New pill shows promise for rare gut tumors
NCT ID NCT05077384
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tested a daily pill called surufatinib in 36 Japanese patients with neuroendocrine tumors that had stopped responding to other treatments. The goal was to see if the drug is safe and whether it can shrink tumors. The trial combined an early safety phase with a later phase measuring tumor response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- surufatinib (a drug taken by mouth once daily)
- What this could lead to
- If successful, surufatinib could offer a new treatment option for patients with neuroendocrine tumors that have stopped responding to standard therapies.
- What could go wrong
- This is an early-phase study with only 36 participants, so results may not apply broadly. Side effects are possible, and the drug may not shrink tumors in all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
36 people
The number who actually took part.
- Started
-
Sep 2021
- Finished
-
Jan 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
20 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria: 1. Histologically or cytologically documented disease as follows: 1. Part 1: unresectable, locally advanced or metastatic nonhematologic malignancy that is relapsed/refractory to or intolerant of established therapies known to provide clinical benefit 2. 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 2. Has radiologic evidence of progressive tumour within 12 months of study enrolment 3. Is willing and able to provide informed consent 4. Is ≥20 years of age 5. Has measurable lesions according to RECIST Version 1.1 6. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 7. Female patients of childbearing potential and male patients with partners of childbearing potential agree to use a highly effective form(s) of contraception Key Exclusion Criteria: 1. Women who are pregnant and lactating, or possibly pregnant. 2. 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. 3. Known active viral hepatits 4. 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 5. Uncontrollable hypertension, defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg, despite antihypertensive medication 6. Gastrointestinal disease or condition within 6 months prior to first dose 7. Has a history or presence of a serious haemorrhage (\>30 mL within 3 months) or haemoptysis (\>5 mL blood within 4 weeks) 8. Clinically significant cardiovascular disease. 9. 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. 10. 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. 11. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Aichi Cancer Centre
Nagoya, 464-8681, Japan
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Fukuoka Sanno Hospital
Fukuoka, 814-0001, Japan
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Hokkaido University Hospital
Sapporo, 060-8648, Japan
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Kagawa University Hospital
Kagawa, 761-0793, Japan
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Kansia Electric Power Hospital
Osaka, 553-0003, Japan
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Kyorin University Hospital
Mitaka, 181-8611, Japan
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Kyoto University Hospital
Kyoto, 606-8507, Japan
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Kyushu University Hospital
Fukuoka, 812-0054, Japan
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National Cancer Centre Hospital
Tokyo, 104-004, Japan
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National Cancer Centre Hospital East
Kashiwa-shi, 277-8577, Japan
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Tohoku University Hospital
Sendai, 890-8574,, Japan
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Yokohama City University Hospital
Yokohama, 236-0004, Japan
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Swiss registry aims to map rare neuroendocrine tumors
- Can patients drop monthly injections after targeted radiotherapy for neuroendocrine tumors?
- Can a vast image library unlock better pancreatic diagnoses?
- Can a sharper PET tracer light up hidden neuroendocrine tumors?
- Can patient records reveal who will respond to neuroendocrine tumor treatments?
- Can a new drug formulation shrink Hard-to-Treat neuroendocrine tumors?