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Tyrosine Kinase Inhibitor

surufatinib for Tumors

Phase 1 & 2
Waitlist Available
Research Sponsored by Hutchison Medipharma Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 18 years old
Fully understand the study and voluntarily sign the informed consent form
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of enrollment to progression or death up to 18 months
Awards & highlights

Study Summary

This trial is studying the side effects and best dose of surufatinib in treating patients with solid tumors that have spread to other parts of the body and cannot be removed by surgery. Surufatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of enrollment to progression or death up to 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of enrollment to progression or death up to 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of DLT
Progression Free Survival (PFS) rate
Secondary outcome measures
Objective response rate
maximum plasma concentration calculated with Blood samples
time to reach maximum concentration calculated with Blood samples

Trial Design

6Treatment groups
Experimental Treatment
Group I: ExpansionExperimental Treatment1 Intervention
Subjects will receive RP2D surufatinib daily treatment continuously with every 28-day treatment cycle. Four expansion cohorts will enroll BTC, pNET, EP-NET, and STS patients, respectively.
Group II: Escalation 50 mgExperimental Treatment1 Intervention
Escalation cohort at 50 mg/day
Group III: Escalation 400 mgExperimental Treatment1 Intervention
Escalation cohort at 400 mg/day
Group IV: Escalation 300 mgExperimental Treatment1 Intervention
Escalation cohort at 300 mg/day
Group V: Escalation 200 mgExperimental Treatment1 Intervention
Escalation cohort at 200 mg/day
Group VI: Escalation 100mgExperimental Treatment1 Intervention
Escalation cohort at 100 mg/day
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
surufatinib
2020
Completed Phase 2
~160

Find a Location

Who is running the clinical trial?

Hutchison Medipharma LimitedLead Sponsor
100 Previous Clinical Trials
13,391 Total Patients Enrolled
4 Trials studying Tumors
243 Patients Enrolled for Tumors
John Kauh, MDStudy ChairHutchmed
7 Previous Clinical Trials
322 Total Patients Enrolled
Vijay Jayaprakash, MDStudy DirectorHutchmed
4 Previous Clinical Trials
342 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~14 spots leftby Mar 2025