A Phase II Study of Apatinib in STS Patients

February 22, 2017 updated by: Yang Yao, Shanghai Jiao Tong University Affiliated Sixth People's Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

53

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: apatinib group
apatinib 500mg po qd
Drug: apatinib
apatinib 500mg po. qd.
Other Names:
  • apatinib mesylate tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6 months PFS rate
Time Frame: From baseline to 6 months
Analyse PFS rate at 6 months
From baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2017

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

February 22, 2017

First Submitted That Met QC Criteria

February 22, 2017

First Posted (Actual)

February 27, 2017

Study Record Updates

Last Update Posted (Actual)

February 27, 2017

Last Update Submitted That Met QC Criteria

February 22, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ahead-S301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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