Brief Title
Study of Lenvatinib (E7080) in Unresectable Biliary Tract Cancer (BTC) Who Failed Gemcitabine-based Combination Chemotherapy
Official Title
An Open-Label, Multicenter Phase 2 Study of E7080/ LENVIMA (Lenvatinib Mesylate) in Subjects With Unresectable Biliary Tract Cancer Who Failed Gemcitabine-based Combination Chemotherapy
Brief Summary
This is a multicenter, single arm, open-label study in participants with unresectable BTC and
disease progression or failure following one prior gemcitabine-based doublet chemotherapy
regimen (combination of gemcitabine and cisplatin, or gemcitabine and other platinum
agent/fluoropyrimidine agent). This study contains 3 phases: a Pre-treatment phase that will
last within 21 days; a Treatment phase that will consist of study treatment cycles and tumor
assessment conducted every 6-8 weeks; and a Follow-up phase 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 End of Study.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Objective Response Rate (ORR)
Secondary Outcome
Progression-free Survival (PFS) Rate at 12 Weeks
Condition
Biliary Tract Cancer
Intervention
Lenvatinib
Study Arms / Comparison Groups
24 mg Lenvatinib
Description: Participants with unresectable BTC and disease progression or failure following one prior gemcitabine-based doublet chemotherapy regimen (combination of gemcitabine and cisplatin, or gemcitabine and other platinum agent/fluoropyrimidine agent).
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
29
Start Date
October 23, 2015
Completion Date
February 27, 2019
Primary Completion Date
November 22, 2016
Eligibility Criteria
Inclusion Criteria:
1. Pathologically or cytologically confirmed adenocarcinoma of biliary tract cancer
(intrahepatic, extrahepatic cholangiocarcinoma, gall bladder cancer, and ampulla of
Vater cancer)
2. Unresectable (eg, locally advanced or metastatic) BTC
3. One prior gemcitabine-based doublet chemotherapy (eg, gemcitabine and cisplatin) to
unresectable BTC and not treated by any other chemotherapy to BTC
- 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
4. 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
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
6. Survival expectation of 3 months or longer after beginning of study treatment
7. Males or females age ≥ 20 years at the time of informed consent
8. 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
9. 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)
10. Participants with adequate function of major organs and blood coagulation:
- 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. 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 ≤ 1 confirmed by quantitative
assessment is eligible)
5. Gastrointestinal malabsorption or any other condition that in the opinion of the
investigator might affect the absorption of study drug
6. 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
7. A prolonged QT/QTc interval (QTcF > 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. Participants 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 participant'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 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.
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
Gender
All
Ages
20 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, ,
Location Countries
Japan
Location Countries
Japan
Administrative Informations
NCT ID
NCT02579616
Organization ID
E7080-J081-215
Responsible Party
Sponsor
Study Sponsor
Eisai Co., Ltd.
Study Sponsor
, ,
Verification Date
October 2020