← Back to Search

Tyrosine Kinase Inhibitor

Surufatinib for Neuroendocrine Cancer

Q: Where are the clinical trial sites for this research?

<p>The trial is based out of University of <a href="https://www.withpower.com/clinical-trials/alabama">Alabama</a>, Birmingham (UAB) in Birmingham, Alabama with other locations including University of <a href="https://www.withpower.com/clinical-trials/california">California</a> Irvine Medical Center UCIMC - H.H. Chao Comprehensive Digestive Disease Center CDDC in Orange, California and Stony Brook <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Center in Stony Brook, <a href="https://www.withpower.com/clinical-trials/new-york">New york</a> as well as 5 others.</p>

Phase 2

Waitlist Available

Research Sponsored by Hutchmed

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has histologically or cytologically documented, locally advanced, or metastatic NET and has progressed on at least 1 prior line of therapy, but no more than 3 therapies

Is ≥18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

Study Summary

This trial will test a new drug, surufatinib, on patients with low- to intermediate-grade neuroendocrine tumors.

Who is the study for?

This trial is for adults with low to intermediate grade, well-differentiated neuroendocrine tumors (NETs) who have seen their tumor grow within the last year. Participants must have tried at least one but no more than three treatments before and be in good physical condition. They should not have uncontrolled high blood pressure, recent serious blood clots or strokes, major surgery or radiation therapy shortly before starting the study, severe side effects from past cancer treatment that haven't improved enough (except hair loss and certain nerve damage), significant bleeding events recently, serious heart issues, ongoing infections needing IV drugs, previous VEGF/VEGFR-targeted therapy use, risk of heavy bleeding due to tumor location near big vessels, active gastrointestinal problems within six months prior to first dose of study drug or untreated brain metastases/spinal cord compression.Check my eligibility

What is being tested?

The trial is testing Surufatinib on its own in patients with specific types of NETs. It's a Phase 2 study which means they're looking at how effective this drug is and gathering more information about its safety. The trial doesn't compare it against another drug; instead everyone gets Surufatinib.See study design

What are the potential side effects?

Surufatinib can cause high blood pressure that might need medication adjustments. There's also a risk of developing blood clots or having stroke-like symptoms if you've had them recently. Other possible side effects include fatigue and digestive issues like diarrhea.

Eligibility Criteria

Inclusion Criteria

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

Select...

My advanced NET has worsened after 1-3 treatments.

Select...

I am 18 years old or older.

Select...

I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 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

Disease Control Rate (DCR)

Secondary outcome measures

Duration of Response (DOR)

Evaluation of safety and tolerability of surufatinib

Maximum plasma concentrations of surufatinib with blood sampling

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: SurufatinibExperimental Treatment1 Intervention

Cohorts A, B, and C: oral surufatinib 300 mg once daily in treatment cycles of 28 days starting at Cycle 1 Day1 Cohort D: Surufatinib 300 mg once daily in treatment cycles of 28 days starting at Cycle 1 Day and single doses of drug cocktail on Day-2 and Day 15 Cycle 1

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Surufatinib

2021

Completed Phase 3

~820

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

HutchmedLead Sponsor

27 Previous Clinical Trials

5,268 Total Patients Enrolled

2 Trials studying Neuroendocrine Tumors

135 Patients Enrolled for Neuroendocrine Tumors

Hutchison Medipharma LimitedLead Sponsor

100 Previous Clinical Trials

13,471 Total Patients Enrolled

6 Trials studying Neuroendocrine Tumors

666 Patients Enrolled for Neuroendocrine Tumors

John Kauh, MDStudy DirectorHutchmed

7 Previous Clinical Trials

374 Total Patients Enrolled

3 Trials studying Neuroendocrine Tumors

171 Patients Enrolled for Neuroendocrine Tumors

Media Library

Surufatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04579679 — Phase 2

Neuroendocrine Tumors Research Study Groups: Surufatinib

Neuroendocrine Tumors Clinical Trial 2023: Surufatinib Highlights & Side Effects. Trial Name: NCT04579679 — Phase 2

Surufatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04579679 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Where are the clinical trial sites for this research?

"The trial is based out of University of Alabama, Birmingham (UAB) in Birmingham, Alabama with other locations including University of California Irvine Medical Center UCIMC - H.H. Chao Comprehensive Digestive Disease Center CDDC in Orange, California and Stony Brook Cancer Center in Stony Brook, New york as well as 5 others."

Answered by AI

What are the associated risks of Surufatinib?

"Surufatinib's safety was given a score of 2 out of 3. This is due to the fact that, while there is some evidence indicating that Surufatinib is safe, there is no data currently supporting its efficacy in treating patients."

Answered by AI

Are people with the qualifying condition able to participate in this research project at this time?

"Yes, this clinical trial is looking for eligible participants. The listing on clinicaltrials.gov shows that the study was first posted on 8/13/2021 and has been updated as recently as 10/4/2022."

Answered by AI

Does Surufatinib have a history of being tested in other medical trials?

"There are a total of 23 clinical studies currently underway for Surufatinib. Out of these, 3 are in the final stage before approval (Phase 3). The vast majority of these trials are based in Beijing, but there are 97 locations across the world participating."

Answered by AI

How many people are allowed to be a part of this experiment?

"In order to move forward, this trial requires the recruitment of 76 patients that meet the pre-specified inclusion criteria. University of Alabama, Birmingham (UAB) in Birmingham, Alabama and University of California Irvine Medical Center UCIMC - H.H. Chao Comprehensive Digestive Disease Center CDDC are two examples of locations where patients can participate."

Answered by AI

Have there been any other scientific tests like this one previously?

"23 ongoing studies for Surufatinib are underway in 9 countries and 39 cities. The first study began in 2015 with 195 patients. Hutchison Medipharma Limited sponsored the Phase 3 approval process, which completed drug approval in 2015. 13 subsequent studies have been conducted since then."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Open-Label Surufatinib in European Patients With NET

2021. "Open-Label Surufatinib in European Patients With NET". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04579679.

All > Lung Cancer Anaheim