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Anlotinib Maintenance Treatment for Advanced Soft Tissue Sarcoma

NCT03890068 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2023-08-01

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

    collaborator INDUSTRY

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-11
Primary Completion
2023-12-30
Completion
2024-05-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03890068 on ClinicalTrials.gov