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Anlotinib Hydrochloride Combined With Liposomal Doxorubicin in the Treatment of Locally Advanced or Metastatic Soft Tissue Sarcoma (ALTER-S001)

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ClinicalTrials.gov Identifier: NCT03880695
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : March 21, 2019
Sponsor:
Collaborators:
Peking University Shougang Hospital
Beijing Cancer Hospital
Tianjin Medical University Cancer Institute and Hospital
First Hospital of Jilin University
Hunan Cancer Hospital
Ruijin Hospital
Liaoning Tumor Hospital & Institute
Information provided by (Responsible Party):
GUO WEI, Peking University People's Hospital

Tracking Information
First Submitted Date  ICMJE March 14, 2019
First Posted Date  ICMJE March 19, 2019
Last Update Posted Date March 21, 2019
Estimated Study Start Date  ICMJE March 2019
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2019)
Progress free survival (PFS) [ Time Frame: each 42 days to evaluate up to intolerance the toxicity or PD (in first 24 weeks), each 84 days to evaluate up to intolerance the toxicity or PD (up to 24 months) ]
Calculated from the date of treatment start until last follow-up or death, whichever comes first.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2019)
  • Overall Survival (OS) [ Time Frame: From randomization until death (up to 24 months) ]
    Calculated from the date of treatment start until last follow-up or death, whichever comes first.
  • Objective Response Rate (ORR) [ Time Frame: each 42 days to evaluate up to intolerance the toxicity or PD (in first 24 weeks), each 84 days to evaluate up to intolerance the toxicity or PD (up to 24 months) ]
    Overall objective response measured using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  • Disease Control Rate (DCR) [ Time Frame: each 42 days to evaluate up to intolerance the toxicity or PD (in first 24 weeks), each 84 days to evaluate up to intolerance the toxicity or PD (up to 24 months) ]
    Disease Control Rate measured using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  • Quality of Life (QoL) [ Time Frame: each 42 days to evaluate up to intolerance the toxicity or PD (in first 24 weeks), each 84 days to evaluate up to intolerance the toxicity or PD (up to 24 months) ]
    QoL is measured by the World Health Organization Quality of Life (WHOQOL-BREF)
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 Anlotinib Hydrochloride Combined With Liposomal Doxorubicin in the Treatment of Locally Advanced or Metastatic Soft Tissue Sarcoma
Official Title  ICMJE Anlotinib Hydrochloride Combined With Liposomal Doxorubicin in the Treatment of Locally Advanced or Metastatic Soft Tissue Sarcoma : a One-arm, Multi-center, Prospective Clinical Trial (ALTER-S001)
Brief Summary The investigators explored the activity of anlotinib combined with Liposomal Doxorubicin in patients with Locally Advanced or Metastatic Soft Tissue Sarcoma
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sarcoma
Intervention  ICMJE Drug: Anlotinib+ Liposomal Doxorubicin
Anlotinib : 12 mg, qd, po day 8-21 every 3 weeks Liposomal Doxorubicin: 50 mg/m2, day 1 every 3 weeks
Other Name: Anlotinib+ LPD
Study Arms  ICMJE Experimental: Anlotinib+ Liposomal Doxorubicin
Anlotinib Hydrochloride Combined With Liposomal Doxorubicin Liposomal Doxorubicin 50mg/m2 Day 1 every-3-weeks (Q3W) and Anlotinib 12mg QD po at Day 8-21 Q3W and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent. Dose reductions/modifications will be applied as indicated by toxicities and/or patient tolerance.
Intervention: Drug: Anlotinib+ Liposomal Doxorubicin
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 17, 2019)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Signed the informed consent form prior to patient entry;
  • ≥ 14 years of age , regardless of gender;ECOG :0-1;Expected Survival Time: Over 3 months;
  • Histologically confirmed diagnosis of un-resectable or recurrent metastatic soft tissue sarcoma, such as: leiomyosarcoma, synovial sarcoma, undifferentiated pleomorphic sarcoma, liposarcoma , angiosarcoma, alveolar soft tissue sarcoma, and other sarcomas. The following histologies are excluded: embryonic rhabdomyosarcoma, chondrosarcoma, osteosarcoma, gastrointestinal stromal tumor and Ewing sarcoma/primary neuroectodermal tumor.
  • Previously without anthracyclines or other anti-tumor drugs
  • 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.
  • Normal main organs function as defined below: Hemoglobin (Hb) ≥ 80g / L, Neutrophils (ANC) ≥ 1.5 × 10^9 / L, Platelet count (PLT) ≥ 80 × 10^9 / 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%)
  • Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device,contraceptive and condom) throughout treatment and for at least 6 months after study is stopped;the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment,and the patients required to be non-lactating;Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped.

Exclusion Criteria:

  • Prior treatment with anlotinib or any other VEGFR tyrosine kinase inhibitor (such as sunitinib, sorafenib, bevacizumab, imatinib, famitinib, apatinib, regorafenib and other drugs).
  • 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.
  • A history of other malignancy ≤ 3 years previous
  • Known central nervous system metastases.
  • Imaging (CT or MRI) shows tumor lesions from large vessels ≤ 5 mm, 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);
  • The investigator judged that the presence of distinct pulmonary cavitary or necrotic tumors;
  • Serosal effusion with clinical symptoms requiring surgical management (including hydrothorax and ascites pericardial effusion)
  • With uncontrollable hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, despite optimal drug treatment).
  • Arrhythmias with grade II and above myocardial ischemia or myocardial infarction, poor control (including corrected QT interval(QTc) men ≥ 450 ms, women ≥ 470 ms).
  • According to NYHA criteria, grade III to IV cardiac insufficiency, or cardiac color Doppler ultrasound examination showed left ventricular ejection fraction (LVEF) <50%, myocardial infarction occurred within 6 months before enrollment, ≥ 2 congestive heart failure (New York Heart Association ( NYHA) rating ), uncontrolled angina, clinical pericardial disease, or electrocardiogram suggesting acute ischemia or active conduction system abnormalities.
  • Uncontrolled comorbid diseases, including but not limited to: poorly controlled diabetes, persistent active infections, or mental illness or social condition that may affect a subject's adherence to the study.
  • 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)
  • Renal insufficiency: urine routine indicates urinary protein ≥ ++, or confirmed 24-hour urine protein ≥ 1.0 g;
  • Patients with seizures and need treatment
  • Abnormal coagulation (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or activated partial thromboplastin time(APTT) > 1.5 ULN), with bleeding tendency or undergoing thrombolytic or anticoagulant therapy.
  • Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin.
  • Significant coughing blood in the 2 months before enrollment, or daily hemoptysis of 2.5ml or more.
  • History of psychotropic substance abuse who are unable to quit or have a mental disorder.
  • Tendencies of hereditary or acquired hemorrhagic and thrombotic (such as hemophilia patients, coagulopathy, thrombocytopenia, hypersplenism, etc.)
  • Any major unhealed wound, ulcer, or fracture occurred in a patient who had undergone major surgery or trauma within 4 weeks prior to enrollment.
  • Active period digestive ulcers.
  • Cavity sinus or perforation occurred within 6 months.
  • Participated in other anti-tumor clinical trials within 4 weeks.
  • Received a potent CYP3A4 inhibitor (such as ketoconazole, itraconazole, erythromycin, and clarithromycin) within 7 days, or received a potent CYP3A4 inducer within 12 days prior to the study (eg. catarrh Treatment with imipramine, rifampicin and phenobarbital).
  • Allergic reactions, hypersensitivity reactions or intolerance to anlotinib hydrochloride or its excipients.
  • Pregnancy or lactation.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Wei Guo, MD +86-13701195504 bonetumor@163.com
Contact: Xin Sun +86-10-66583761
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03880695
Other Study ID Numbers  ICMJE 2018PHD008-01
Has Data Monitoring Committee Not Provided
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 GUO WEI, Peking University People's Hospital
Study Sponsor  ICMJE Peking University People's Hospital
Collaborators  ICMJE
  • Peking University Shougang Hospital
  • Beijing Cancer Hospital
  • Tianjin Medical University Cancer Institute and Hospital
  • First Hospital of Jilin University
  • Hunan Cancer Hospital
  • Ruijin Hospital
  • Liaoning Tumor Hospital & Institute
Investigators  ICMJE Not Provided
PRS Account Peking University People's Hospital
Verification Date March 2019

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