A Phase II Study of Apatinib in STS Patients

NCT03064243 | Unknown Phase 2

• 1 other identifier: Ahead-S301
• Study Type: interventional
• Target: 53
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 6 months PFS rate

  Analyse PFS rate at 6 months

  From baseline to 6 months

Study Arms (1)

apatinib group

EXPERIMENTAL

apatinib 500mg po qd

Drug: apatinib

Interventions

apatinib DRUG

apatinib 500mg po. qd.

Also known as: apatinib mesylate tablets

apatinib group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University Affiliated Sixth People's Hospital: lead

Related Publications (1)

• 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.

  PMID: 36267741 DERIVED

MeSH Terms

Conditions

Sarcoma

Interventions

apatinib

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: February 27, 2017
• Study Start: March 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: September 1, 2018
• Last Updated: February 27, 2017

Record last verified: 2017-02