Apatinib for Advanced Osteosarcoma After Failure of Standard Multimodal Therapy

NCT02711007 | Completed Phase 2 DMC

• 1 other identifier: PKUPH-sarcoma
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

After standard multimodal therapy, the prognosis of relapsed and unresectable high-grade osteosarcoma is dismal and unchanged over the last decades.Thus, the investigators explored apatinib activity in patients with relapsed and unresectable osteosarcoma after the failure of first-line or second-line chemotherapy. Patients \>16 years, progressing after standard treatment, were eligible to receive 500 mg or 750 mg of apatinib once daily until progression or unacceptable toxicity. The primary end point was progression-free survival (PFS) at 4 months and objective response rate (ORR). Secondary objectives were PFS, overall survival (OS), clinical benefit rate (CBR), defined as no progression at 6 months and safety.

Conditions

Osteosarcoma; Metastasis

Keywords

osteosarcoma; metastasis; advanced; apatinib

Outcome Measures

Primary Outcomes (2)

• Progression-free survival, PFS

  calculated from the date of treatment start until the time of disease progression or death, whichever comes first.

  4 months

• Objective response rate, ORR

  CR+PR at 3 months

  3 months

Secondary Outcomes (3)

• Overall survival, OS

  12 months

• Clinical benefit rate, CBR

  6 months

• Duration of response, DOR

  6 months

Study Arms (1)

apatinib

EXPERIMENTAL

apatinib 750mg tablet or 500mg tablet by mouth, Qd half an hour after dinner

Drug: apatinib

Interventions

apatinib DRUG

Apatinib is a small-molecule VEGFR tyrosine kinase inhibitor, similar to vatalanib (PTK787), but with a binding affinity 10 times that of vatalanib or sorafenib.

apatinib

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• age \>16 years;
• diagnosis confirmed histologically and reviewed centrally;
• prior treatment (completed \>4 weeks before trial entry) consisted of standard high-grade osteosarcoma chemotherapy agents including doxorubicin, cisplatin, high- dose methotrexate, and ifosfamide; metastatic relapsed and unresectable progressive disease (PD);
• Eastern Cooperative Oncology Group performance status 0-1 with a life expectancy \>3 months;
• adequate renal, hepatic, and hemopoietic function;
• normal or controlled blood pressure;
• surgery and/or radiotherapy completion at least 1 month before enrollment.

You may not qualify if:

• no pulmonary artery or venous tumor embolus;
• previously exposed to other TKIs;
• central nervous system metastasis;
• have had other kinds of malignant tumors at the same time;
• cardiac insufficiency or arrhythmia;
• uncontrolled complications, such as diabetes mellitus and so on;
• coagulation disorders;
• urine protein≥ ++;
• pleural or peritoneal effusion that needs to be handled by surgical treatment;
• combined with other infections or wounds.

Sponsors & Collaborators

• GUO WEI: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Related Publications (27)

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MeSH Terms

Conditions

Osteosarcoma; Neoplasm Metastasis

Interventions

apatinib

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wei Guo, M.D. Ph.D.

  Chinese Medical Association--Sarcoma group

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: The Director of the Musculoskeletal Tumor Center of Peking University People's Hospital and the Principal Investigator of this study

Study Record Dates

• First Submitted: March 13, 2016
• First Posted: March 17, 2016
• Study Start: March 1, 2016
• Primary Completion: December 30, 2017
• Study Completion: January 8, 2018
• Last Updated: April 23, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)