Study Name
TELE-ABC Identifier (if applicable)
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
The Woodlands
Zip Code
United States
(281) 863-3000
Study Contacts
Principal Investigator
P.I. Phone
(000) 000-0000
P.I. Email
Study Coordinator
Karie Arnold
Study Coordinator Phone
(281) 863-3317
Study Coordinator Email
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.
Study Start Date
Estimated Completion Date
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