Lenvatinib in Patients With Previously Treated Advanced Biliary Tract Cancer

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Brief Title

Lenvatinib in Patients With Previously Treated Advanced Biliary Tract Cancer

Official Title

The Efficacy and Safety of Lenvatinib in Patients With Previously Treated Advanced Biliary Tract Cancer

Brief Summary

      This is a single center, nonrandom, open-label study aiming to evluate the efficacy and
      safety of lenvatinib for patients with pretreated advanced biliary tract cancer.
    

Detailed Description

      Lenvatinib targets VEGFR1, 2, and 3, PDGFRα, Fibroblast growth factor receptor (FGFR), and
      the KIT and RET tyrosine kinases and was initially developed for use in various tumor types.
      This is a single-center, non-random, open-label study in participants with unresectable BTC
      and disease progression or failure following at least one chemotherapy regimen. This study
      contains three procedures: a pre-treatment procedure that will last within 21 days; a
      treatment procedure that will consist of study treatment cycles and tumor assessment
      conducted every 6-8 weeks; and a follow-up procedure that will begin immediately after the
      off-treatment visit and will continue as long as the participant is alive, unless the
      participant withdraws consent, or until the terminal of the study.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Objective Response Rate (ORR)

Secondary Outcome

 Overall survival (OS)

Condition

Cholangiocarcinoma

Intervention

Lenvatinib

Study Arms / Comparison Groups

 Lenvatinib
Description:  Drug doses for BTC are identical, being orally administered at 8mg/d to patients weighing <60 kg and 12mg/d to those ≥60 kg.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

46

Start Date

January 1, 2018

Completion Date

May 1, 2021

Primary Completion Date

December 1, 2020

Eligibility Criteria

        Inclusion Criteria:

          -  Inclusion Criteria:

               1. Pathologically or cytologically confirmed adenocarcinoma of biliary tract cancer
                  (intrahepatic, extrahepatic cholangiocarcinoma, gall bladder cancer), at least
                  one prior chemotherapy.

               2. Participants who received adjuvant chemotherapy are eligible if this therapy was
                  completed and recurrent has not been shown for 6 months after the completion of
                  the therapy

               3. Measurable disease meeting the following criteria: At least 1 lesion of ≥ 1.0 cm
                  in the longest diameter for a non-lymph node or ≥ 1.5 cm in the short-axis
                  diameter for a lymph node that is serially measurable according to Response
                  Evaluation Criteria in Solid Tumors 1.1 (RECIST1.1) using computerized
                  tomography/magnetic resonance imaging (CT/MRI). Lesions that have had external
                  beam radiotherapy (EBRT) or locoregional therapies such as radiofrequency (RF)
                  ablation must show evidence of progressive disease based on RECIST 1.1 to be
                  deemed a target lesion.

               4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1

               5. Survival expectation of 3 months or longer after beginning of study treatment

               6. Males or females age ≥ 18 years at the time of informed consent

               7. All chemotherapy- or radiation-related toxicities must have resolved to Grade 0-1
                  per Common Terminology Criteria for Adverse Events (CTCAE v 4.03), except
                  alopecia, infertility, and the adverse events listed in inclusion criteria

               8. Adequately controlled blood pressure (BP) with or without antihypertensive
                  medications (defined as BP ≤ 150/90 mm Hg at Screening and no change in
                  antihypertensive medications within 1 week prior to the first dose of study drug)

               9. Participants with adequate function of major organs and blood coagulation:

              10. Absolute neutrophil count (ANC) ≥ 1500/mm^3 ( ≥ 1.5×103/μl); Platelets ≥
                  100,000/mm3 ( ≥ 100×10^9/L); Hemoglobin ≥ 9.0 g/dL; Bilirubin ≤ 2.0 mg/dL except
                  for unconjugated hyperbilirubinemia or Gilbert's syndrome; Alkaline phosphatase
                  (ALP), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) ≤ 3.0
                  × upper limit of normal (ULN) ( ≤ 5.0 × ULN for participants with the liver
                  metastasis); Creatinine clearance ≥ 40 mL/min per the Cockcroft and Gault
                  formula; Prothrombin time-International Normalized Ratio (PT-INR) ≤ 1.5;

              11. Participants must voluntarily agree to provide written informed consent;

              12. Participants must be willing and able to comply with all aspects of the protocol

        Exclusion Criteria:

          1. Ascites of moderate, severe, or requiring drainage

          2. Proteinuria of ≥ 2+ on dipstick testing (Grade ≤ 1 confirmed by quantitative
             assessment is eligible)

          3. Gastrointestinal malabsorption or any other condition that in the opinion of the
             investigator might affect the absorption of study drug

          4. New York Heart Association congestive heart failure of class II or above, unstable
             angina, myocardial infarction, or serious cardiac arrhythmia associated with
             significant cardiovascular impairment within the past 6 months from the first dose of
             study drug

          5. A prolonged QT/QTc interval (QTcF > 480 ms)

          6. Known to be human immunodeficiency virus (HIV) positive

          7. Active infection requiring systemic treatment

          8. Bleeding or thrombotic disorders or chronic systemic use of anticoagulants requiring
             therapeutic INR monitoring, eg, warfarin or similar agents (treatment with low
             molecular weight heparin is permitted)

          9. Gastrointestinal bleeding event or active hemoptysis (bright red blood of at least 0.5
             teaspoon) within 21 days prior to the first dose of study drug Active malignancy
             (except for BTC or definitively treated melanoma in-situ, basal or squamous cell
             carcinoma of the skin, carcinoma in-situ of the cervix, or early stage
             gastric/colorectal cancer) within the past 24 months prior to the first dose of study
             drug

         10. Known intolerance to the study drug or any of the excipients

         11. History of drug or alcohol dependency or abuse within the last 24 months prior to the
             first dose of study drug

         12. Any medical or other condition that in the opinion of the investigator(s) would
             preclude the participant's participation in a clinical study

         13. Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a
             positive human chorionic gonadotropin [hCG or B-hCG]). A separate baseline assessment
             is required if a negative screening pregnancy test was obtained more than 3 days
             before the first dose of study drug.

         14. For either males unless undergoing a successful vasectomy (confirmed azoospermia) or
             females of childbearing potential, the participant and his/her partner do not agree to
             use a medically appropriate method of contraception throughout the entire study period
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Hai-Tao Zhao, M.D., , 

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT04656249

Organization ID

PUMCH-JS-1391


Responsible Party

Sponsor

Study Sponsor

Peking Union Medical College Hospital


Study Sponsor

Hai-Tao Zhao, M.D., Principal Investigator, Peking Union Medical College Hospital


Verification Date

November 2020