Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Apatinib for Advanced Sarcoma: Results From Multiple Institutions' Off-label Use

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03491371
Recruitment Status : Completed
First Posted : April 9, 2018
Last Update Posted : April 10, 2018
Sponsor:
Collaborators:
Peking University Shougang Hospital
Peking University International Hospital
Information provided by (Responsible Party):
Peking University People's Hospital

Brief Summary:
Anti-angiogenesis Tyrosine kinase inhibitors (TKIs) have been proved to show promising effects on prolonging progression-free survival (PFS) for advanced sarcoma after failure of standard multimodal Therapy. Methylsulfonic apatinib is one of those TKIs which specifically inhibits VEGFR-2. This study summarizes the experience of three Peking University affiliated hospitals in off-label use of apatinib in the treatment of extensively pre-treated sarcoma.

Condition or disease Intervention/treatment Phase
Efficacy Toxicity Drug: Methylsulfonic apatinib Not Applicable

Detailed Description:
The investigators retrospectively analysed files of patients with advanced sarcoma not amenable to curative treatment, who were receiving an apatinib-containing regimen between June 1, 2015 and December 1, 2016. Fifty-six patients were included: 22 osteosarcoma, 10 Ewing's sarcoma, 3 chondrosarcoma and 21 soft tissue sarcoma.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effectivity and Toxicity of Methylsulfonic Apatinib for Extensively Pre-treated Advanced Sarcoma: a Multicentric Retrospective Study in China
Actual Study Start Date : June 1, 2015
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : February 1, 2017


Arm Intervention/treatment
Experimental: osteosarcoma
all patients had been given apatinib alone
Drug: Methylsulfonic apatinib
Anti-angiogenesis Tyrosine kinase inhibitor which specifically inhibits VEGFR-2.

Experimental: Ewing sarcoma
Some of patients had been given apatinib alone while some of them had been given apatinib+everolimus
Drug: Methylsulfonic apatinib
Anti-angiogenesis Tyrosine kinase inhibitor which specifically inhibits VEGFR-2.

Experimental: soft tissue sarcoma
Some of the patients had been given apatinib alone while some of the patients had been given apatinib together with GT chemotherapy, which was gemcitabine 1000 mg/m2 d1,8 and docetaxel 75 mg/m2 d8 once every 21 day.
Drug: Methylsulfonic apatinib
Anti-angiogenesis Tyrosine kinase inhibitor which specifically inhibits VEGFR-2.

Experimental: Chondrosarcoma
Patients were given apatinib alone
Drug: Methylsulfonic apatinib
Anti-angiogenesis Tyrosine kinase inhibitor which specifically inhibits VEGFR-2.




Primary Outcome Measures :
  1. objective response rate [ Time Frame: 3 month ]
    CR+PR accroding to RECIST 1.1


Secondary Outcome Measures :
  1. progression-free survival, PFS [ Time Frame: 4 months and 6 months ]
    PFS was defined as time from the start of using apatinib until disease progression or death, whichever occurred first.

  2. duration of response, DOR [ Time Frame: 4 months ]
    The time from appearance of response or stable disease to progression or death was thus considered the DOR

  3. Overall Survival,OS [ Time Frame: 12 months ]
    OS was defined as time from the start of using apatinib until death.

  4. toxicity [ Time Frame: 12 months ]
    accroding to the Common Terminology Criteria for Adverse Events 4.0



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1) histologically confirmed high-grade sarcoma;
  • 2) initial treatment in the orthopedic oncology departments of the three affiliated hospitals of Peking University;
  • 3) tumors not amenable to curative treatment or inclusion in clinical trials;
  • 4) unresectable local advanced lesions or multiple metastatic lesions that could not be cured by local therapy;
  • 5) measurable lesions according to Response Evaluation Criteria for Solid Tumors (RECIST1.1) [8];
  • 6) Eastern Cooperative Oncology Group performance status 0 or 1 [9]; and 7) acceptable hematologic, hepatic, and renal function.

Exclusion Criteria:

  • had been previously exposed to other TKIs;
  • had central nervous system metastasis;
  • had other kinds of malignant tumors at the same time; had cardiac insufficiency or arrhythmia;
  • had uncontrolled complications such as diabetes mellitus, coagulation disorders, urine protein ≥ ++ and so on;
  • had pleural or peritoneal effusion that needs to be handled by surgical treatment;
  • combined with other infections or wounds
  • were pregnant or breastfeeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03491371


Locations
Layout table for location information
China
Musculoskeletal Tumor Center of Peking University People's Hospital
Beijing, China, 100044
Peking University Shougang Hospital
Beijing, China, 100144
Sponsors and Collaborators
Peking University People's Hospital
Peking University Shougang Hospital
Peking University International Hospital

Layout table for additonal information
Responsible Party: Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT03491371    
Other Study ID Numbers: PKUPH-sarcoma 01
First Posted: April 9, 2018    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peking University People's Hospital:
apatinib
tyrosine-kinase inhibitors
osteosarcoma
Ewing sarcoma
chondrosarcoma
soft-tissue sarcoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Apatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action