What side effects are associated with this type of intervention?

Common side effects of Tyrosine Kinase Inhibitors (TKIs) used in the treatment of Neuroendocrine Tumors (NETs), such as Surufatinib, Pazopanib, and Sorafenib, include gastrointestinal issues (diarrhea, nausea), dermatological reactions (hand-foot skin reaction, rash), fatigue, hypertension, and hepatotoxicity. Cardiovascular effects, such as decreased ventricular ejection fraction, and other serious adverse events like venous thromboembolism and pneumothorax, may also occur.

What prior FDA approvals exist?

The FDA has approved several treatments for Neuroendocrine Tumors (NETs) that are similar to Surufatinib. Notably, Everolimus and Sunitinib have been approved for the treatment of progressive, well-differentiated NETs. Everolimus targets the mTOR pathway, while Sunitinib is a TKI that inhibits multiple receptors, including VEGFR and PDGFR, which are involved in tumor angiogenesis. These approvals highlight the therapeutic potential of targeting angiogenesis and related pathways in NETs.

What other types of research exist?

Promising alternatives to Surufatinib for Neuroendocrine Tumors include Cabozantinib, which targets VEGFR, MET, and AXL, and has shown activity in medullary thyroid cancer. Vandetanib, another TKI targeting VEGFR, EGFR, and RET, is also a potential option. Additionally, Everolimus, an mTOR inhibitor, has demonstrated efficacy in NETs and could be considered as a novel alternative.

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Tyrosine Kinase Inhibitor

Surufatinib for Neuroendocrine Cancer

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

Must not have

Clinically significant cardiovascular disease

Brain metastases and/or spinal cord compression untreated with surgery and/or radiotherapy, and without clinical imaging evidence of stable disease (SD) for 14 days or longer; patients requiring steroids within 4 weeks prior to start of study treatment will be excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests surufatinib, an oral medication, in patients with specific types of neuroendocrine tumors. It aims to stop the cancer cells from getting the signals they need to grow. Surufatinib has shown promising results in patients with advanced 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.

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.

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

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My advanced NET has worsened after 1-3 treatments.

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I am 18 years old or older.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a serious heart condition.

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I have brain or spinal metastases not treated with surgery or radiotherapy, and they haven't been stable for over 14 days.

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I haven't had major surgery in the last 4 weeks or radiation therapy in the last 2 weeks.

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My tumor is invading major blood vessels, increasing my risk of bleeding.

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My high blood pressure is not controlled by medication.

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I am currently receiving IV treatment for a serious infection.

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I have previously received treatment targeting VEGF/VEGFR.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Disease Control Rate (DCR)

Secondary study objectives

Duration of Response (DOR)

Evaluation of safety and tolerability of surufatinib

Maximum plasma concentrations of surufatinib with blood sampling

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Neuroendocrine Tumors (NETs) include tyrosine kinase inhibitors (TKIs) like sunitinib and everolimus, which target pathways involved in tumor growth and angiogenesis. Surufatinib, a TKI targeting VEGFR, FGFR, and CSF-1R, inhibits vascular endothelial growth factor receptors (VEGFR), fibroblast growth factor receptors (FGFR), and colony-stimulating factor-1 receptor (CSF-1R). These pathways are crucial for tumor blood supply, growth, and immune evasion. By blocking these receptors, Surufatinib can reduce tumor vascularization, inhibit tumor growth, and modulate the immune environment, offering a targeted approach that can be more effective and potentially less toxic than traditional chemotherapy. This is particularly important for NET patients, as these tumors often rely on angiogenesis and specific growth signals for progression.

Emerging systemic treatment options in meningioma.New targeted agents in gastroenteropancreatic neuroendocrine tumors.Inhibition of RET activated pathways: novel strategies for therapeutic intervention in human cancers.