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A Phase II Study of Apatinib in STS Patients

Primary Purpose

Soft Tissue Sarcoma

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
apatinib
Sponsored by
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Soft Tissue Sarcoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Signed informed consent.
  • Histologically proven advanced soft tissue sarcoma, At least one measurable lesion. Including: Synovial sarcoma, leiomyosarcoma, Alveolar soft part sarcoma, Undifferentiated pleomorphic sarcoma / malignant fibrous histiocytoma, Liposarcoma, Fibrosarcoma, Clear cell sarcoma, Epithelioid sarcoma, Angiosarcoma, Spindle cell sarcoma, rhabdomyosarcoma treated by chemotherapy, Ewing's sarcoma of soft tissue/Primitive neuroectodermal tumor. Excluding: Malignant peripheral nerve sheath tumor, chondrosarcoma, Dermatofibrosarcoma protuberans, Gastrointestinal stromal tumor, Inflammatory myofibroblastic sarcoma, Malignant mesothelioma.
  • Must have evidence of unresectable residual disease.
  • In the last 6 months, at least one chemotherapy regimen (including anthracyclines) was used in patients who failed or were unable to tolerate treatment.
  • ECOG ps≤2.
  • Life expectancy: more than 3 months.
  • Prior aptinib less than 2 weeks and at least 1 month since prior aptinib；at least 1 month since prior inhibitor of mTOR or EGFR pathway.
  • Not pregnant or nursing；Fertile patients must use effective contraception.

  • Hematopoietic

    • HB≥90g/L
    • Absolute neutrophil count ≥ 1,500/mm^3
    • Platelet count ≥ 80,000/mm^3

Exclusion Criteria:

  • Uncontrollable hypertension;
  • Has influence of oral drugs;
  • Patients with high risk of gastrointestinal blooding;
  • INR>1.5×ULN，APTT>1.5×ULN;
  • Allergic to any ingredient of this product;
  • Less than 1 month since last major surgery;
  • Brain metastases;
  • With the second cancer.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    apatinib group

    Arm Description

    apatinib 500mg po qd

    Outcomes

    Primary Outcome Measures

    6 months PFS rate
    Analyse PFS rate at 6 months

    Secondary Outcome Measures

    Full Information

    First Posted
    February 22, 2017
    Last Updated
    February 22, 2017
    Sponsor
    Shanghai Jiao Tong University Affiliated Sixth People's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03064243
    Brief Title
    A Phase II Study of Apatinib in STS Patients
    Official Title
    Effectiveness and Safety of Apatinib for the Patients With Advanced Soft Tissue Sarcoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 1, 2017 (Anticipated)
    Primary Completion Date
    March 1, 2018 (Anticipated)
    Study Completion Date
    September 1, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shanghai Jiao Tong University Affiliated Sixth People's Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Apatinib is a kind of innovative medicines approved by China Food and Drug Administration（CFDA）, which was researched by Jiangsu Hengrui Pharmaceutical Co., Ltd. Apatinib is a kinase inhibitor of receptor tyrosine with VEGFR2. The protocol is to explore Apatinib for the effectiveness of advanced soft tissue sarcoma and safety.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Soft Tissue Sarcoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    53 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    apatinib group
    Arm Type
    Experimental
    Arm Description
    apatinib 500mg po qd
    Intervention Type
    Drug
    Intervention Name(s)
    apatinib
    Other Intervention Name(s)
    apatinib mesylate tablets
    Intervention Description
    apatinib 500mg po. qd.
    Primary Outcome Measure Information:
    Title
    6 months PFS rate
    Description
    Analyse PFS rate at 6 months
    Time Frame
    From baseline to 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Signed informed consent. Histologically proven advanced soft tissue sarcoma, At least one measurable lesion. Including: Synovial sarcoma, leiomyosarcoma, Alveolar soft part sarcoma, Undifferentiated pleomorphic sarcoma / malignant fibrous histiocytoma, Liposarcoma, Fibrosarcoma, Clear cell sarcoma, Epithelioid sarcoma, Angiosarcoma, Spindle cell sarcoma, rhabdomyosarcoma treated by chemotherapy, Ewing's sarcoma of soft tissue/Primitive neuroectodermal tumor. Excluding: Malignant peripheral nerve sheath tumor, chondrosarcoma, Dermatofibrosarcoma protuberans, Gastrointestinal stromal tumor, Inflammatory myofibroblastic sarcoma, Malignant mesothelioma. Must have evidence of unresectable residual disease. In the last 6 months, at least one chemotherapy regimen (including anthracyclines) was used in patients who failed or were unable to tolerate treatment. ECOG ps≤2. Life expectancy: more than 3 months. Prior aptinib less than 2 weeks and at least 1 month since prior aptinib；at least 1 month since prior inhibitor of mTOR or EGFR pathway. Not pregnant or nursing；Fertile patients must use effective contraception. Hematopoietic HB≥90g/L Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 80,000/mm^3 Exclusion Criteria: Uncontrollable hypertension; Has influence of oral drugs; Patients with high risk of gastrointestinal blooding; INR>1.5×ULN，APTT>1.5×ULN; Allergic to any ingredient of this product; Less than 1 month since last major surgery; Brain metastases; With the second cancer.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    36267741
    Citation
    Yu W, Zhang H, Chen J, Zhang X, Chen Y, Qu G, Huang G, Zhou Y, Ye T, Fan Z, Yao Y. Efficacy and safety of apatinib in patients with untreated or chemotherapy-refractory soft tissue sarcoma: a multicenter, phase 2 trial. Ann Transl Med. 2022 Sep;10(18):981. doi: 10.21037/atm-22-4229.
    Results Reference
    derived

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    A Phase II Study of Apatinib in STS Patients

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