NCT03790111终止2 期
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)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Number of Participants With Progression-free Survival (PFS) as Evaluated by Central Radiologist's Assessment
研究概览
简要总结
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])
详细描述
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 cis plus 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 plus gem) is planned.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Xermelo 250mg plus first line therapy for a week, then Xermelo 500mg
Experimental
Xermelo 250 milligram (mg) plus first line therapy for a week, then Xermelo 500mg plus first line therapy for the duration of the study
干预措施: telotristat ethyl (Drug)
结局指标
主要结局
Number of Participants With Progression-free Survival (PFS) as Evaluated by Central Radiologist's Assessment
时间窗: Month 6
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions", or similar definition as accurate and appropriate.
Project Overall Survival Rate at Month 6
时间窗: 6 Months
Overall Survival (OS) was defined as the time from the frist dose of study treatment until the date of death due to any cause. Duration of Overall Survival (OS) in days is defined as (Date of event/censoring- date of First dose +1). Use Kaplan Meier method to project survival rate at month 6.
次要结局
- Mean Change From Baseline in Plasma 5-hydroxyindoleacetic Acid (5-HIAA)(End of Study as defined up to 24 months)
- Overall Survival (OS)(First dose of study treatment until the date of death due to any cause, whichever came first, a median of approximately 17.67 months)
- Project Overall Survival Rate at Month 12(12 Months)
- Median Progression Free Survival(Month 12)
- Disease Control Rate (DCR), Central Radiologist's Assessment(End of Study up to 24 months)
- Overall (Objective) Response Rate (ORR), Central Radiologist's Assessment(Month 12)
- Overall (Objective) Response Rate, Central Radiologist's Assessment(End of Study as defined up to 24 months)
- Summary of Duration of Progression Free Survival, Local Radiologist's Assessment(up to 7 months)
- Progression Free Survival, Local Radiologist's Assessment(End of Study as defined up to 24 months)
- Overall (Objective) Response Rate, Local Read(6 Months)
- Overall (Objective) Response Rate, Local Reader's Assessment(12 Months)
- Overall (Objective) Response Rate (ORR), Local Reader's Assessment(End of Study as defined up to 24 months)
- Disease Control Rate (DCR), Local Reviewer(Month 6)
- Disease Control Rate End of Study, Local Reviewer(End of Study as defined up to 24 months)
- Change From Baseline in Carbohydrate Antigen 19-9 (CA 19-9)(Month 12)
- Change From Baseline in Plasma Carbohydrate Antigen 19-9 (CA 19-9)(End of Study as defined up to 24 months)
- Weight Change From Baseline(End of Study as defined up to 24 months)
- Change From Baseline in Serum Albumin(End of Study as defined up to 24 months)
研究者
研究点 (1)
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