Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Biliary Tract Adenocarcinoma Drug: Fruquintinib Phase 2

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Exploratory Study to Evaluate Efficacy and Safety of Fruquintinib as Second-line Treatment for Patients With Advanced or Metastatic Biliary Tract Cancer
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04156958


Contacts
Layout table for location contacts
Contact: Qiu Li, M.D. +86-28-85422589 fbqiu9@163.com
Contact: Pengfei Zhang, M.D. +86-17828163584 fly_121988@126.com

Locations
Layout table for location information
China, Beijing
Chinese PLA General Hospital 5th Medical Center Not yet recruiting
Beijing, Beijing, China
Contact: Zhen Zeng, M.D.    +86-15010540233    zengzhen1970@sina.com   
Principal Investigator: Zhen Zeng, M.D.         
China, Hebei
Hebei Tumor Hospital Not yet recruiting
Shijiazhuang, Hebei, China
Contact: Yudong Wang, M.D.    +86-15931166600    wyd_999@126.com   
Principal Investigator: Yudong Wang, M.D.         
China, Heilongjiang
Harbin Medical University Cancer Hospital Not yet recruiting
Harbin, Heilongjiang, China
Contact: Haibo Lu, M.D.    +86-13613657491    13613657491@126.com   
Principal Investigator: Haibo Lu, M.D.         
China, Hunan
The Second Xiangya Hospital of Central South University Not yet recruiting
Changsha, Hunan, China
Contact: Yawen Gao, M.D.    +86-18673194699    2948390593@qq.com   
Principal Investigator: Yawen Gao, M.D.         
China, Jilin
Jilin Cancer Hospital Not yet recruiting
Chang chun, Jilin, China
Contact: Huizheng Bao, M.D.    +86-15543739999    1622930252@qq.com   
Principal Investigator: Huizheng Bao, M.D.         
China, Shanxi
Shanxi Provincial Cancer Hospital Not yet recruiting
Taiyuan, Shanxi, China
Contact: Lijiao Zhang, M.D.    +86-13934598881    597121763@qq.com   
Principal Investigator: Lijiao Zhang, M.D.         
China, Sichuan
West China Hospital, Sichuan University Not yet recruiting
Chengdu, Sichuan, China, 610041
Contact: Qiu Li, M.D.    +86-28-85422589    fbqiu9@163.com   
Principal Investigator: Qiu Li, M.D.         
Sponsors and Collaborators
Sichuan University
Investigators
Layout table for investigator information
Principal Investigator: Qiu Li, M.D. West China Hospital

Layout table for additonal information
Responsible Party: Zhen-Yu Ding, Professor, Sichuan University
ClinicalTrials.gov Identifier: NCT04156958     History of Changes
Other Study ID Numbers: IIT-2165
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhen-Yu Ding, Sichuan University:
biliary tract adenocarcinoma
fruquintinib
anti-angiogenesis
Additional relevant MeSH terms:
Layout table for MeSH terms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms