A Phase II Study of Apatinib in STS Patients

NCT ID: NCT03064243

Last Updated: 2017-02-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2018-09-01

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.

Conditions

Soft Tissue Sarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

apatinib group

apatinib 500mg po qd

Group Type: EXPERIMENTAL

apatinib

Intervention Type: DRUG

apatinib 500mg po. qd.

Interventions

apatinib

apatinib 500mg po. qd.

Intervention Type: DRUG

Other Intervention Names

apatinib mesylate tablets

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yang Yao

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Yu W, Zhang H, Chen J, Zhang X, Chen Y, Qu G, Huang G, Zhou Y, Ye T, Fan Z, Yao Y. Efficacy and safety of apatinib in patients with untreated or chemotherapy-refractory soft tissue sarcoma: a multicenter, phase 2 trial. Ann Transl Med. 2022 Sep;10(18):981. doi: 10.21037/atm-22-4229.

Reference Type: DERIVED

PMID: 36267741 (View on PubMed)

Other Identifiers

Ahead-S301

Identifier Type: -

Identifier Source: org_study_id