Pancreatic Cancer; Neuroendocrine Tumors; Cachexia; Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Standard of Care telotristat ethyl (Xermelo) Treatment

Treatment of telotristat ethyl (Xermelo) with DXA scans and bionutritional assessments (24-hour food recall and taste/smell alteration) conducted 3x during telotristat ethyl treatment.

telotristat ethyl

Intervention Type: DRUG

250 mg tablets of Xermelo (telotristat ethyl) is administered orally 3x daily in combination with somatostatin analogs (SSAs) for approximately 84 days as per standard of care

Interventions

telotristat ethyl

250 mg tablets of Xermelo (telotristat ethyl) is administered orally 3x daily in combination with somatostatin analogs (SSAs) for approximately 84 days as per standard of care

Intervention Type: DRUG

Other Intervention Names

Xermelo

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years.
• Histopathologically confirmed diagnosis of a metastatic NET.
• Documented history of carcinoid syndrome.
• Currently receiving treatment with long-acting SSAs with a plan to initiate therapy with telotristat-ethyl as per standard of care.
• ECOG performance status 0-1 and/or Karnofsky >60%.
• Greater than or equal to 3 month life expectancy.
• Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria

• Patients experiencing more than 12 watery BMs per day associated with volume contraction, dehydration, or hypotension, or showing evidence of enteric infection.
• History of short bowel syndrome.
• Clinically important baseline elevation in liver function tests.
• Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
• Malignant ascites requiring paracenteses.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Bowel obstruction, partial, or total.
• Pregnancy
• Patients with unresolved grade 3/4 adverse effects of prior therapy at time of enrollment, other than diarrhea

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lexicon Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Andrew Hendifar, MD

OTHER

Sponsor Role: lead

Responsible Party

Andrew Hendifar, MD

Assistant Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Andrew Hendifar, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Other Identifiers

IIT2018-26 -Hendifar-NETCx

Identifier Type: -

Identifier Source: org_study_id