A Phase II Study of Apatinib in STS Patients

Phase 2

• Conditions: Soft Tissue Sarcoma
• Interventions: Drug: apatinib

• Registration Number: NCT03064243
• Lead Sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-02
• Study First Submitted: 2017-02-22
• Study First Submitted QC: 2017-02-22
• Last Update Submitted: 2017-02-22
• Study First Posted: 2017-02-27
• Last Update Posted: 2017-02-27
• Study Start: 2017-03-01
• Primary Completion: 2018-03-01
• Study Completion: 2018-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 53

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
apatinib group	apatinib	apatinib 500mg po qd

Primary Outcome Measures

Name	Time	Method
6 months PFS rate	From baseline to 6 months	Analyse PFS rate at 6 months