Surufatinib in Patients With Osteosarcoma and Soft Tissue Sarcoma

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

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

Study Overview

• Status: Recruiting
• Conditions: Sarcoma
• Intervention / Treatment: Drug: Surufatinib

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 47
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xing Zhang, professor; Phone Number: 020-87343383; Email: zhangxing@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Sun Yat-Sen Univerisity
      • Contact: Xing Zhang, PHD、MD; Phone Number: 86-020-87343192; Email: zhangxing@sysucc.org.cn
      • Principal Investigator: Xing Zhang, PHD、MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Surufatinib; Drug: Surufatinib Surufatinib will be given orally.	Drug: Surufatinib; Surufatinib 300 mg once a day (QD) will be orally administrated on a 21-day cycle.; Other Names: HMPL-012

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression-free rate at 12weeks	at 12weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Progression-free survival (PFS)	up to 12 months
Disease control rate (DCR)	up to 12 months
Overall survival (OS)	up to 24 months
Objective response rate (ORR)	up to 12 months

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2021
• Primary Completion (Anticipated): December 10, 2023
• Study Completion (Anticipated): December 10, 2023

Study Registration Dates

• First Submitted: October 25, 2021
• First Submitted That Met QC Criteria: October 25, 2021
• First Posted (Actual): November 4, 2021

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Sarcoma; Osteosarcoma
• Other Study ID Numbers: HMPL-012-SPRING-OS101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No