Lenvatinib in Patients With Previously Treated Advanced Biliary Tract Cancer

NCT04656249 | Completed Phase 2

• 1 other identifier: PUMCH-JS-1391
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholangiocarcinoma; Biliary Tract Cancer; Targeted Therapy

Keywords

Lenvatinib; Refractory biliary tract carcinoma; Efficacy; Biomarker

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate (ORR)

  Objective response rate

  Six months

• Progression free survival (PFS)

  Progression free survival

  Six months

Secondary Outcomes (3)

• Overall survival (OS)

  Two years

• Disease control rate (DCR)

  Six months

• The Rate of Treatment Related Adverse Events

  Three years

Other Outcomes (1)

• Clinical benefit rate (CBR)

  One years

Study Arms (1)

Lenvatinib

EXPERIMENTAL

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

Drug: Lenvatinib

Interventions

Lenvatinib DRUG

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

Also known as: E7080, Lenvima

Lenvatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically or cytologically confirmed adenocarcinoma of biliary tract cancer (intrahepatic, extrahepatic cholangiocarcinoma, gall bladder cancer), at least one prior chemotherapy.
• 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
• 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.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
• Survival expectation of 3 months or longer after beginning of study treatment
• Males or females age ≥ 18 years at the time of informed consent
• 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)
• 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;
• Participants must voluntarily agree to provide written informed consent;
• Participants must be willing and able to comply with all aspects of the protocol

You may not qualify if:

• Ascites of moderate, severe, or requiring drainage
• Proteinuria of ≥ 2+ on dipstick testing (Grade ≤ 1 confirmed by quantitative assessment is eligible)
• Gastrointestinal malabsorption or any other condition that in the opinion of the investigator might affect the absorption of study drug
• 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
• A prolonged QT/QTc interval (QTcF \> 480 ms)
• Known to be human immunodeficiency virus (HIV) positive
• Active infection requiring systemic treatment
• 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)
• 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
• Known intolerance to the study drug or any of the excipients
• History of drug or alcohol dependency or abuse within the last 24 months prior to the first dose of study drug
• Any medical or other condition that in the opinion of the investigator(s) would preclude the participant's participation in a clinical study
• 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.
• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Chinese Academy of Medical Sciences & Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

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MeSH Terms

Conditions

Cholangiocarcinoma; Biliary Tract Neoplasms

Interventions

lenvatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Hai-Tao Zhao, M.D.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients are confirmed with biliary tract cancers by imaging and histological examination and meet with the inclusive criteria, including intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, common bile duct cancer and gallbladder cancer.

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 7, 2020
• Study Start: January 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: May 1, 2021
• Last Updated: June 4, 2021

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)