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

NCT04034745 | Withdrawn

• 1 other identifier: IIT2018-26 -Hendifar-NETCx
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pancreatic Cancer; Neuroendocrine Tumors; Cachexia; Cancer

Outcome Measures

Primary Outcomes (1)

• Mean change in lean body mass (measured using DXA Scan) from baseline and after 13 weeks of treatment.

  From baseline to 13 weeks after treatment

Secondary Outcomes (9)

• Mean change in patient reported outcomes using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) from baseline up to 3 years post treatment.

  From baseline to 3 years post treatment

• Mean change in patient reported outcomes using the Montreal Cognitive Assessment (MOCA) test from baseline up to 3 years post treatment.

  From baseline to 3 years post treatment

• Mean change in patient reported outcomes using a stool survey measured from baseline and after 13 weeks of treatment.

  From baseline to 13 weeks post-treatment.

• Mean change in calories consumed using a 24-hour food diary from baseline and after 13 weeks of treatment.

  From baseline to 13 weeks post-treatment

• Mean change in daily activity levels (steps) as measured using a wrist-worn fitness tracker (e.g., Fitbit) from baseline and for the duration of the 13 weeks of treatment.

  From baseline to 13 weeks post-treatment

Study Arms (1)

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.

Drug: telotristat ethyl

Interventions

telotristat ethyl 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

Also known as: Xermelo

Standard of Care telotristat ethyl (Xermelo) Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from Cedars-Sinai Medical Center

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Andrew Hendifar, MD: lead
• Lexicon Pharmaceuticals: collaborator

MeSH Terms

Conditions

Pancreatic Neoplasms; Neuroendocrine Tumors; Cachexia; Neoplasms

Interventions

telotristat ethyl

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Study Officials

• Andrew Hendifar, MD, MPH

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: June 29, 2019
• First Posted: July 26, 2019
• Study Start: October 1, 2020
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2023
• Last Updated: December 30, 2020

Record last verified: 2020-12