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

Primary Purpose

Efficacy, Toxicity

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Methylsulfonic apatinib
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Efficacy focused on measuring apatinib, tyrosine-kinase inhibitors, osteosarcoma, Ewing sarcoma, chondrosarcoma, soft-tissue sarcoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Musculoskeletal Tumor Center of Peking University People's Hospital
  • Peking University Shougang Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

osteosarcoma

Ewing sarcoma

soft tissue sarcoma

Chondrosarcoma

Arm Description

all patients had been given apatinib alone

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

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.

Patients were given apatinib alone

Outcomes

Primary Outcome Measures

objective response rate
CR+PR accroding to RECIST 1.1

Secondary Outcome Measures

progression-free survival, PFS
PFS was defined as time from the start of using apatinib until disease progression or death, whichever occurred first.
duration of response, DOR
The time from appearance of response or stable disease to progression or death was thus considered the DOR
Overall Survival,OS
OS was defined as time from the start of using apatinib until death.
toxicity
accroding to the Common Terminology Criteria for Adverse Events 4.0

Full Information

First Posted
March 31, 2018
Last Updated
April 6, 2018
Sponsor
Peking University People's Hospital
Collaborators
Peking University Shougang Hospital, Peking University International Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03491371
Brief Title
Apatinib for Advanced Sarcoma: Results From Multiple Institutions' Off-label Use
Official Title
The Effectivity and Toxicity of Methylsulfonic Apatinib for Extensively Pre-treated Advanced Sarcoma: a Multicentric Retrospective Study in China
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2015 (Actual)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
February 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University People's Hospital
Collaborators
Peking University Shougang Hospital, Peking University International Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Efficacy, Toxicity
Keywords
apatinib, tyrosine-kinase inhibitors, osteosarcoma, Ewing sarcoma, chondrosarcoma, soft-tissue sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
osteosarcoma
Arm Type
Experimental
Arm Description
all patients had been given apatinib alone
Arm Title
Ewing sarcoma
Arm Type
Experimental
Arm Description
Some of patients had been given apatinib alone while some of them had been given apatinib+everolimus
Arm Title
soft tissue sarcoma
Arm Type
Experimental
Arm Description
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.
Arm Title
Chondrosarcoma
Arm Type
Experimental
Arm Description
Patients were given apatinib alone
Intervention Type
Drug
Intervention Name(s)
Methylsulfonic apatinib
Intervention Description
Anti-angiogenesis Tyrosine kinase inhibitor which specifically inhibits VEGFR-2.
Primary Outcome Measure Information:
Title
objective response rate
Description
CR+PR accroding to RECIST 1.1
Time Frame
3 month
Secondary Outcome Measure Information:
Title
progression-free survival, PFS
Description
PFS was defined as time from the start of using apatinib until disease progression or death, whichever occurred first.
Time Frame
4 months and 6 months
Title
duration of response, DOR
Description
The time from appearance of response or stable disease to progression or death was thus considered the DOR
Time Frame
4 months
Title
Overall Survival,OS
Description
OS was defined as time from the start of using apatinib until death.
Time Frame
12 months
Title
toxicity
Description
accroding to the Common Terminology Criteria for Adverse Events 4.0
Time Frame
12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Musculoskeletal Tumor Center of Peking University People's Hospital
City
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Peking University Shougang Hospital
City
Beijing
ZIP/Postal Code
100144
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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