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Cancer drug regorafenib gets a second chance in small continuation study

NCT ID NCT06246643

Disease control Sponsor: Bayer Source: ClinicalTrials.gov ↗

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 27, 2026 · Updated 4 times

Summary

This study allows people with solid tumors who are already taking the cancer drug regorafenib in another Bayer study to keep taking it after that study ends. The goal is to see how safe and tolerable the continued treatment is. Only 13 participants are enrolled, and they take the same dose they were on before. Researchers will track side effects and any dose changes needed.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
regorafenib (Stivarga)
What this could lead to
If successful, this study could show that continuing regorafenib is safe and tolerable for people with solid tumors who already benefit from it.
What could go wrong
This is a very small, early-phase study with only 13 participants, so results may not apply widely. Regorafenib can cause side effects like fatigue, liver issues, and bleeding.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 13 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Apr 2028

An estimate. End dates often move.

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

10 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.

Inclusion Criteria: * Participant is currently participating in any Bayer-sponsored regorafenib study and is receiving regorafenib as study treatment. * Participant is currently benefiting from treatment with regorafenib monotherapy. All participants must meet criteria to initiate a subsequent cycle of therapy, as determined by the guidelines of the feeder protocol. * Any ongoing adverse events that require temporary treatment interruption must be resolved to baseline grade or assessed as stable and not requiring further treatment interruption by the investigator. Exclusion Criteria: * Ineligibility, for medical reasons, to start the subsequent cycle in the respective feeder study. * Participants with a beta-human chorionic gonadotropin (hCG) test result consistent with pregnancy. * Participants are using one or more of the prohibited medications listed in the respective feeder study protocol. * Participant has been previously permanently discontinued from regorafenib treatment.

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Conditions

The condition(s) this trial relates to.

cancer neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Solid malignant tumors

Contacts and locations

Locations

  • CHU Lille - Hopital Claude Huriez - Service Gastro-entrologie adulte

    Lille, 59000, France

  • China Medical University Hospital

    Taichung, 404327, Taiwan

  • Hospital Infantil Universitario Nino Jesus | Oncologia Pediatrica

    Madrid, 28009, Spain

  • Hôpital Beaujon - Clichy

    Clichy, Île-de-France Region, 92110, France

  • Hôpital Paul Brousse - Villejuif

    Villejuif, Île-de-France Region, 94800, France

  • Saitama Cancer Center

    Kitaadachi, Saitama, 362-0806, Japan

  • Seoul National University Hospital | Oncology

    Seoul, 03080, South Korea

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