Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New pill shows promise for rare gut tumors

NCT ID NCT05077384

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Neuroendocrine tumors are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

  • Aichi Cancer Centre

    Nagoya, 464-8681, Japan

  • Fukuoka Sanno Hospital

    Fukuoka, 814-0001, Japan

  • Hokkaido University Hospital

    Sapporo, 060-8648, Japan

  • Kagawa University Hospital

    Kagawa, 761-0793, Japan

  • Kansia Electric Power Hospital

    Osaka, 553-0003, Japan

  • Kyorin University Hospital

    Mitaka, 181-8611, Japan

  • Kyoto University Hospital

    Kyoto, 606-8507, Japan

  • Kyushu University Hospital

    Fukuoka, 812-0054, Japan

  • National Cancer Centre Hospital

    Tokyo, 104-004, Japan

  • National Cancer Centre Hospital East

    Kashiwa-shi, 277-8577, Japan

  • Tohoku University Hospital

    Sendai, 890-8574,, Japan

  • Yokohama City University Hospital

    Yokohama, 236-0004, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.