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Fruquintinib as Second-line Treatment for Advanced/Metastatic Biliary Tract Adenocarcinoma (FSTAMBTA)

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ClinicalTrials.gov Identifier: NCT04156958
Recruitment Status : Not yet recruiting
First Posted : November 8, 2019
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
Zhen-Yu Ding, Sichuan University

Tracking Information
First Submitted Date  ICMJE November 6, 2019
First Posted Date  ICMJE November 8, 2019
Last Update Posted Date November 8, 2019
Estimated Study Start Date  ICMJE December 2019
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2019)
Progression free survival (PFS) [ Time Frame: Up to 5 years ]
Defined as the time from the date of enrollment to the first date of documented objective progression disease or of death from any cause
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2019)
  • Objective response rate (ORR) [ Time Frame: Up to 5 years ]
    Defined as the percentage of patients who have a partial or complete response to therapy
  • Disease control rate (DCR) [ Time Frame: Up to 5 years ]
    Defined as the percentage of patients who have achieved complete response, partial response and stable disease
  • Overall survival (OS) [ Time Frame: Up to 5 years ]
    Defined as the time from the date of enrollment to the date of death from any cause
  • Safety and Tolerability [ Time Frame: 3 months after the last administration of fruquintinib ]
    Defined by treatment-related adverse events as assessed by CTCAE v4.0
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fruquintinib as Second-line Treatment for Advanced/Metastatic Biliary Tract Adenocarcinoma
Official Title  ICMJE An Exploratory Study to Evaluate Efficacy and Safety of Fruquintinib as Second-line Treatment for Patients With Advanced or Metastatic Biliary Tract Cancer
Brief Summary The prospective, multicenter, single-arm design study is to evaluate the efficacy and safety of fruquintinib for patients with advanced or metastatic biliary tract adenocarcinoma who failed first-line chemotherapy with gemcitabine, platinum/S-1, and albumin paclitaxel.
Detailed Description

Biliary tract cancer arises from the epithelial cells of the bile ducts. Until nowadays, no standard second-line treatment has been established following recurrence from the first-line treatment. Angiogenesis plays a key role in the carcinogenesis and development of biliary tract adenocarcinoma. Studies have shown that VEGF is expressed in more than 50% of biliary tract adenocarcinoma, and microvessel density is significantly associated with tumor progression, metastasis, and prognosis. Fruquintinib (trade name: Elunate) is a novel small molecule tyrosine kinase inhibitor. It is currently being evaluated in clinical trials for multiple cancers including lung cancer, gastric cancer and colorectal cancer and showed strong anti-tumor activity. The aim of the study is to evaluate the efficacy and safety of fruquintinib for patients with advanced or metastatic biliary tract adenocarcinoma who failed first-line chemotherapy.

The trial is a prospective, multicenter, single-arm design study. Eligible participants with advanced or metastatic biliary tract adenocarcinoma who have failed first-line chemotherapy with gemcitabine, platinum/S-1, and albumin paclitaxel. The study will explore the efficacy and safety of second-line treatment with fruquintinib, and quality of life during treatment. Tumor assessment was performed every 8 weeks as defined by RECIST 1.1. Blood samples will be collected at baseline (before treatment) and 2 weeks after treatment, and cfDNA will be collected for gene detection analysis to evaluate the correlation between different gene mutations and their changes and efficacy.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Biliary Tract Adenocarcinoma
Intervention  ICMJE Drug: Fruquintinib
Fruquintinib will be administered orally at a dose of 5 mg/d, 3 weeks on, 1 week off (4 weeks as a cycle) until progression, unacceptable toxicity, or withdrawal unless toxicity not relieved after dose adjustment.
Other Name: Elunate
Study Arms  ICMJE Fruquintinib Arm
Fruquintinib, 5 mg once daily for 21 days, followed by 7 days off (28 days/cycle) treatment until progression, unacceptable toxicity, or withdrawal unless toxicity not relieved after dose adjustment.
Intervention: Drug: Fruquintinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 6, 2019)
33
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • (1) Patients must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure.

    (2) Age ≥18 years. (3) Histologically or cytologically confirmed diagnosis of advanced or metastatic biliary tract adenocarcinoma (4) First-line chemotherapy failed (tumor progression or intolerable adverse events).

    (5) The expected survival is no less than 3 months. (6) ECOG PS≤1. (7) At least one measurable lesion according to RECIST 1.1 criteria. (8) Adequate organ function including the following:

    • Total bilirubin ≤3 times upper limit of normal (ULN),
    • Aspartate transaminase (AST) and alanine transaminase (ALT) ≤5×ULN,
    • Alkaline phosphatase≤2.5×ULN (If the tumor invaded the liver, ≤5×ULN),
    • Serum creatinine≤1.5×ULN,
    • Serum amylase and lipase≤1.5×ULN,
    • International standardized ratio (INR)/partial prothrombin time (PTT)≤1.5×ULN;
    • Platelet count ≥ 75,000 /mm3.
    • Hemoglobin (Hb) ≥ 9 g/dL.
    • Absolute neutrophil count (ANC) ≥ 1500/mm3. (9) Strict contraception.

Exclusion Criteria:

  • (1) Unable to comply with the research program or procedures. (2) Undergoing other drug clinical trials, or has participated in any drug clinical trials one month before enrollment.

    (3) Uncontrolled hypertension (systolic pressure ≥140 mm Hg or diastolic pressure ≥ 90 mm Hg on repeated measurement) despite optimal medical management.

    (4) Active or clinically significant cardiac disease:

    • Congestive heart failure > New York Heart Association (NYHA ) class 2;
    • Active coronary artery disease;
    • Arrhythmias requiring treatment other than β-blocker or digoxin;
    • Unstable angina (with angina symptoms at rest), new angina within 3 months before enrollment, or new myocardial infarction within 6 months before enrollment (5) Evidence or history of bleeding diathesis or coagulopathy. (6) Grade 3 bleeding events 4 weeks before enrollment. (7) Thromboembolism or arteriovenous events, such as cerebrovascular events (including transient ischemic attack), deep vein thrombosis or pulmonary embolism, occurred 6 months before enrollment.

      (8) Currently taking anticoagulants. (9) Other tumors that have not been treated or exist at the same time, except carcinoma in situ of the cervix, treated basal cell carcinoma or superficial bladder tumor. If the tumor has been cured and no evidence of disease has been found for more than 3 years, the patient can be enrolled. All other tumors must be treated at least 3 years before enrollment.

      (10) Patients with pheochromocytoma. (11) Patients with a history of HIV infection or active hepatitis B/C. (12) Ongoing > level 2 infection. (13) Symptomatic brain metastasis or meningioma. (14) Unhealed wounds, ulcers or fractures. (15) Renal failure patients requiring blood or peritoneal dialysis. (16) Dehydration≥ 1 grade (17) Epileptic that need medication (18) Proteinuria≥ 3 grade (Urinary protein > 3.5g / 24hour) (19) Active, symptomatic interstitial pneumonia, pleural or ascites that causes dyspnea (dyspnea ≥ 2 grade) (20) History of organ transplantation. (including corneal transplantation). (21) Allergic to research drugs or similar drugs, or suspected allergies. (22) Malabsorption patients. (23) Pregnant or lactating women. (24) Investigator believes that patients who are not suitable for the study. (25) Medical, psychological or social conditions can affect the recruitment of patients and evaluation for study results.

      (26) Other anti-tumor therapy (chemotherapy, radiotherapy, surgery, immunotherapy, biotherapy, chemoembolization) other than investigator drugs (fruquintinib). Palliative external irradiation for non-target lesions is allowed.

      (27) Previously used fruquintinib or other angiogenesis inhibitors. (28) Major surgery 4 weeks before recruitment, open biopsy or major trauma surgery. (excluding biliary stents, or percutaneous biliary drainage) (29) Treatment with anti-tumor Chinese herbal medicine. (30) History of allogeneic blood transfusion within 6 months.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Qiu Li, M.D. +86-28-85422589 fbqiu9@163.com
Contact: Pengfei Zhang, M.D. +86-17828163584 fly_121988@126.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04156958
Other Study ID Numbers  ICMJE IIT-2165
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Zhen-Yu Ding, Sichuan University
Study Sponsor  ICMJE Sichuan University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Qiu Li, M.D. West China Hospital
PRS Account Sichuan University
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP