Pancreatic CancerNCT04034745
Open Label Study to Analyze the Effect of Telotristat Ethyl on Weight Regulation/Gain
An observational study of Pancreatic Cancer and Neuroendocrine Tumors, run by Andrew Hendifar, MD.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Neuroendocrine Tumors, Cachexia; Cancer
- What is being tested?
- telotristat ethyl
- Type of treatment
- Pill or oral medicine
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2020to Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited from Cedars-Sinai Medical Center
Who may be able to join
- 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.
Who cannot join
- 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.
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- Bowel obstruction, partial, or total.
- Pregnancy
- Patients with unresolved grade 3/4 adverse effects of prior therapy at time of enrollment, other than diarrhea
About this study
Official title: IIT2018-26 -Hendifar-NETCx: A Descriptive, Multicenter, Single-arm, Open Label Study to Analyze the Effect of Telotristat Ethyl on Weight Regulation/Gain
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.
Read the 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
- Being tested
- telotristat ethyl
- Medical subject headings
- Pancreatic Neoplasms, Neuroendocrine Tumors, Cachexia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telotristat ethylDrug
Also called Xermelo
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: telotristat ethyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in lean body mass (measured using DXA Scan) from baseline and after 13 weeks of treatment.
Measured: 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.
The summary score (SS) is a mean of 13 QLQ-C30 subscale scores, ranging from 0 to 100, with a higher SS rating reflecting a better health status.
Measured: 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.
MOCA scores range between 0 and 30, with higher scores indicating higher cognitive function.
Measured: 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.
The stool survey is a non-validated descriptive measure of gastrointestinal symptoms by taking the mean score on a scale of 0 - 10, where 0 indicates no symptoms and higher scores denote a worsening of symptoms.
Measured: 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.
Measured: 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.
Measured: From baseline to 13 weeks post-treatment
Mean change in daily activity levels [stairs (floors) climbed] as measured using a wrist-worn fitness tracker (e.g., Fitbit) from baseline and for the duration of the 13 weeks of treatment.
Measured: From baseline to 13 weeks post-treatment
Mean change in daily activity levels (sleep duration) as measured using a wrist-worn fitness tracker (e.g., Fitbit) from baseline and for the duration of the 13 weeks of treatment.
Measured: From baseline to 13 weeks post-treatment
Mean change in daily activity levels (heart rate) as measured using a wrist-worn fitness tracker (e.g., Fitbit) from baseline and for the duration of the 13 weeks of treatment.
Measured: From baseline to 13 weeks post-treatment
Mean change in daily activity levels (active minutes) as measured using a wrist-worn fitness tracker (e.g., Fitbit) from baseline and for the duration of the 13 weeks of treatment.
Measured: From baseline to 13 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study startOct 2020 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionNov 2023 (estimated)
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrew Hendifar, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Lexicon Pharmaceuticals
- Responsible party
- Sponsor-investigator, Andrew Hendifar, MD, Cedars-Sinai Medical Center
- Investigators
- Andrew Hendifar, MD, MPH, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04034745
- Sponsor's protocol ID
- IIT2018-26 -Hendifar-NETCx
- Status last verified
- Dec 2020
- First submitted
- 29 Jun 2019
- Last updated
- 30 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IIT2018-26 -Hendifar-NETCx: A Descriptive, Multicenter, Single-arm, Open Label Study to Analyze the Effect of Telotristat Ethyl on Weight Regulation/Gain
- ClinicalTrials.gov ID
- NCT04034745
- Acronym / sponsor ID
- IIT2018-26 -Hendifar-NETCx
- Conditions
- Pancreatic Cancer, Neuroendocrine Tumors, Cachexia; Cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Andrew Hendifar, MDUniversity, hospital or other
- Collaborators
- Lexicon Pharmaceuticals
- Study start
- Oct 2020 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 26 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard of Care telotristat ethyl (Xermelo) Treatment | – | Drug: telotristat ethylTreatment of telotristat ethyl (Xermelo) with DXA scans and bionutritional assessments (24-hour food recall and taste/smell alteration) conducted 3x during telotristat ethyl treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from Cedars-Sinai Medical Center
Key inclusion criteria (7 listed)
- 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%.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| telotristat ethylAlso: Xermelo250 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 | Drug | Standard of Care telotristat ethyl (Xermelo) Treatment |
Primary outcome
Mean change in lean body mass (measured using DXA Scan) from baseline and after 13 weeks of treatment.
Time frame: From baseline to 13 weeks after treatment
9 secondary outcomes
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From baseline to 13 weeks post-treatment
Mean change in daily activity levels [stairs (floors) climbed] as measured using a wrist-worn fitness tracker (e.g., Fitbit) from baseline and for the duration of the 13 weeks of treatment.
Time frame: From baseline to 13 weeks post-treatment
Mean change in daily activity levels (sleep duration) as measured using a wrist-worn fitness tracker (e.g., Fitbit) from baseline and for the duration of the 13 weeks of treatment.
Time frame: From baseline to 13 weeks post-treatment
Mean change in daily activity levels (heart rate) as measured using a wrist-worn fitness tracker (e.g., Fitbit) from baseline and for the duration of the 13 weeks of treatment.
Time frame: From baseline to 13 weeks post-treatment
Mean change in daily activity levels (active minutes) as measured using a wrist-worn fitness tracker (e.g., Fitbit) from baseline and for the duration of the 13 weeks of treatment.
Time frame: From baseline to 13 weeks post-treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Hendifar, MD, MPH principal investigator
Cedars-Sinai Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer and Neuroendocrine Tumors, run by Andrew Hendifar, MD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in lean body mass (measured using DXA Scan) from baseline and after 13 weeks of treatment. (time frame: From baseline to 13 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2020; AzTrials last refreshed its copy on 6 Nov 2026.