- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03890068
Anlotinib Maintenance Treatment for Advanced Soft Tissue Sarcoma
A Single-arm, Multicentre, Phase II Clinical Trial of Anlotinib Maintenance Treatment After First-line Anthracycline-based Chemotherapy in Advanced Soft Tissue Sarcoma (ALTER-S006)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
48 cases are preliminarily expected to be included. This study evaluating the safety and efficacy of anlotinib as a maintenance treatment after first-line anthracycline-based chemotherapy 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.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Xing Zhang, professor
- Phone Number: 020-87343383
- Email: zhangxing@sysucc.org.cn
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510060
- Recruiting
- Sun Yat-sen University Cancer Center
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Contact:
- Xing Zhang, professor
- Phone Number: 020-87343383
- Email: zhangxing@sysucc.org.cn
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Principal Investigator:
- Xing Zhang, professor
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Signed and dated informed consent form prior to patient entry;
- 18-70 years , regardless of gender;ECOG :0-2;Expected Survival Time: Over 3 months;
- Subjects with pathologically confirmed advanced synovial sarcoma, leiomyosarcoma, liposarcoma, angiosarcoma, etc. (except malignant peripheral nerve sheath tumor, undifferentiated sarcoma, rhabdomyosarcoma, chondrosarcoma, osteosarcoma, dermato- fibrosarcoma protuberans, gastrointestinal stromal tumor, ewing's sarcoma/primitive neuroectodermal tumor, inflammatory myofibroblastic tumor, and malignant mesothelioma);
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: anlotinib
anlotinib for maintenance treatment a dose of 12 mg once daily (day1-14 PO) in 21-day cycles
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progress free survival for anlotinib maintenance treatment
Time Frame: until Progressive Disease(PD) or death (up to 24 months)
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Progress free survival defined as the time from first dose of anlotinib treatment until the first date of either objective disease progression or death due to any cause.
If the subject did not experience disease progression or death, PFS is defined as the period from the treatment start to the date of the last confirmed progression-free.
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until Progressive Disease(PD) or death (up to 24 months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease Control Rate
Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
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Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.
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each 42 days up to intolerance the toxicity or PD (up to 24 months)
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Objective Response Rate
Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
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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.
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each 42 days up to intolerance the toxicity or PD (up to 24 months)
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Overall Survival
Time Frame: From randomization until death (up to 24 months)
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Overall survival is defined as the time until death due to any cause.
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From randomization until death (up to 24 months)
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Safety profile
Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
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Adverse events were recorded throughout the treatment period and 21 days after the last dose and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
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each 42 days up to intolerance the toxicity or PD (up to 24 months)
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SunYat-senU-anlotinib
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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