Cancer drug futibatinib gets a safety check in Long-Term rollover study
NCT ID NCT06506955
First seen Jun 27, 2026 · Last updated Jul 29, 2026 · Updated 2 times
Summary
This study is for people with advanced or metastatic cancer who have already been taking futibatinib in a previous study and are still benefiting from it. The goal is to keep giving them the drug (alone or with fulvestrant) and watch for any side effects over a longer period. Only 15 participants are expected, and the study is open-label, meaning everyone knows what treatment they are getting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- futibatinib (alone or with fulvestrant)
- What this could lead to
- If successful, this study could show that long-term futibatinib treatment is safe and continues to control advanced cancer in patients who already responded.
- What could go wrong
- This is a very small rollover study (15 patients) with no control group, so results may not apply broadly. Side effects from long-term use are still being evaluated.
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 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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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
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Provide written informed consent. * Receiving futibatinib as monotherapy or as combination therapy in an antecedent futibatinib study and deriving clinical benefit with no undue risk as assessed by the investigator. * Women of childbearing potential (WOCBP) must have a negative pregnancy test (urine or serum) within 7 days prior to receiving treatment. Both males and females of reproductive potential must agree to use effective birth control during study treatment and for a specified time after the last dose of study treatment. * Ability to take medications orally (PO) (feeding tube is not permitted). Exclusion Criteria: • Has met any discontinuation criteria within the antecedent futibatinib study.
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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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Centro Integral Oncologico
Madrid, 28050, Spain
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Hospital Universitari, Vall d'Hebron
Barcelona, 8035, Spain
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Institut De Cancerologie Strasbourg
Strasbourg, 67033, France
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Institut Paoli-Calmettes
Marseille, 13009, France
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Royal Marsden NHS Foundation Trust
London, SW3 6JJ, United Kingdom
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Sarah Cannon Research Institute UK
London, W1G 6AD, United Kingdom
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Severance Hospital
Seoul, 3722, South Korea
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University College London Hospitals NHS Foundation Trust
London, W1T 7HA, United Kingdom
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University of California, San Francisco (UCSF)
San Francisco, California, 94143, United States
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