Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT02052778) enrolled participants across three stages: a dose-escalation phase (Phase 1), a dose-expansion phase (also Phase 1), and a Phase 2 portion. In the dose-escalation stage, 96 people took part across 14 different dose groups, testing a drug called TAS-120 (also known as futibatinib) at varying amounts given either every other day or once daily. The dose-expansion stage enrolled a further 201 people across six cohorts and two sub-cohorts, and the Phase 2 stage enrolled 120 people (of whom 103 received treatment). Across all stages, the trial was measuring things such as the highest dose that could be given without too many serious side effects, the best dose to carry forward into later testing, and how many participants' tumours shrank or disappeared according to standard imaging criteria. The reported data shows that, in the once-daily dosing arm of the dose-escalation phase, the highest tolerable dose (known as the Maximum Tolerated Dose, or MTD — meaning the highest amount where fewer than one in three participants experienced serious pre-defined reactions in the first treatment cycle) was reported as 20 mg. This 20 mg daily dose was also reported as the recommended dose to take forward into Phase 2 testing. For the every-other-day dosing arm, the reported data shows that an MTD figure was not determined (recorded as "NA" — not available). The reported data for the percentage of participants whose tumours shrank or disappeared (called "objective response") across the dose-expansion cohorts and the Phase 2 portion was not fully included in the data provided to summarise here, so those specific figures cannot be reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 38884254) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 2 Stomach Cancer Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You are 18 years of age or older
- You have been diagnosed with cancer that has spread or cannot be surgically removed, confirmed by a lab test on a tissue or cell sample
- You are willing and able to sign a consent form agreeing to take part
- Your cancer has continued to grow or spread after standard treatments, or you were unable to tolerate those treatments
- You are generally well enough to carry out daily activities with little or no limitation (confirm with trial site)
- Your heart, liver, kidneys, and other organs are working well enough to take part (confirm with trial site)
Additional requirements depending on which part of the trial you join:
- Early dosing phase (any solid tumour): You have any type of solid tumour that has not responded to standard treatments
- Expansion phase: Your cancer has a specific change in a gene called FGF or FGFR; you have at least one area of cancer that can be measured on a scan; your cancer is one of several specific types including bile duct cancer, brain tumours, bladder cancer, breast cancer, gastric (stomach) cancer, or other solid tumours with certain gene changes
- Phase 2: You have a specific type of bile duct cancer (inside the liver) with a particular gene rearrangement called FGFR2; you have already received at least one chemotherapy treatment containing gemcitabine and a platinum-based drug; your scans show the cancer has grown; and you have never previously taken an FGFR inhibitor drug
Who may not be able to join:
- You have, or have had, significant problems with how your body manages calcium and phosphorus levels (confirm with trial site)
- You have, or have had, abnormal calcium deposits forming in parts of your body where they should not be (confirm with trial site)
- You have, or have had, a significant eye or vision problem affecting the retina (the back of the eye)
- You have another serious illness or medical condition that could affect your safety in the trial (confirm with trial site)
- You are currently pregnant or breastfeeding
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
1 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Phase 1: Dose Escalation-Maximum Tolerated Dose (MTD); Phase 1: Dose Escalation-Recommended Phase 2 Dose (RP2D) of TAS-120; Phase 1: Dose Expansion: Percentage of Participants With Objective Response; Phase 2: Percentage of Participants With Objective Response
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.