Telotristat Ethyl in Promoting Weight Stability in Patients with Recurrent Advanced Pancreatic Adenocarcinoma

Active:	No
Cancer Type:	Pancreatic Cancer Unknown Primary	NCT ID:	NCT03910387
Trial Phases:	Phase II	Protocol IDs:	Winship4441-18 (primary) NCI-2018-01977 IRB00105292
Eligibility:	18 Years and older, Male and Female	Study Type:	Supportive care
Study Sponsor:	Emory University Hospital/Winship Cancer Institute
NCI Full Details:	http://clinicaltrials.gov/show/NCT03910387

Summary

This phase II trial studies how well telotristat ethyl works in promoting weight stability in patients with pancreatic adenocarcinoma that has come back (recurrent) and spread to other places in the body (advanced). Telotristat ethyl may decrease bowel movements which may make patients gain weight. Stabilizing weight may help patients tolerate chemotherapy better and improve longevity.

Objectives

PRIMARY OBJECTIVES:
I. Weight stability after 3 and 6 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:
I. 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.
V. 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. Cycles 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. Cycles 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.

Treatment Sites in Georgia

Emory Saint Joseph's Hospital
5665 Peachtree Dunwoody Road NE
Atlanta, GA 30342
www.emoryhealthcare.org

Emory University Hospital - Midtown
550 Peachtree Street NE
Atlanta, GA 30308
404-686-4411
www.emoryhealthcare.org

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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