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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03790111
Recruitment Status : Recruiting
First Posted : December 31, 2018
Last Update Posted : September 14, 2020
Sponsor:
Information provided by (Responsible Party):
TerSera Therapeutics LLC

Tracking Information
First Submitted Date  ICMJE December 25, 2018
First Posted Date  ICMJE December 31, 2018
Last Update Posted Date September 14, 2020
Actual Study Start Date  ICMJE February 28, 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 27, 2018)
  • Progression-free survival (PFS) rate [ Time Frame: Month 6 ]
  • Incidence of treatment emergent adverse events [ Time Frame: Through study completion, approximately 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 27, 2018)
  • Overall survival (OS) [ Time Frame: Month 6 ]
  • Overall survival (OS) [ Time Frame: Month 12 ]
  • Progression-free survival (PFS) rate [ Time Frame: Month 12 ]
  • Disease control rate (DCR) [ Time Frame: Month 6 ]
  • Disease control rate (DCR) [ Time Frame: Month 12 ]
  • Disease control rate (DCR) [ Time Frame: Through study completion, approximately 2 years ]
  • Objective response rate (ORR) [ Time Frame: Month 6 ]
  • Objective response rate (ORR) [ Time Frame: Month 12 ]
  • Objective response rate (ORR) [ Time Frame: Through study completion, approximately 2 years ]
  • Change from Baseline in plasma 5-hydroxyindoleacetic acid (5-HIAA) [ Time Frame: Month 6 ]
  • Change from Baseline in plasma 5-hydroxyindoleacetic acid (5-HIAA) [ Time Frame: Month 12 ]
  • Change from Baseline in plasma 5-hydroxyindoleacetic acid (5-HIAA) [ Time Frame: Through study completion, approximately 2 years ]
  • Change from Baseline in carbohydrate antigen 19-9 (CA 19-9) [ Time Frame: Month 6 ]
  • Change from Baseline in carbohydrate antigen 19-9 (CA 19-9) [ Time Frame: Month 12 ]
  • Change from Baseline in carbohydrate antigen 19-9 (CA 19-9) [ Time Frame: Through study completion, approximately 2 years ]
  • Weight change from Baseline [ Time Frame: Month 6 ]
  • Weight change from Baseline [ Time Frame: Month 12 ]
  • Weight change from Baseline [ Time Frame: Through study completion, approximately 2 years ]
  • Change from Baseline in plasma albumin [ Time Frame: Month 6 ]
  • Change from Baseline in plasma albumin [ Time Frame: Month 12 ]
  • Change from Baseline in plasma albumin [ Time Frame: Through study completion, approximately 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety and Efficacy Study of XERMELO® + First-line Chemotherapy in Patients With Advanced Biliary Tract Cancer
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Biliary Tract Cancer
Intervention  ICMJE 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])
Study Arms  ICMJE Experimental: TE
Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study
Intervention: Drug: telotristat ethyl
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 20, 2019)
53
Original Estimated Enrollment  ICMJE
 (submitted: December 27, 2018)
54
Estimated Study Completion Date  ICMJE May 2023
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Janine North 888 - 600- 8116 jnorth@tersera.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03790111
Other Study ID Numbers  ICMJE LX1606.1-207-BTC
LX1606.207 ( Other Identifier: Lexicon )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party TerSera Therapeutics LLC
Study Sponsor  ICMJE TerSera Therapeutics LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Nancy Joseph-Ridge, MD TerSera Therapeutics
PRS Account TerSera Therapeutics LLC
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP