Phase 2 N=23 Randomized Supportive Care

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

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

Bottom Line

View on ClinicalTrials.gov: NCT03910387 ↗

Enrolled (actual)

Serious AEs

9.1%

Results posted

Dec 2025

Primary outcome: Primary: Weight Stability — -1.98; -5.58 Percent weight change

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Gemcitabine (Drug); Nab-paclitaxel (Drug); Telotristat Ethyl (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Emory University
Primary completion: Jun 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Weight Stability	-1.98; -5.58	—
SECONDARY Change in 24-hr Urine 5-hydroxyindoleacetic Acid (5-HIAA) Levels	3; 4; 8; 3; 8; 2	—
SECONDARY Mid Arm Circumference (MAC) Measured in cm	24.35; 34.88; 24.39; 35.88; 23.98; 35.5	—
SECONDARY Quality of Life (QOL)	—	—
SECONDARY Blood Serotonin Levels	170.92; 294.67; 152.75; 201.33; 96.09; 217	—
SECONDARY Response Rate (RR)	11; 6	—
SECONDARY Median Overall Survival (MOS)	10.7; 12.2	—
SECONDARY Duration of Response	94; 97	—

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.

Eligibility Criteria

Inclusion Criteria

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).
GROUP 1 (Telotristat ethyl treatment group): Aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN) or 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.

Exclusion Criteria

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-feed

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03910387). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.