Study Name
TELE_ABC Telotristat Ethyl for Advanced Biliary Tract Cancer. A phase 2, multicenter, open-label safety and efficacy study of Xermelo® plus first-line chemotherapy in patients with locally advanced, unresectable, recurrent or metastatic BTC
ClinicalTrials.gov Identifier (if applicable)
NCT03790111
Clinical Trial Category (check all that apply)
  • First Line Therapy
  • Chemotherapy
Study Center
Institution Name
TerSera Therapeutics
Institution Address
8800 Technology Forest Place
City
The Woodlands
State
Texas
Zip Code
77381-1160
Country
United States
Phone
(281) 863-3000
Website
http://tersera.com
List additional Institutions (include address, phone number, and website)
Institution City State Zip Code
Levine Cancer Center Charlotte NC 28402
Moffitt Cancer Center Tampa FL 33612
Northwell Health Lake Success NY 11042
University of Kansas Overland Park KS 66210
Univ Iowa Iowa City IA 52242
Houtson Methodist Houston TX 77030
Univ FL Gainesville FL 32610
St Joseph Fullerton CA 92835
Banner Gilbert AZ 85234
Univ Chicago Chicago IL 60637
UTSW San Antonio TX 78229
Univ OK Oklahoma City OK 73104
Univ KY Lexington KY 40508
Roswell Park Buffalo NY 14263
Cancer Hematology Centers of W MI
Grand Rapids MI 49503
Study Contacts
Principal Investigator
Dr Richard Kim (Moffitt Cancer Center) & Dr Renuka Iyer (Roswell Park Cancer Center)
P.I. Phone
(000) 000-0000
P.I. Email
Study Coordinator
Janine North
Study Coordinator Phone
888 – 600- 8116
Study Coordinator Email
jnorth@tersera.com
List additional Study Coordinators (include phone number and email)
Dr. Nancy Joseph-Ridge (888 – 600- 8116)
OVERVIEW – in layman’s terms (150 words max)
Eligible patients with signed informed consent receive Telotristat Ethyl 250 mg (1 tab) 3 times daily for the 1st 7 days and then 500 mg (2 tabs) 3 times a day thereafter. Patients will also receive chemotherapy (Gemcitabine & Cisplatin) intravenously on Day 1 and Day 8 of each 21-day cycle, until end of study, progression, or consent withdrawal
Enrollment
53
Study Start Date
03/13/2019
Estimated Completion Date
02/28/2023
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
  • The purpose of this study is to:
  • Assess whether Telotristat Ethyl when given with first-line chemotherapy (Gemcitabine & Cisplatin)) as standard of care, will have an effect on the growth of biliary tract cancer (BTC) tumors.
  • Assess the safety of these drugs in combination. Telotristat Ethyl (Xermelo®) is not currently approved for use in BTC
  • Additional secondary endpoints include
  • Assessment of weight change from start of therapy
  • Assessment in changes in serum albumin level from the start of treatment
  • Assessment of changes in cancer biomarkers and enzymes
  • Assessment of health-related quality of life during treatment
Inclusion Criteria – Patients Must:
  • Be at least 18 years of age
  • Agree to use contraception during study and for 30 days after the last treatment dose (patients of childbearing potential)
  • Have confirmed diagnosis of unresectable, locally advanced, recurrent, or metastatic BTC
  • Have disease measurable on radiology scan
  • Be naive to tumor-directed therapy in locally advanced, unresectable, or metastatic setting
  • Have plans to initiate first line chemotherapy treatment with gemcitabine & cisplatin
  • Be able to provide written informed consent prior to participation in any study-related procedure
  • Not be bedridden, and meet minimal physical performance criteria (ECOG score 0-1)
Exclusion Criteria – Patients Must NOT:
  • Have prior exposure to study drug (Telotristat Ethyl)
  • Have a primary tumor site in the ampulla of Vater
  • Have received treatment with photodynamic therapy for localized disease or to relieve biliary obstruction within the past 30 days
  • Have a positive pregnancy test result, be pregnant, or breast-feeding
  • Have experienced a myocardial infarction within the past 6 months
  • Have any clinically significant and/or uncontrolled cardiac-related abnormality
  • Have any other clinically significant laboratory abnormality, per study protocol
REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms
  • CT or MRI
  • Serum pregnancy test (for females of childbearing potential)
  • Urinalysis
  • Hematology and blood chemistry labs
  • ECG
  • Physical Examination
POTENTIAL SIDE-EFFECTS – in layman’s terms
  • Telotristat Ethyl has a favorable side effect profile and is currently FDA approved for use in treatment of Carcinoid Syndrome Diarrhea in patients whose carcinoid syndrome diarrhea is not adequately controlled with a somatostatin analog alone.
  • Potential Side effects associated with Telotristat Ethyl:
  • Very common (≥10% of participants): abdominal pain; nausea treatable by standard anti-nausea medication if needed; fatigue; increased gamma-glutamyl transferase (a liver enzyme)
  • Common (≥1% to <10% of participants): constipation; abdominal bloating; gas; swelling of the extremities; fever; increased liver enzymes (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase); decreased appetite; headache; depression (including depression, decreased interest, and depressed mood)
  • Please consult your Health Care Professional for a list of side effects associated with Gemcitabine & Cisplatin Standard of Care combination chemotherapy.