A Phase II Study of Apatinib in STS Patients

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 2

Conditions: Soft Tissue Sarcoma

Treatments: Drug: apatinib

Study type: Interventional

Funder types: Other

Identifiers

NCT03064243

Ahead-S301

Details and patient eligibility

About

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.

Enrollment: 53 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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53 participants in 1 patient group

apatinib group

Experimental group

Description:

apatinib 500mg po qd

Treatment:

Drug: apatinib