Study of Anlotinib in Patients With Soft Tissue Sarcoma（STS）(ALTER0203)

CTTQ

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Soft Tissue Sarcoma

Treatments: Drug: Placebo; Drug: Anlotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02449343

ALTN-02-IIB

Details and patient eligibility

About

Compare the effects and safety of Anlotinib with placebo in patients with soft tissue sarcoma.

Enrollment: 233 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed and dated informed consent
• Histological documentation of Soft Tissue Sarcoma,including Synovial sarcoma、Leiomyosarcoma、Alveolar soft part sarcoma、Undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma、Adipocytic Tumors、Fibrosarcoma、Clear cell sarcoma、Epithelioid sarcoma，With measurable disease.
• Within the past 6 months, using at least one failure of chemotherapy regimens (including anthracycline-based) in treating patients(except alveolar soft part sarcoma)
• 18-70years,ECOG PS:0-1,Life expectancy of more than 3 months
• Main organs function is normal
• 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
• With pleural effusion or ascites, cause respiratory syndrome
• Accepted the vascular endothelial growth inhibitor class targeted drug treatment of patients
• Plan to take systemic anti-tumor therapy within 4 weeks before grouping or during the medicine-taking period of this research, including Cytotoxic Therapy, Signal Transduction Inhibitor, and Immunotherapy (or who use Mitomycin C within 6 weeks before taking the treatment with experimental drug); The patients who have already taken Extended Field Radiotherapy (EF-RT) within 4 weeks before grouping or Limited Field Radiotherapy with proposed assessment of nidus within 2 weeks before grouping
• Symptoms of brain metastases cannot be controlled and treated within less than 2 months
• With severe and failed to controlled diseases
• Occurred venous thromboembolic events within 6 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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233 participants in 2 patient groups, including a placebo group

Anlotinib

Experimental group

Description:

Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Treatment:

Drug: Anlotinib

Placebo

Placebo Comparator group

Description:

Placebo QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Treatment:

Drug: Placebo