Neuroendocrine TumorsPhase 1/2NCT05077384
Open-label Study of Surufatinib in Japanese Patients
A Phase 1/2 study testing Surufatinib in people with Neuroendocrine Tumors and Non-hematologic Malignancy, run by Hutchmed at 12 sites in Japan.
Trial summary
This is a phase 1/2, open-label, multi-centre study of surufatinib in patients with unresectable, locally advanced, or recurrent nonhematologic malignancies who do not respond or are intolerant to standard of care. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Neuroendocrine Tumors, Non-hematologic Malignancy
- What is being tested?
- Surufatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 12 sitesJapan
- Study dates
- 2 Sep 2021to 17 Jan 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically documented disease as follows:
- Part 1: unresectable, locally advanced or metastatic nonhematologic malignancy that is relapsed/refractory to or intolerant of established therapies known to provide clinical benefit
- Part 2: locally advanced or metastatic, low (grade 1) or intermediate (grade 2) grade NETs that have been previously treated with at least 1 line of systemic therapy
- Has radiologic evidence of progressive tumour within 12 months of study enrolment
- Is willing and able to provide informed consent
- Is ≥20 years of age
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- Has measurable lesions according to RECIST Version 1.1
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Female patients of childbearing potential and male patients with partners of childbearing potential agree to use a highly effective form(s) of contraception
Who cannot join
- Women who are pregnant and lactating, or possibly pregnant.
- Has a history of interstitial lung disease (ILD)/noninfectious pneumonitis, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
- Known active viral hepatits
- Has an AE due to previous anti-tumour therapy that has not recovered to ≤CTCAE Grade 1, except alopecia and peripheral neurotoxicity with ≤CTCAE Grade 2 caused by platinum chemotherapy
- Uncontrollable hypertension, defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg, despite antihypertensive medication
- Gastrointestinal disease or condition within 6 months prior to first dose
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- Has a history or presence of a serious haemorrhage (>30 mL within 3 months) or haemoptysis (>5 mL blood within 4 weeks)
- 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.
- A high risk of bleeding at screening due to tumour invasion into major vessels, such as pulmonary artery, the superior vena cava, or the inferior vena cava, as determined by investigators.
- Has arterial thrombosis or deep venous thrombosis within 6 months prior to first dosing, or thromboembolic events (including stroke and/or transient ischaemic attack) within 12 months prior to first dosing.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Japan12 sites
Kyushu University Hospital
Fukuoka, 812-0054
Fukuoka Sanno Hospital
Fukuoka, 814-0001
Kagawa University Hospital
Kagawa, 761-0793
National Cancer Centre Hospital East
Kashiwa-shi, 277-8577
Kyoto University Hospital
Kyoto, 606-8507
Kyorin University Hospital
Mitaka, 181-8611
Aichi Cancer Centre
Nagoya, 464-8681
Kansia Electric Power Hospital
Osaka, 553-0003
Hokkaido University Hospital
Sapporo, 060-8648
Tohoku University Hospital
Sendai, 890-8574,
National Cancer Centre Hospital
Tokyo, 104-004
Yokohama City University Hospital
Yokohama, 236-0004
About this study
Official title: An Open-Label Study of Surufatinib in Japanese Patients With Neuroendocrine Tumors
This is a phase 1/2, open-label, multi-centre study of surufatinib in patients with unresectable, locally advanced, or recurrent nonhematologic malignancies who do not respond or are intolerant to standard of care.
Read the detailed description
The purpose of this study is to evaluate the tolerability and efficacy of surufatinib in Japanese patients.
The study will be conducted in 2 parts:
- Part 1 - evaluation of tolerability and safety of surufatinib and confirmation of the recommended clinical dose in Japanese patients with nonhematologic malignancies
- Part 2 - evaluation of antitumor activity and confirmation of tolerability of surufatinib in Japanese patients with NETs
All patients will be treated with oral surufatinib 300 mg QD in treatment cycles of 28 days starting on Cycle 1 Day 1.
- Conditions
- Neuroendocrine Tumors, Non-hematologic Malignancy
- Being tested
- Surufatinib
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurufatinibDrug
Also called HMPL-012, sulfatinib
Surufatinib 300 mg oral once daily
| Study group | Role | What they receive |
|---|---|---|
| Surufatinib | Experimental | Oral surufatinib 300 mg once daily in treatment cycles of 28 days starting at Cycle 1 Day1 Receives: Drug: Surufatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Incidence of treatment-emergent adverse events (TEAEs) graded by the Investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0).
To evaluate surufatinib-related adverse events in patients with NETs
Measured: Up to 2 years
Part 2: Objective response rate. This will be assessed on the proportion of participants with partial response or complete response as determined by the Investigator based on RECIST v1.1
The primary outcome of part 2 will be objective response rate in patients with NETs when treated with surufatinib
Measured: Up to 2 years
Secondary outcomes (3)
Observed plasma concentrations of surufatinib which will be assessed by the Cmax, tmax, AUC, Cmin and CL/F
Blood sampling will be taken to measure levels of the study drug
Measured: Up to 2 years
Progression Free Survival (PFS) which is defined as the time from randomization to the first occurrence of disease progression as determined by the investigator based on RECIST v1.1, or death from any cause, whichever occurs first
The duration between the enrollment date and the first disease progression (PD) or death (whichever comes first).
Measured: Up to 2 years
Duration of Response (DOR) which will be defined as the time from the first response to disease progression documented after treatment initiation or death, whichever occurs first. DOR will include CR, CR plus CRi, overall response (OR), and CR plus CRh.
The duration between the date the criteria for complete response or partial response was first measured (first record shall prevail) and the date of disease recurrence or progression as objectively recorded
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start2 Sep 2021
- Primary completion6 Sep 2024
- Study completion17 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by HutchmedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hutchmed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Schelman, MD, Study director, Hutchmed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05077384
- Sponsor's protocol ID
- 2020-012-00JP1
- Status last verified
- Sep 2025
- First submitted
- 20 Sep 2021
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study of Surufatinib in Japanese Patients With Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT05077384
- Acronym / sponsor ID
- 2020-012-00JP1
- Conditions
- Neuroendocrine Tumors, Non-hematologic Malignancy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- HutchmedIndustry (pharma, biotech, devices)
- Study start
- 2 Sep 2021 (actual)
- Primary completion
- 6 Sep 2024 (actual)
- Study completion
- 17 Jan 2025 (actual)
- First posted
- 14 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 1/2, open-label, multi-centre study of surufatinib in patients with unresectable, locally advanced, or recurrent nonhematologic malignancies who do not respond or are intolerant to standard of care.
Detailed description
The purpose of this study is to evaluate the tolerability and efficacy of surufatinib in Japanese patients.
The study will be conducted in 2 parts:
- Part 1 - evaluation of tolerability and safety of surufatinib and confirmation of the recommended clinical dose in Japanese patients with nonhematologic malignancies
- Part 2 - evaluation of antitumor activity and confirmation of tolerability of surufatinib in Japanese patients with NETs
All patients will be treated with oral surufatinib 300 mg QD in treatment cycles of 28 days starting on Cycle 1 Day 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surufatinib | Experimental | Drug: SurufatinibOral surufatinib 300 mg once daily in treatment cycles of 28 days starting at Cycle 1 Day1 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically or cytologically documented disease as follows:
- Has radiologic evidence of progressive tumour within 12 months of study enrolment
- Is willing and able to provide informed consent
- Is ≥20 years of age
- Has measurable lesions according to RECIST Version 1.1
Key exclusion criteria (11 listed)
- Women who are pregnant and lactating, or possibly pregnant.
- Has a history of interstitial lung disease (ILD)/noninfectious pneumonitis, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
- Known active viral hepatits
- Has an AE due to previous anti-tumour therapy that has not recovered to ≤CTCAE Grade 1, except alopecia and peripheral neurotoxicity with ≤CTCAE Grade 2 caused by platinum chemotherapy
- Uncontrollable hypertension, defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg, despite antihypertensive medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurufatinibAlso: HMPL-012, sulfatinibSurufatinib 300 mg oral once daily | Drug | Surufatinib |
Primary outcome
Part 1: Incidence of treatment-emergent adverse events (TEAEs) graded by the Investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0).
Time frame: Up to 2 years
To evaluate surufatinib-related adverse events in patients with NETs
Part 2: Objective response rate. This will be assessed on the proportion of participants with partial response or complete response as determined by the Investigator based on RECIST v1.1
Time frame: Up to 2 years
The primary outcome of part 2 will be objective response rate in patients with NETs when treated with surufatinib
3 secondary outcomes
Observed plasma concentrations of surufatinib which will be assessed by the Cmax, tmax, AUC, Cmin and CL/F
Time frame: Up to 2 years
Progression Free Survival (PFS) which is defined as the time from randomization to the first occurrence of disease progression as determined by the investigator based on RECIST v1.1, or death from any cause, whichever occurs first
Time frame: Up to 2 years
Duration of Response (DOR) which will be defined as the time from the first response to disease progression documented after treatment initiation or death, whichever occurs first. DOR will include CR, CR plus CRi, overall response (OR), and CR plus CRh.
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Schelman, MD study director
Hutchmed
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Surufatinib in people with Neuroendocrine Tumors and Non-hematologic Malignancy, run by Hutchmed at 12 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Incidence of treatment-emergent adverse events (TEAEs) graded by the Investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0). (time frame: Up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.