Anlotinib Maintenance Treatment for Advanced Soft Tissue Sarcoma

NCT03890068 | Unknown Phase 2 DMC

• 1 other identifier: SunYat-senU-anlotinib
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (1)

• Progress free survival for anlotinib maintenance treatment

  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.

  until Progressive Disease(PD) or death (up to 24 months)

Secondary Outcomes (4)

• Overall Survival

  From randomization until death (up to 24 months)

• Objective Response Rate

  each 42 days up to intolerance the toxicity or PD (up to 24 months)

• Disease Control Rate

  each 42 days up to intolerance the toxicity or PD (up to 24 months)

• Safety profile

  each 42 days up to intolerance the toxicity or PD (up to 24 months)

Study Arms (1)

anlotinib

EXPERIMENTAL

anlotinib for maintenance treatment a dose of 12 mg once daily (day1-14 PO) in 21-day cycles

Drug: Anlotinib Hydrochloride

Interventions

Anlotinib Hydrochloride DRUG

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.

Also known as: Anlotinib

anlotinib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated informed consent form prior to patient entry;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (1)

• Xu B, Pan Q, Pan H, Li H, Li X, Chen J, Pang D, Zhang B, Weng D, Peng R, Fang M, Zhang X. Anlotinib as a maintenance treatment for advanced soft tissue sarcoma after first-line chemotherapy (ALTER-S006): a multicentre, open-label, single-arm, phase 2 trial. EClinicalMedicine. 2023 Sep 21;64:102240. doi: 10.1016/j.eclinm.2023.102240. eCollection 2023 Oct.

  PMID: 37767191 DERIVED

MeSH Terms

Conditions

Sarcoma

Interventions

anlotinib

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Xing Zhang, professor

CONTACT

020-87343383; zhangxing@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice director of department of medical sarcoma and melanoma,Principal Investigator,Clinical Professor

Study Record Dates

• First Submitted: March 24, 2019
• First Posted: March 26, 2019
• Study Start: April 11, 2019
• Primary Completion: December 30, 2023
• Study Completion: May 30, 2024
• Last Updated: August 1, 2023

Record last verified: 2023-07

Locations

CN (1)