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Anlotinib Hydrochloride for Soft Tissue Sarcoma Patients.

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. Identifier: NCT03890068
Recruitment Status : Recruiting
First Posted : March 26, 2019
Last Update Posted : March 17, 2020
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Information provided by (Responsible Party):
Xing Zhang, Sun Yat-sen University

Brief Summary:
Anlotinib is a multi-target receptor tyrosine kinase inhibitor. It can inhibit the angiogenesis related kinase, such as Vascular Endothelial Growth Factor Receptor (VEGFR), Fibroblast Growth Factor Receptor(FGFR), Platelet-Derived Growth Factor Receptor(PDGFR), and tumor cell proliferation related kinase c-Kit kinase. Anlotinib is an efficient second line therapeutic agent in treatment for metastatic soft tissue sarcoma which has been approved in clinical trials (ALTER-0203). Therefore, this study evaluates the safety and efficacy of anlotinib as maintenance treatment of disease control in advanced soft tissue sarcoma.

Condition or disease Intervention/treatment Phase
Soft Tissue Sarcoma Drug: Anlotinib Hydrochloride Phase 2

Detailed Description:

This regional multi-center study is planned to be carried out in Guangdong and Sichuan provinces. 48 cases are preliminarily expected to be included. The study will start in January 2019 and end in December 2019. It is expected that the trial will end in December 2020. This study evaluating the safety and efficacy of anlotinib as a maintenance treatment in advanced soft tissue sarcoma.

All those participants need to sign informed consent forms for data collection and be used for research purpose before inclusion. Participants remained PR/SD after ≥4 cycles of anthracyclines could be enrolled.

48 subjects with advanced soft tissue sarcoma will receive anlotinib at a dose of 12 mg once daily (day1-14 PO) in 21-day cycles until disease progression (defined by RECIST version 1.1) or unacceptable toxicity.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-arm, Multi-center Prospective Study of Anlotinib Hydrochloride for Locally Recurrent or Metastatic Soft Tissue Sarcoma Patients.(ALTER-S006)
Actual Study Start Date : April 11, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: anlotinib
anlotinib for maintenance treatment a dose of 12 mg once daily (day1-14 PO) in 21-day cycles
Drug: Anlotinib Hydrochloride
48 subjects with advanced soft tissue sarcoma will receive anlotinib at a dose of 12 mg once daily (day1-14 PO) in 21-day cycles until disease progression (defined by RECIST version 1.1) or unacceptable toxicity.
Other Name: Anlotinib

Primary Outcome Measures :
  1. Progress free survival [ Time Frame: until Progressive Disease(PD) or death(up to 24 months) ]
    Progress free survival defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause.

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: From randomization until death (up to 24 months) ]
    Overall survival is defined as the time until death due to any cause.

  2. Objective Response Rate [ Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months) ]
    Objective response rate is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.prior to progression or any further therapy.

  3. Disease Control Rate [ Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months) ]
    Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.

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.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Signed and dated informed consent form prior to patient entry;
  • 18-70 years , regardless of gender;ECOG :0-1;Expected Survival Time: Over 3 months;
  • Histologically confirmed diagnosis of advanced leiomyosarcoma, synovial sarcoma, liposarcoma or angiosarcoma.
  • Evaluable disease by imaging or physical exam or measurable disease defined as at least one lesion that can be accurately measured according to RECIST version 1.1.
  • PR/SD patients after ≥4 cycles anthracyclines treatment .
  • Main organs function is normal.(normal main organs function as defined below: Hemoglobin (Hb) ≥ 80g / L, Neutrophils (ANC) ≥ 1.5 × 109 / L, Platelet count (PLT) ≥ 80 × 109 / L, Serum creatinine (Cr) ≤ 1.5 × normal upper limit (ULN) or creatinine clearance (CCr) ≥ 60ml / min, Blood urea nitrogen (BUN) ≤ 2.5 × normal upper limit (ULN); Total bilirubin (TB) ≤ 1.5 × ULN; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; If accompanied by liver metastases, ALT and AST ≤ 5 × ULN Albumin (ALB) ≥ 25 g/L. Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ normal low limit (50%).)
  • The woman patients of childbearing age who must agree to take contraceptive methods (e.g. intrauterine device, contraceptive pill or condom) during the research and within another 6 months after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; The man patients who must agree to take contraceptive methods during the research and within another 6 months after it.

Exclusion Criteria:

  • Prior treatment with anlotinib.
  • A history of other malignancy ≤ 5 years previous.
  • Systemic anti-tumor therapy, including cytotoxic therapy, signal transduction inhibitors, and immunotherapy, is planned for the first 4 weeks prior to enrollment or during the study. Radiation radiotherapy (EF-RT) was performed within 4 weeks prior to enrollment.
  • Unmitigated toxic reactions above grade 1 of CTC AE due to any previous treatment, excluding alopecia.
  • Symptoms that affect oral medication and can not be controlled through proper treatment. (such as inability to swallow, chronic diarrhoea and intestinal obstruction, etc.)
  • With pleural effusion or ascites, cause respiratory syndrome. (> CTC AE grade 2 dyspnea [grade 2 dyspnea refers to shortness of breath during a small amount of activity; affecting instrumental activities of daily life])
  • Symptoms of brain metastases cannot be controlled and treated within less than 2 months.
  • Thyroid dysfunction after best support treatment.
  • With severe and failed to controlled diseases. (including:1)Uncontrollable hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, despite optimal drug treatment).2)Arrhythmias with grade II and above myocardial ischemia or myocardial infarction, poor control (including corrected QT interval(QTc) men ≥ 450 ms, women ≥ 470 ms) and ≥ 2 congestive heart failure (New York Heart Association ( NYHA) rating).3)Poor control of diabetes (fasting blood glucose > 10mmol / L).4)Active or uncontrolled serious infection (≥ Common Terminology Criteria for Adverse Event(CTC AE) grade 2 infection);5)Patients with active hepatitis B or hepatitis C (hepatitis B: HBsAg-positive and hepatitis B virus(HBV) DNA ≥ 500 IU/mL; hepatitis C: hepatitis C virus(HCV) RNA-positive and abnormal liver function), or active infection requiring antimicrobial treatment (eg Treated with antibacterial drugs, antiviral drugs, antifungal drugs);6)renal insufficiency: urine routine indicates urinary protein ≥ ++, or confirmed 24-hour urine protein ≥ 1.0 g;7)Patients with seizures and need treatment.)
  • Accepted surgical treatment, incision biopsy or significant traumatic injury within 28 days before grouping.
  • The investigator judged that during the follow-up study, the tumor is very likely to invade the important blood vessels and cause fatal hemorrhage, or the formation of tumor thrombosis with large veins (iliac vessels, inferior vena cava, pulmonary veins, superior vena cava)
  • Any major unhealed wound, ulcer, or fracture occurred in a patient who had undergone major surgery or trauma within 4 weeks and/or had any bleeding or bleeding episodes which the degree is bigger than CTCAE 3 grade within 4 weeks prior to enrollment.
  • Arteriovenous thrombosis events occurred within 6 months.
  • History of psychotropic substance abuse who are unable to quit or have a mental disorder.
  • Participated in other anti-tumor clinical trials within 4 weeks.
  • The investigator believes that there are any conditions that may damage the subject or result in the subject not being able to meet or perform the research request.

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 identifier (NCT number): NCT03890068

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Contact: Xing Zhang, professor 020-87343383

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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Xing Zhang, Professor    020-87343383   
Principal Investigator: Xing Zhang, professor         
Sponsors and Collaborators
Sun Yat-sen University
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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Responsible Party: Xing Zhang, Vice director of department of medical sarcoma and melanoma,Principal Investigator,Clinical Professor, Sun Yat-sen University Identifier: NCT03890068    
Other Study ID Numbers: SunYat-senU-anlotinib
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type