NCT03491371

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 9, 2018

Completed
Last Updated

April 10, 2018

Status Verified

April 1, 2018

Enrollment Period

1.6 years

First QC Date

March 31, 2018

Last Update Submit

April 6, 2018

Conditions

EfficacyToxicity

Keywords

apatinibtyrosine-kinase inhibitorsosteosarcomaEwing sarcomachondrosarcomasoft-tissue sarcoma

Outcome Measures

Primary Outcomes (1)

  • objective response rate

    CR+PR accroding to RECIST 1.1

    3 month

Secondary Outcomes (4)

  • progression-free survival, PFS

    4 months and 6 months

  • duration of response, DOR

    4 months

  • Overall Survival,OS

    12 months

  • toxicity

    12 months

Study Arms (4)

osteosarcoma

EXPERIMENTAL

all patients had been given apatinib alone

Drug: Methylsulfonic apatinib

Ewing sarcoma

EXPERIMENTAL

Some of patients had been given apatinib alone while some of them had been given apatinib+everolimus

Drug: Methylsulfonic apatinib

soft tissue sarcoma

EXPERIMENTAL

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

Chondrosarcoma

EXPERIMENTAL

Patients were given apatinib alone

Drug: Methylsulfonic apatinib

Interventions

Methylsulfonic apatinibDRUG

Anti-angiogenesis Tyrosine kinase inhibitor which specifically inhibits VEGFR-2.

ChondrosarcomaEwing sarcomaosteosarcomasoft tissue sarcoma

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Musculoskeletal Tumor Center of Peking University People's Hospital

Beijing, 100044, China

Location

Peking University Shougang Hospital

Beijing, 100144, China

Location

MeSH Terms

Conditions

OsteosarcomaSarcoma, EwingChondrosarcomaSarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Bone TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2018

First Posted

April 9, 2018

Study Start

June 1, 2015

Primary Completion

December 31, 2016

Study Completion

February 1, 2017

Last Updated

April 10, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)