Unresectable Biliary Tract Cancer
Conditions
Interventions
investigational material(s)
Generic name etc : Lenvatinib
INN of investigational material : Lenvatinib
Therapeutic category code : 42- Antineoplastic agents
Dosage and Administration for Investigation
Sponsors
Eisai Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Pathologically or cytologically confirmed adenocarcinoma of biliary tract cancer (BTC; intrahepatic, extrahepatic cholangiocarcinoma, gall bladder cancer and ampulla of Vater cancer) 2.Unresectable (e.g. locally advanced or metastatic) BTC 3.One prior gemcitabine-based doublet chemotherapy (e.g. gemcitabine and cisplatin) to unresectable BTC and not treated by any other chemotherapy to BTC 4.ECOG Performance Status of 0-1. 5.Survival expectation of 3 months or longer after beginning of study treatment 6.Males or females age >=20 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.Subjects with adequate function of major organs and blood coagulation: 10.Subjects must voluntarily agree to provide written informed consent 11.Subjects must be willing and able to comply with all aspects of the protocol
Exclusion criteria
Exclusion criteria: 1.Any anti-cancer treatment (except BSC) within 21 days prior to the first dose of study drug 2.Major surgery (any surgical procedure that involves anesthesia or respiratory assistance) within 21 days prior to the first dose of study drug or scheduled surgery during the study (except for bile duct drainage) 3.Ascites of moderate, severe or requiring drainage 4.Proteinuria of >=2+ on dipstick testing (Grade 480 ms) 8.Known to be human immunodeficiency virus (HIV) positive 9.Active infection requiring systemic treatment 10.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.) 11.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 12.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 13.Diagnosed with meningeal carcinomatosis 14.Subjects with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 28 days prior to the first dose of study drug. Any signs (eg, radiologic) or symptoms of brain metastases must be stable for at least 28 days prior to the first dose of study drug. 15.Known intolerance to the study drug or any of the excipients 16.History of drug or alcohol dependency or abuse within the last 24 months prior to the first dose of study drug 17.Any medical or other condition that in the opinion of the investigator(s) would preclude the subject's participation in a clinical study 18.Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive human chorionic gonadotropin [hCG or beta-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. 19. 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 the use of condom, contraceptive sponge, contraceptive foam, contraceptive jelly, diaphragm, or intrauterine device, otherwise using oral contraceptive (percutaneous or transvaginal also allowed) for at least 28 days before the first dose of study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy safety Efficacy and Safety Tumor assessments will be performed using RECIST 1.1. | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics The pharmacokinetic Sparse pharmacokinetic (PK) samples will be collected at C1D1 (postdose), C1D8 (predose), C1D15 (pre/postdose) and C2D1 (predose) from all subjects and will be analyzed using the population approach. | — |
Countries
Japan
Outcome results
None listed