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

Efficacy Clinical Trial

Official title:

The Effectivity and Toxicity of Methylsulfonic Apatinib for Extensively Pre-treated Advanced Sarcoma: a Multicentric Retrospective Study in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03491371
• Other study ID #: PKUPH-sarcoma 01
• Status: Completed
• Phase: N/A
• First received: March 31, 2018
• Last updated: April 6, 2018
• Start date: June 1, 2015
• Est. completion date: February 1, 2017

Study information

• Verified date: April 2018
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: February 1, 2017
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Efficacy
• Sarcoma
• Toxicity

Intervention

Drug:
• Methylsulfonic apatinib
Anti-angiogenesis Tyrosine kinase inhibitor which specifically inhibits VEGFR-2.

Locations

Country	Name	City	State
China	Musculoskeletal Tumor Center of Peking University People's Hospital	Beijing
China	Peking University Shougang Hospital	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Peking University People's Hospital	Peking University International Hospital, Peking University Shougang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective response rate	CR+PR accroding to RECIST 1.1	3 month
Secondary	progression-free survival, PFS	PFS was defined as time from the start of using apatinib until disease progression or death, whichever occurred first.	4 months and 6 months
Secondary	duration of response, DOR	The time from appearance of response or stable disease to progression or death was thus considered the DOR	4 months
Secondary	Overall Survival,OS	OS was defined as time from the start of using apatinib until death.	12 months
Secondary	toxicity	accroding to the Common Terminology Criteria for Adverse Events 4.0	12 months