Surufatinib in Patients With Osteosarcoma and Soft Tissue Sarcoma

NCT05106777 | Unknown Phase 2

• 1 other identifier: HMPL-012-SPRING-OS101
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sarcoma

Outcome Measures

Primary Outcomes (1)

• Progression-free rate at 12weeks

  at 12weeks

Secondary Outcomes (4)

• Progression-free survival (PFS)

  up to 12 months

• Objective response rate (ORR)

  up to 12 months

• Disease control rate (DCR)

  up to 12 months

• Overall survival (OS)

  up to 24 months

Study Arms (1)

Surufatinib

EXPERIMENTAL

Drug: Surufatinib Surufatinib will be given orally.

Drug: Surufatinib

Interventions

Surufatinib DRUG

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

Also known as: HMPL-012

Surufatinib

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Fully understand the study and voluntarily sign the informed consent form;
• Male or female, age14-70 years，the body surface area of patients under 18 years old is ≥1.5m2;
• Histologically or cytologically confirmed advanced osteosarcoma and soft tissue sarcoma (unresectable or metastatic)；
• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1 (amputation patients 0-2).
• Life expectancy \> 12 weeks.
• Have measurable disease based on RECIST 1.1.

You may not qualify if:

• Prior treatment with Surufatinib;
• 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.
• Symptoms that affect oral medication and can not be controlled through proper treatment. (such as inability to swallow, chronic diarrhoea and intestinal obstruction, etc.)
• With pleural effusion or ascites, cause respiratory syndrome. (\> CTC AE grade 2 dyspnea \[grade 2 dyspnea refers to shortness of breath during a small amount of activity; affecting instrumental activities of daily life\])
• had central nervous system metastasis;
• 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.)
• Accepted surgical treatment, incision biopsy or significant traumatic injury within 28 days before grouping.
• Participated in other anti-tumor clinical trials within 4 weeks.
• had other kinds of malignant tumors at the same time; had cardiac insufficiency or arrhythmia;
• were pregnant or breastfeeding.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-Sen Univerisity

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Sarcoma

Interventions

surufatinib

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Xing Zhang, professor

CONTACT

020-87343383; zhangxing@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 4, 2021
• Study Start: December 10, 2021
• Primary Completion: December 10, 2023
• Study Completion: December 10, 2023
• Last Updated: April 12, 2023

Record last verified: 2023-04

Locations

CN (1)