Telotristat Ethyl to Promote Weight Stability in Patients With Advanced Stage Pancreatic Cancer

NCT03910387 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: IRB00105292NCI-2018-01977Winship4441-18
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 3

Brief 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. Stabilizing weight may help patients tolerate chemotherapy better and improve longevity.

Conditions

Metastatic Pancreatic Adenocarcinoma; Recurrent Pancreatic Adenocarcinoma; Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Locally Advanced Unresectable Pancreatic Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Weight Stability

  Weight stability will be documented as percent weight change at 3 months compared to baseline.

  Baseline up to 3 months after study start

Secondary Outcomes (7)

• Change in 24-hr Urine 5-hydroxyindoleacetic Acid (5-HIAA) Levels

  Baseline up to 4 months after study start

• Mid Arm Circumference (MAC) Measured in cm

  Up to 2 years after study start

• Quality of Life (QOL)

  Up to 2 years after study start

• Blood Serotonin Levels

  Up to 2 years after study start

• Response Rate (RR)

  Up to 2 years after study start

Study Arms (2)

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.

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.

Drug: Gemcitabine; Drug: Nab-paclitaxel

Interventions

Nab-paclitaxel DRUG

Given gemcitabine/nab-paclitaxel combination therapy

Also known as: ABI-007, Abraxane, Nanoparticle Albumin-bound Paclitaxel

Group 1 (gemcitabine/nab-paclitaxel and telotristat ethyl); Group 2 (gemcitabine/nab-paclitaxel)

Telotristat Ethyl DRUG

Given PO

Also known as: Xermelo

Group 1 (gemcitabine/nab-paclitaxel and telotristat ethyl)

Gemcitabine DRUG

Given gemcitabine/nab-paclitaxel combination therapy

Also known as: Gemzar, dFdCyd, Difluorodeoxycytidine

Group 1 (gemcitabine/nab-paclitaxel and telotristat ethyl); Group 2 (gemcitabine/nab-paclitaxel)

Eligibility Criteria

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

You may qualify if:

• 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).
• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Emory University: lead
• National Cancer Institute (NCI): collaborator
• Lexicon Pharmaceuticals: collaborator

Study Sites (3)

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; Taxes; telotristat ethyl

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Economics; Health Care Economics and Organizations

Results Point of Contact

• Title: Dr. Olumide Gbolahan
• Organization: Emory University

ogbolah@emory.edu

404-778-1900

Study Officials

• Gehan Botrus, MD, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: April 10, 2019
• Study Start: April 17, 2019
• Primary Completion: June 29, 2022
• Study Completion: June 29, 2022
• Last Updated: December 16, 2025
• Results First Posted: December 16, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)