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A Safety and Efficacy Study of XERMELO® + First-line Chemotherapy in Patients With Advanced Biliary Tract Cancer (TELE-ABC)

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ClinicalTrials.gov Identifier: NCT03790111
Recruitment Status : Not yet recruiting
First Posted : December 31, 2018
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
Lexicon Pharmaceuticals

Brief Summary:
A Phase 2, multicenter, open-label, 2-stage study to assess the safety, tolerability, and efficacy of XERMELO in combination with first-line (1L) therapy (cisplatin [cis] plus gemcitabine [gem]) in patients with unresectable, locally advanced, recurrent or metastatic biliary tract cancer (intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer), who are naïve to tumor-directed therapy in the locally advanced or metastatic setting, and for which treatment with 1L therapy (defined as a combination of cis/gem) is planned.

Condition or disease Intervention/treatment Phase
Biliary Tract Cancer Drug: telotristat ethyl Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Open-label, Safety and Efficacy Study of XERMELO® (Telotristat Ethyl) Plus First-line Chemotherapy in Patients With Locally Advanced, Unresectable, Recurrent or Metastatic Biliary Tract Cancer (BTC)
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TE
Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study
Drug: telotristat ethyl
XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study
Other Name: telotristat ethyl + (cisplatin [cis] plus gemcitabine [gem])




Primary Outcome Measures :
  1. Progression-free survival (PFS) rate [ Time Frame: Month 6 ]
  2. Incidence of treatment emergent adverse events [ Time Frame: Through study completion, approximately 2 years ]

Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: Month 6 ]
  2. Overall survival (OS) [ Time Frame: Month 12 ]
  3. Progression-free survival (PFS) rate [ Time Frame: Month 12 ]
  4. Disease control rate (DCR) [ Time Frame: Month 6 ]
  5. Disease control rate (DCR) [ Time Frame: Month 12 ]
  6. Disease control rate (DCR) [ Time Frame: Through study completion, approximately 2 years ]
  7. Objective response rate (ORR) [ Time Frame: Month 6 ]
  8. Objective response rate (ORR) [ Time Frame: Month 12 ]
  9. Objective response rate (ORR) [ Time Frame: Through study completion, approximately 2 years ]
  10. Change from Baseline in plasma 5-hydroxyindoleacetic acid (5-HIAA) [ Time Frame: Month 6 ]
  11. Change from Baseline in plasma 5-hydroxyindoleacetic acid (5-HIAA) [ Time Frame: Month 12 ]
  12. Change from Baseline in plasma 5-hydroxyindoleacetic acid (5-HIAA) [ Time Frame: Through study completion, approximately 2 years ]
  13. Change from Baseline in carbohydrate antigen 19-9 (CA 19-9) [ Time Frame: Month 6 ]
  14. Change from Baseline in carbohydrate antigen 19-9 (CA 19-9) [ Time Frame: Month 12 ]
  15. Change from Baseline in carbohydrate antigen 19-9 (CA 19-9) [ Time Frame: Through study completion, approximately 2 years ]
  16. Weight change from Baseline [ Time Frame: Month 6 ]
  17. Weight change from Baseline [ Time Frame: Month 12 ]
  18. Weight change from Baseline [ Time Frame: Through study completion, approximately 2 years ]
  19. Change from Baseline in plasma albumin [ Time Frame: Month 6 ]
  20. Change from Baseline in plasma albumin [ Time Frame: Month 12 ]
  21. Change from Baseline in plasma albumin [ Time Frame: Through study completion, approximately 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female adults, ≥18 years of age. Patients of childbearing potential must agree to use an adequate method of contraception during the study and for 30 days after the last dose of XERMELO
  • Histopathologically or cytologically-confirmed, unresectable, locally advanced, recurrent, or metastatic biliary tract cancer (BTC)
  • Naïve to tumor-directed therapy in locally advanced, unresectable, or metastatic setting
  • Measurable disease
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Plans to initiate treatment with 1L therapy (cisplatin plus gemcitabine)
  • Ability to provide written informed consent prior to participation in any study-related procedure

Exclusion Criteria:

  • Prior exposure to XERMELO, telotristat ethyl, telotristat etiprate, LX1032, or LX1606
  • Primary tumor site in the ampulla of Vater
  • Treatment with photodynamic therapy for localized disease or to relieve biliary obstruction in the presence of metastatic disease within the past 30 days
  • Hematology laboratory values of: a. Absolute neutrophil count (ANC) ≤1,500 cells/mm^3; or b. Platelets ≤100,000 cells/mm^3; or c. Hemoglobin (Hgb) ≤9 g/dL; or d. White blood count (WBC) ≤3,000 cells/mm^3
  • Hepatic laboratory values of aspartate aminotransferase (AST) or alanine aminotransferase (ALT): a. >5 x upper limit of normal (ULN) if patient has documented history of hepatic metastases; or b. >2.5 x ULN if no liver metastases are present
  • Serum albumin <2.8 g/dL
  • Total bilirubin >1.5 x ULN or >1.5 mg/dL
  • Prothrombin time (PT) or international normalized ratio (INR) >1.5 x ULN
  • Serum creatinine or serum urea >1.5 x ULN
  • Estimated glomerular filtration rate (eGFR) <50 mL/min
  • Positive pregnancy test, pregnant, or breastfeeding
  • Any other clinically significant laboratory abnormality that would compromise patient safety or the outcome of the study
  • Any clinically significant and/or uncontrolled cardiac-related abnormality that would compromise patient safety or the outcome of the study
  • Myocardial infarction within the past 6 months
  • Active bleeding diathesis
  • Life expectancy ≤3 months
  • Current complaints of persistent constipation or history of chronic constipation, bowel obstruction or fecaloma within the past 6 months
  • Receiving chronic treatment with corticosteroids ≥5 mg of prednisone per day (or equivalent) or other immunosuppressive agent(s)
  • History and/or uncontrolled hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), or human immunodeficiency virus (HIV)-1 or HIV-2
  • History of substance or alcohol abuse within the past 2 years
  • History of galactose intolerance, deficiency of Lapp lactase, or glucose-galactose malabsorption
  • History of malignancy or active treatment for malignancy within 5 years
  • Receipt of live, attenuated vaccine or close contact with someone who has received a live, attenuated vaccine within the past 1 month
  • Receipt of any investigational agent or study treatment (ie, any treatment or therapy not approved by the FDA for the treatment of BTC) within the past 30 days
  • Receipt of any protein or antibody-based therapeutic agents within the past 3 months
  • Treatment with any tumor-directed therapy within the past 6 months with curative intent
  • Existence of any surgical or medical condition that, in the judgment of the Investigator, might compromise patient safety or the outcome of the study
  • Presence of any clinically significant findings (relative to the patient population) during review of medical history or upon physical exam that, in the Investigator's or Medical Monitor's opinion, would compromise patient safety or the outcome of the study
  • Evidence of brain metastases
  • Unable or unwilling to communicate or cooperate with the Investigator for any reason
  • Employee of Sponsor or clinical site, or relative of any member of a clinical site's staff
  • Unable to read or understand English.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03790111


Contacts
Contact: Karie Arnold (281) 863-3317 karnold@lexpharma.com

Locations
United States, Florida
Lexicon Investigational Site Not yet recruiting
Tampa, Florida, United States, 33612
United States, New York
Lexicon Investigational Site Not yet recruiting
Buffalo, New York, United States, 14263
Sponsors and Collaborators
Lexicon Pharmaceuticals
Investigators
Study Director: Raul Perez-Olle, MD, PhD Lexicon Pharmaceuticals, Inc.

Responsible Party: Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03790111     History of Changes
Other Study ID Numbers: LX1606.1-207-BTC
LX1606.207 ( Other Identifier: Lexicon )
First Posted: December 31, 2018    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Diseases
Digestive System Diseases