A Phase II Study of Apatinib in STS Patients

Soft Tissue Sarcoma Clinical Trial

Official title:

Effectiveness and Safety of Apatinib for the Patients With Advanced Soft Tissue Sarcoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03064243
• Other study ID #: Ahead-S301
• Status: Not yet recruiting
• Phase: Phase 2
• First received: February 22, 2017
• Last updated: February 22, 2017
• Start date: March 1, 2017
• Est. completion date: September 1, 2018

Study information

• Verified date: February 2017
• Source: Shanghai Jiao Tong University Affiliated Sixth People’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 53
• Est. completion date: September 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sarcoma
• Soft Tissue Sarcoma

Intervention

Drug:
• apatinib
apatinib 500mg po. qd.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University Affiliated Sixth People’s Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 months PFS rate	Analyse PFS rate at 6 months	From baseline to 6 months