Locally Advanced Unresectable Pancreatic AdenocarcinomaPhase 2NCT03910387
Telotristat Ethyl to Promote Weight Stability in Patients With Advanced Stage Pancreatic Cancer
A Phase 2 study testing Gemcitabine, Nab-paclitaxel and Telotristat Ethyl in people with Locally Advanced Unresectable Pancreatic Adenocarcinoma and Metastatic Pancreatic Adenocarcinoma, run by Emory University at 3 sites in United States.
Trial summary
This phase II trial studies how well telotristat ethyl works in promoting weight stability in patients with pancreatic adenocarcinoma that has come back and spread to other places in the body. Telotristat ethyl may decrease bowel movements which may make patients gain weight. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Unresectable Pancreatic Adenocarcinoma, Metastatic Pancreatic Adenocarcinoma, Recurrent Pancreatic Adenocarcinoma
- What is being tested?
- Gemcitabine, Nab-paclitaxel and Telotristat Ethyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 Apr 2019to 29 Jun 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- 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 separately.
- GROUP 1 (Telotristat ethyl treatment group): Weight loss of 10% or more.
- GROUP 1 (Telotristat ethyl treatment group): Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 within 14 days prior to registration.
- GROUP 1 (Telotristat ethyl treatment group): Histologic or cytological diagnosis of recurrent or metastatic pancreas adenocarcinoma (PDAC) who present for first line chemotherapy treatment for metastatic disease.
- GROUP 1 (Telotristat ethyl treatment group): Advanced stage pancreas cancer (recurrent/metastatic).
- GROUP 1 (Telotristat ethyl treatment group): Measurable disease determined using guidelines of Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Baseline tumor assessment should be performed using high resolution computed tomography (CT) scans or magnetic resonance imaging (MRI).
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- GROUP 1 (Telotristat ethyl treatment group): Prior systemic therapy (adjuvant or neoadjuvant setting are acceptable) if disease progressed or recurred within at least 3 months after treatment.
- GROUP 1 (Telotristat ethyl treatment group): Estimated life expectancy of > 12 weeks, as assessed by the site investigator.
- GROUP 1 (Telotristat ethyl treatment group): If sexually active, must be postmenopausal, surgically sterile, or using effective contraception (hormonal or barrier methods) due to unknown risk of teratogenicity.
- GROUP 1 (Telotristat ethyl treatment group): Hemoglobin ≥ 8 g/dL (obtained within 7 days prior to registration).
- GROUP 1 (Telotristat ethyl treatment group): Absolute Neutrophil Count (ANC) ≥ 1,500/mm³ (obtained within 7 days prior to registration).
- GROUP 1 (Telotristat ethyl treatment group): Platelet Count (PLT) ≥ 100,000/mm³ (obtained within 7 days prior to registration).
- GROUP 1 (Telotristat ethyl treatment group): Creatinine ≤ 1.5 mg/dL (obtained within 7 days prior to registration).
- GROUP 1 (Telotristat ethyl treatment group): Albumin ≥ 2 g/dL (obtained within 7 days prior to registration).
- GROUP 1 (Telotristat ethyl treatment group): Bilirubin ≤ 1.5 mg/dL (obtained within 7 days prior to registration).
- GROUP 1 (Telotristat ethyl treatment group): Aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN) or < 5 x ULN in the setting of liver metastases (obtained within 7 days prior to registration).
- GROUP 1 (Telotristat ethyl treatment group): Alanine aminotransferase (ALT) ≤ 3 x ULN or < 5 x ULN in the setting of liver metastases (obtained within 7 days prior to registration).
- GROUP 1 (Telotristat ethyl treatment group): Prior radiation is allowed if happened more than 2 weeks of enrollment.
- GROUP 2 (Non-Telotristat ethyl group): Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- GROUP 2 (Non-Telotristat ethyl group): Stable weight or loss of < 10% by history.
- GROUP 2 (Non-Telotristat ethyl group): ECOG Performance Status of 0-2 within 14 days prior to registration.
- GROUP 2 (Non-Telotristat ethyl group): Histologic or cytological diagnosis of locally advanced unresectable, recurrent/metastatic PDAC who present for first line chemotherapy treatment for metastatic disease.
- GROUP 2 (Non-Telotristat ethyl group): Advanced stage PDAC (locally advanced unresectable/recurrent/metastatic).
- GROUP 2 (Non-Telotristat ethyl group): Prior systemic therapy (adjuvant or neoadjuvant setting are acceptable) if disease progressed or recurred within at least 3 months after treatment.
- GROUP 2 (Non-Telotristat ethyl group): Estimated life expectancy of > 12 weeks, as assessed by the site investigator.
- GROUP 2 (Non-Telotristat ethyl group): Prior radiation is allowed if happened more than 2 weeks of enrollment.
Who cannot join
- GROUP 1 (Telotristat ethyl treatment group): Subjects with histology other than adenocarcinoma. Examples include: neuroendocrine tumors, acinar cell cancer, sarcoma or lymphoma of the pancreas.
- GROUP 1 (Telotristat ethyl treatment group): Ongoing or active infection.
- GROUP 1 (Telotristat ethyl treatment group): Symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia. Symptomatic heart failure (New York Heart Association [NYHA] Class II-IV).
- GROUP 1 (Telotristat ethyl treatment group): Acute or sub-acute intestinal obstruction.
- GROUP 1 (Telotristat ethyl treatment group): Ascites.
- GROUP 1 (Telotristat ethyl treatment group): Documented and/or symptomatic or known brain or leptomeningeal metastases.
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- GROUP 1 (Telotristat ethyl treatment group): Severely immune-compromised (other than being on steroids) including known human immunodeficiency virus (HIV) infection.
- GROUP 1 (Telotristat ethyl treatment group): Concurrent active malignancy, other than adequately treated non-melanoma skin cancer, other noninvasive carcinoma, or in situ neoplasm. A subject with previous history of malignancy is eligible if he/she has been disease-free for > 3 years.
- GROUP 1 (Telotristat ethyl treatment group): Breast-feeding or pregnant. Serum pregnancy test for women of child-bearing potential must be performed within 7 days prior to first dose of study treatment.
- GROUP 1 (Telotristat ethyl treatment group): Prior autologous or allogeneic organ or tissue transplantation.
- GROUP 1 (Telotristat ethyl treatment group): Known allergy to any of the treatment components.
- GROUP 1 (Telotristat ethyl treatment group): Have any condition that does not permit compliance with the study schedule including psychological, geographical, or medical.
- GROUP 1 (Telotristat ethyl treatment group): Not able to swallow. Inability to take oral medications.
- GROUP 1 (Telotristat ethyl treatment group): Patients with chronic constipation.
- GROUP 2 (Non-Telotristat ethyl group): Subjects with histology other than adenocarcinoma. Examples include: neuroendocrine tumors, acinar cell cancer, sarcoma or lymphoma of the pancreas.
- GROUP 2 (Non-Telotristat ethyl group): Ongoing or active infection.
- GROUP 2 (Non-Telotristat ethyl group): Symptomatic congestive heart failure, unstable angina or arrhythmia. Symptomatic heart failure (NYHA Class II-IV).
- GROUP 2 (Non-Telotristat ethyl group): Acute or sub-acute intestinal obstruction.
- GROUP 2 (Non-Telotristat ethyl group): Severely immune-compromised (other than being on steroids) including known HIV infection.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
About this study
Official title: Weight Loss in Patients With Advanced Stage Pancreatic Cancer: Role of Serotonin and Effects of Telotristat Ethyl
This phase II trial studies how well telotristat ethyl works in promoting weight stability in patients with pancreatic adenocarcinoma that has come back and spread to other places in the body. Telotristat ethyl may decrease bowel movements which may make patients gain weight. Stabilizing weight may help patients tolerate chemotherapy better and improve longevity.
Read the detailed description
PRIMARY OBJECTIVES:
- Evaluate weight stability after 3 months of telotristat ethyl treatment in patients who have significant weight loss (documented to be more than or equal to 10%) prior to the start of treatment. (Group 1).
II. Evaluate the change in serum and 24-hours (hr) urine 5-hydroxyindoleacetic acid (5-HIAA) in patients with locally advanced unresectable, recurrent or metastatic pancreatic adenocarcinoma (PDAC) receiving chemotherapy. (Group 2).
SECONDARY OBJECTIVES:
- Evaluate the impact of weight stabilization/gain on patients in Group 1 on performance status, quality of life (QOL), mid arm circumference (MAC) and muscle mass on cross sectional imaging.
II. Evaluate correlations between changes in serotonin/ 5HIAA levels on radiologic response, weight stability, mid arm circumference (MAC), and muscle mass on cross sectional imaging.
III. Evaluate the relation of baseline serum and 24-hr urine 5-HIAA on weight loss in patients with advanced PDAC.
IV. Safety and tolerability of telotristat ethyl with gemcitabine/nab-paclitaxel combination chemotherapy.
- Evaluate response rate (RR) assessed per Response Evaluation Criteria in Solid Tumors (RECIST), progression free survival and overall survival in patients receiving telotristat ethyl (Group 1).
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP 1: Patients receive gemcitabine/nab-paclitaxel combination chemotherapy on days 1, 8 and 15, and telotristat ethyl orally (PO) once daily (QD), twice daily (BID), or thrice daily (TID) on days 1 and 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
GROUP 2: Patients receive 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.
After completion of study treatment, patients are followed up at 30 days, then every 8 weeks thereafter.
- Conditions
- Locally Advanced Unresectable Pancreatic Adenocarcinoma, Metastatic Pancreatic Adenocarcinoma, Recurrent Pancreatic Adenocarcinoma, Stage III Pancreatic Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8
- Being tested
- Gemcitabine, Nab-paclitaxel, Telotristat Ethyl
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Also called Gemzar, dFdCyd, Difluorodeoxycytidine
Given gemcitabine/nab-paclitaxel combination therapy
Nab-paclitaxelDrug
Also called ABI-007, Abraxane, Nanoparticle Albumin-bound Paclitaxel
Given gemcitabine/nab-paclitaxel combination therapy
Telotristat EthylDrug
Also called Xermelo
Given PO
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Gemcitabine; Drug: Nab-paclitaxel; Drug: Telotristat Ethyl |
| 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. Receives: Drug: Gemcitabine; Drug: Nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Stability
Weight stability will be documented as percent weight change at 3 months compared to baseline.
Measured: Baseline up to 3 months after study start
Secondary outcomes (7)
Change in 24-hr Urine 5-hydroxyindoleacetic Acid (5-HIAA) Levels
The change will be summarized as mean and standard deviation.
Measured: Baseline up to 4 months after study start
Mid Arm Circumference (MAC) Measured in cm
Mid arm circumference (MAC) will be reviewed on cross sectional imaging and will be assessed with imaging guided measurements of the psoas and rectus abdominis muscle.
Measured: Up to 2 years after study start
Quality of Life (QOL)
Quality of life (QOL) will be assessed by the Obesity Related Quality of Life (OWL-QOL)-17 questionnaire.
*Please note OC Measure was not collected.
Measured: Up to 2 years after study start
Blood Serotonin Levels
Blood serotonin levels will be compared in the 2 groups.
Measured: Up to 2 years after study start
Response Rate (RR)
Response rate (RR) will be assessed per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, in patients receiving telotristat ethyl (Group 1).
Measured: Up to 2 years after study start
Median Overall Survival (MOS)
Median overall survival (MOS) will be measured using the Kaplan-Meier method.
Measured: Up to 2 years after study start
Duration of Response
Duration of response will be estimated from time of documentation of response to time of progression and will be evaluated by computed tomography/magnetic resonance imaging scans of the organ(s) with the target lesion(s) based on RECIST criteria.
Measured: Up to 2 years after study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start17 Apr 2019
- Primary completion29 Jun 2022
- Study completion29 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Locally Advanced Unresectable Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Lexicon Pharmaceuticals
- Responsible party
- Principal investigator, Olumide Gbolahan, Emory University
- Investigators
- Gehan Botrus, MD, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03910387
- Sponsor's protocol ID
- IRB00105292
- Other IDs
- NCI-2018-01977, Winship4441-18
- Status last verified
- Nov 2025
- First submitted
- 9 Apr 2019
- Last updated
- 16 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Results of the trial and not individual patient data will be shared. The study protocol, consent, and investigator's brochure will be available. The statistical plan is incorporated into the protocol, along with inclusion and exclusion criteria.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Loss in Patients With Advanced Stage Pancreatic Cancer: Role of Serotonin and Effects of Telotristat Ethyl
- ClinicalTrials.gov ID
- NCT03910387
- Acronym / sponsor ID
- IRB00105292
- Conditions
- Locally Advanced Unresectable Pancreatic Adenocarcinoma, Metastatic Pancreatic Adenocarcinoma, Recurrent Pancreatic Adenocarcinoma, Stage III Pancreatic Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Lexicon Pharmaceuticals
- Study start
- 17 Apr 2019 (actual)
- Primary completion
- 29 Jun 2022 (actual)
- Study completion
- 29 Jun 2022 (actual)
- First posted
- 10 Apr 2019 (actual)
- Results
- Posted 16 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well telotristat ethyl works in promoting weight stability in patients with pancreatic adenocarcinoma that has come back and spread to other places in the body. Telotristat ethyl may decrease bowel movements which may make patients gain weight. Stabilizing weight may help patients tolerate chemotherapy better and improve longevity.
Detailed description
PRIMARY OBJECTIVES:
- Evaluate weight stability after 3 months of telotristat ethyl treatment in patients who have significant weight loss (documented to be more than or equal to 10%) prior to the start of treatment. (Group 1).
II. Evaluate the change in serum and 24-hours (hr) urine 5-hydroxyindoleacetic acid (5-HIAA) in patients with locally advanced unresectable, recurrent or metastatic pancreatic adenocarcinoma (PDAC) receiving chemotherapy. (Group 2).
SECONDARY OBJECTIVES:
- Evaluate the impact of weight stabilization/gain on patients in Group 1 on performance status, quality of life (QOL), mid arm circumference (MAC) and muscle mass on cross sectional imaging.
II. Evaluate correlations between changes in serotonin/ 5HIAA levels on radiologic response, weight stability, mid arm circumference (MAC), and muscle mass on cross sectional imaging.
III. Evaluate the relation of baseline serum and 24-hr urine 5-HIAA on weight loss in patients with advanced PDAC.
IV. Safety and tolerability of telotristat ethyl with gemcitabine/nab-paclitaxel combination chemotherapy.
- Evaluate response rate (RR) assessed per Response Evaluation Criteria in Solid Tumors (RECIST), progression free survival and overall survival in patients receiving telotristat ethyl (Group 1).
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP 1: Patients receive gemcitabine/nab-paclitaxel combination chemotherapy on days 1, 8 and 15, and telotristat ethyl orally (PO) once daily (QD), twice daily (BID), or thrice daily (TID) on days 1 and 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
GROUP 2: Patients receive 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.
After completion of study treatment, patients are followed up at 30 days, then every 8 weeks thereafter.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (gemcitabine/nab-paclitaxel and telotristat ethyl) | Experimental | Drug: Gemcitabine, Drug: Nab-paclitaxel, Drug: Telotristat EthylPatients 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 | Drug: Gemcitabine, Drug: Nab-paclitaxelPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- 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 separately.
- GROUP 1 (Telotristat ethyl treatment group): Weight loss of 10% or more.
- GROUP 1 (Telotristat ethyl treatment group): Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 within 14 days prior to registration.
- GROUP 1 (Telotristat ethyl treatment group): Histologic or cytological diagnosis of recurrent or metastatic pancreas adenocarcinoma (PDAC) who present for first line chemotherapy treatment for metastatic disease.
- GROUP 1 (Telotristat ethyl treatment group): Advanced stage pancreas cancer (recurrent/metastatic).
Key exclusion criteria (19 listed)
- GROUP 1 (Telotristat ethyl treatment group): Subjects with histology other than adenocarcinoma. Examples include: neuroendocrine tumors, acinar cell cancer, sarcoma or lymphoma of the pancreas.
- GROUP 1 (Telotristat ethyl treatment group): Ongoing or active infection.
- GROUP 1 (Telotristat ethyl treatment group): Symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia. Symptomatic heart failure (New York Heart Association [NYHA] Class II-IV).
- GROUP 1 (Telotristat ethyl treatment group): Acute or sub-acute intestinal obstruction.
- GROUP 1 (Telotristat ethyl treatment group): Ascites.
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 |
|---|---|---|
| GemcitabineAlso: Gemzar, dFdCyd, DifluorodeoxycytidineGiven gemcitabine/nab-paclitaxel combination therapy | Drug | Group 1 (gemcitabine/nab-paclitaxel and telotristat ethyl), Group 2 (gemcitabine/nab-paclitaxel) |
| Nab-paclitaxelAlso: ABI-007, Abraxane, Nanoparticle Albumin-bound PaclitaxelGiven gemcitabine/nab-paclitaxel combination therapy | Drug | Group 1 (gemcitabine/nab-paclitaxel and telotristat ethyl), Group 2 (gemcitabine/nab-paclitaxel) |
| Telotristat EthylAlso: XermeloGiven PO | Drug | Group 1 (gemcitabine/nab-paclitaxel and telotristat ethyl) |
Primary outcome
Weight Stability
Time frame: Baseline up to 3 months after study start
Weight stability will be documented as percent weight change at 3 months compared to baseline.
7 secondary outcomes
Change in 24-hr Urine 5-hydroxyindoleacetic Acid (5-HIAA) Levels
Time frame: Baseline up to 4 months after study start
Mid Arm Circumference (MAC) Measured in cm
Time frame: Up to 2 years after study start
Quality of Life (QOL)
Time frame: Up to 2 years after study start
Blood Serotonin Levels
Time frame: Up to 2 years after study start
Response Rate (RR)
Time frame: Up to 2 years after study start
Median Overall Survival (MOS)
Time frame: Up to 2 years after study start
Duration of Response
Time frame: Up to 2 years after study start
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Results of the trial and not individual patient data will be shared. The study protocol, consent, and investigator's brochure will be available. The statistical plan is incorporated into the protocol, along with inclusion and exclusion criteria.
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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.
Gehan Botrus, MD, PhD principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine, Nab-paclitaxel and Telotristat Ethyl in people with Locally Advanced Unresectable Pancreatic Adenocarcinoma and Metastatic Pancreatic Adenocarcinoma, run by Emory University at 3 sites in United States.
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 26 inclusion and 19 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: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Weight Stability (time frame: Baseline up to 3 months after study start). 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 16 Dec 2025.