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TELE-ABC

Study Name
TELE-ABC
ClinicalTrials.gov Identifier (if applicable)
NCT03790111
Clinical Trial Category (check all that apply)
  • First Line Therapy
  • Other Novel Therapies
Study Center
Institution Name
Lexicon Pharmaceuticals, Inc.
Institution Address
8800 Technology Forest Place
City
The Woodlands
State
Texas
Zip Code
77381
Country
United States
Phone
(281) 863-3000
Website
http://www.lexpharma.com
Study Contacts
Principal Investigator
N/A
P.I. Phone
(000) 000-0000
P.I. Email
NA@notapplicable.com
Study Coordinator
Karie Arnold
Study Coordinator Phone
(281) 863-3317
Study Coordinator Email
karnold@lexpharma.com
OVERVIEW – in layman’s terms (150 words max)
There is a Screening Period of up to 42 days. This is followed by a Treatment Period with multiple cycles. Each cycle of the Treatment Period is 21 days. This period lasts until disease progression, signs of toxicity, or until the patient decides to stop the treatment. Next, there is a Follow-up Period that could last as long as 24 months.
Enrollment
54
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 test whether Xermelo®, when given with chemotherapy (cisplatin/gemcitabine) that is used as a standard treatment, will have an effect on the growth of biliary tract cancer (BTC) tumors. Safety of using these drugs in combination will also be evaluated. Xermelo® is not currently approved for use in BTC.
Inclusion Criteria – Patients Must:
  • Must be at least 18 years old, have confirmation of unresectable, locally advanced, recurrent, or metastatic BTC, and have plans to initiate cis/gem chemotherapy treatment as standard of care
Exclusion Criteria – Patients Must NOT:
  • Must not have prior exposure to Xermelo® or have the primary tumor in the ampulla of Vater
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