Surufatinib in Patients With Osteosarcoma and Soft Tissue Sarcoma

Sarcoma Clinical Trial

Official title:

A Multi-center, Open Label Study of Surufatinib in Patients With Osteosarcoma and Soft Tissue Sarcoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05106777
• Other study ID #: HMPL-012-SPRING-OS101
• Status: Recruiting
• Phase: Phase 2
• Start date: December 10, 2021
• Est. completion date: December 10, 2023

Study information

• Verified date: April 2023
• Source: Sun Yat-sen University
• Contact: Xing Zhang, professor
• Phone: 020-87343383
• Email: zhangxing[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose is to evaluate the effectiveness and safety of Surufatinib in patients with osteosarcoma and soft tissue sarcoma after Standard chemotherapy therapy.

Description:

The study population is patients with advanced osteosarcoma and soft tissue sarcoma who have failed in standard chemotherapy treatment. Surufatinib 300 mg once a day (QD) will be orally administrated on a 21-day cycle. Investigators will evaluate the clinical tumor response to Surufatinib, and if investigators determine that the patient can benefit from the continuation of treatment, the patient will continue the Surufatinib treatment. The duration of study will be 2 years. At the time of study completion, if investigators believe patients can continue to benefit from the investigational product, patients may be provided with Surufatinib with the agreement of the sponsor.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 47
• Est. completion date: December 10, 2023
• Est. primary completion date: December 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Fully understand the study and voluntarily sign the informed consent form;

2. Male or female, age14-70 years,the body surface area of patients under 18 years old is =1.5m2;

3. Histologically or cytologically confirmed advanced osteosarcoma and soft tissue sarcoma (unresectable or metastatic);

4. The patient had previously failed standard chemotherapy,Prior adjuvant and neo-adjuvant therapy is permitted (chemotherapy, radiotherapy, investigational agents) if 6 months or more have passed since completion of therapy.

5. Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1 (amputation patients 0-2).

6. Life expectancy > 12 weeks.

7. Have measurable disease based on RECIST 1.1.

Exclusion Criteria:

1. Prior treatment with Surufatinib;

2. Systemic anti-tumor therapy, including cytotoxic therapy, signal transduction inhibitors, and immunotherapy, is planned for the first 4 weeks prior to enrollment or during the study. Radiation radiotherapy (EF-RT) was performed within 4 weeks prior to enrollment.

3. Symptoms that affect oral medication and can not be controlled through proper treatment. (such as inability to swallow, chronic diarrhoea and intestinal obstruction, etc.)

4. With pleural effusion or ascites, cause respiratory syndrome. (> CTC AE grade 2 dyspnea [grade 2 dyspnea refers to shortness of breath during a small amount of activity; affecting instrumental activities of daily life])

5. had central nervous system metastasis;

6. With severe and failed to controlled diseases. (including:1)Uncontrollable hypertension (systolic blood pressure =140 mmHg or diastolic blood pressure =90 mmHg, despite optimal drug treatment).2)Arrhythmias with grade II and above myocardial ischemia or myocardial infarction, poor control (including corrected QT interval(QTc) men = 450 ms, women = 470 ms) and = 2 congestive heart failure (New York Heart Association ( NYHA) rating).3)Poor control of diabetes (fasting blood glucose > 10mmol / L).4)Active or uncontrolled serious infection (= Common Terminology Criteria for Adverse Event(CTC AE) grade 2 infection);5)Patients with active hepatitis B or hepatitis C (hepatitis B: HBsAg-positive and hepatitis B virus(HBV) DNA = 500 IU/mL; hepatitis C: hepatitis C virus(HCV) RNA-positive and abnormal liver function), or active infection requiring antimicrobial treatment (eg Treated with antibacterial drugs, antiviral drugs, antifungal drugs);6)renal insufficiency: urine routine indicates urinary protein = ++, or confirmed 24-hour urine protein = 1.0 g;7)Patients with seizures and need treatment.)

7. Accepted surgical treatment, incision biopsy or significant traumatic injury within 28 days before grouping.

8. Participated in other anti-tumor clinical trials within 4 weeks.

9. had other kinds of malignant tumors at the same time; had cardiac insufficiency or arrhythmia;

10. were pregnant or breastfeeding.

Related Conditions & MeSH terms

• Osteosarcoma
• Sarcoma

Intervention

Drug:
• Surufatinib
Surufatinib 300 mg once a day (QD) will be orally administrated on a 21-day cycle.

Locations

Country	Name	City	State
China	Sun Yat-Sen Univerisity	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free rate at 12weeks		at 12weeks
Secondary	Progression-free survival (PFS)		up to 12 months
Secondary	Objective response rate (ORR)		up to 12 months
Secondary	Disease control rate (DCR)		up to 12 months
Secondary	Overall survival (OS)		up to 24 months