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Lexicon LX1606.207: A phase 2, multi-center, 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)

Description

A Phase 2, multi-center, open-label, two-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.

Status

Accepting new patients

Primary Study Objective(s)

The objectives of the study are to determine:

  • Progression-free survival (PFS) rate
  • Incidence of treatment emergent adverse events

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who:

  • Are male or females 18 years or older (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.)
  • Have histopathologically or cytologically-confirmed, unresectable, locally advanced, recurrent, or metastatic biliary tract cancer (BTC)
  • Are naïve to tumor-directed therapy in locally advanced, unresectable, or metastatic setting
  • Have measurable disease
  • Have Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Plan to initiate treatment with 1L therapy (cisplatin plus gemcitabine)
  • Are able to provide written informed consent prior to participation in any study-related procedure

    Excluding patients who:

    • Have had prior exposure to XERMELO, telotristat ethyl, telotristat etiprate, LX1032, or LX1606
    • Have a primary tumor site in the ampulla of Vater
    • Had treatment with photodynamic therapy for localized disease or to relieve biliary obstruction in the presence of metastatic disease within the past 30 days
    • Have 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
    • Have 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
    • Have plasma albumin <2.8 g/dL
    • Have total bilirubin >1.5 x ULN or >1.5 mg/dL
    • Have prothrombin time (PT) or international normalized ratio (INR) >1.5 x ULN
    • Have serum creatinine or serum urea >1.5 x ULN
    • Have estimated glomerular filtration rate (eGFR) <50 mL/min
    • Have had a positive pregnancy test, are pregnant, or are breastfeeding
    • Have any other clinically significant laboratory abnormality that would compromise patient safety or the outcome of the study
    • Have any clinically significant and/or uncontrolled cardiac-related abnormality that would compromise patient safety or the outcome of the study
    • Had myocardial infarction within the past six months
    • Have active bleeding diathesis
    • Have a life expectancy of three months or less 
    • Had current complaints of persistent constipation or a history of chronic constipation, bowel obstruction or fecaloma within the past 6 months
    • Are receiving chronic treatment with corticosteroids equal to or greater than 5 mg of prednisone per day (or equivalent) or other immunosuppressive agent(s)
    • Have a history and/or uncontrolled hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), or human immunodeficiency virus (HIV)-1 or HIV-2
    • Have a history of substance or alcohol abuse within the past two years
    • Have a history of galactose intolerance, deficiency of Lapp lactase, or glucose-galactose malabsorption
    • Have a history of malignancy or active treatment for malignancy within five years
    • Received a live, attenuated vaccine or have been in close contact with someone who has received a live, attenuated vaccine within the past month
    • Received 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
    • Received any protein or antibody-based therapeutic agents within the past three months
    • Had treatment with any tumor-directed therapy within the past six months with curative intent
    • Have a surgical or medical condition that, in the judgment of the Investigator, might compromise patient safety or the outcome of the study
    • Have 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
    • Have evidence of brain metastases
    • Are unable or unwilling to communicate or cooperate with the Investigator for any reason
    • Are an employee of sponsor or clinical site, or relative of any member of a clinical site's staff
    Learn more about gallbladder cancer and bile duct cancer