BridgeMD
FOENIX-CCA4
EU CTIS ID: 2023-503665-39-00
What this study is testing
To assess the efficacy of futibatinib administered at 20 mg and 16 mg QD to verify and describe the clinical benefit
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- A patient must meet all of the following inclusion criteria to be eligible for participation in this study: 1. Histologically or cytologically confirmed, locally advanced, metastatic, or unresectable intrahepatic of extrahepatic Cholangiocarcinoma.
- 2. Documented evidence of FGFR2 gene fusions or other FGFR2 rearrangement Received at least one prior systemic gemcitabine and platinum-based regimen for CCA
- 3. Documentation of radiographic disease progression on the most recent prior therapy Measurable disease performance status 0 or 1 Adequate organ function
- 4. Documentation of radiographic disease progression on the most recent prior therapy
- 5. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1, 2009)
- 6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
You likely can't join if
- A patient must not meet any of the following exclusion criteria to be eligible for participation in this study: 1. History or current evidence of calcium and phosphate homeostasis disorder
- 2. Current evidence of clinically significant retinal disorder
- 3. Treatment with any of the following within the specified time frame prior to the first dose of futibatinib: a. Major surgery within the previous 4 weeks (the surgical incision should be fully healed prior to the first dose of futibatinib) and radiotherapy for extended field within 4 weeks or limited field radiotherapy within 2 weeks b. Patients with locoregional therapy, eg, transarterial chemoembolization (TACE), selective internal radiotherapy (SIRT) or ablation within 4 weeks c. Any noninvestigational anticancer therapy within 3 weeks or have not recovered from side effects of such therapy prior to futibatinib administration. Endocrine therapy is allowed for patients with breast or prostate cancer d. Targeted therapy or immunotherapy within 3 weeks or within 5 half lives (whichever is shorter) e. Any investigational agent received within 5 half-lives of the drug or 4 weeks, whichever is shorter. g. Patients with prior FGFR-directed therapy
- 4. A serious illness or medical condition(s) including (but not limited to) the following: a. Known brain metastasis (not including primary brain tumors) unless patient is clinically stable for ≥1 month b. Known acute systemic infection c. Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure (New York Heart Association [NYHA] Class III or IV within the previous 2 months; if >2 months, cardiac function must be within normal limits and the patient must be free of cardiac-related symptoms d. Significant gastrointestinal disorder(s) that could interfere with the absorption of futibatinib e. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the judgment of the Investigator would make the patient inappropriate for entry into this study
- 5. Known additional malignancy that is progressing or requires active treatment, with the exception of patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or antitumor assessment of the investigational regimen. Exceptions must be discussed with the Sponsor prior to patient enrollment.
- 6. Pregnant or lactating female
See the full eligibility criteria
Who can join
- A patient must meet all of the following inclusion criteria to be eligible for participation in this study: 1. Histologically or cytologically confirmed, locally advanced, metastatic, or unresectable intrahepatic of extrahepatic Cholangiocarcinoma.
- 2. Documented evidence of FGFR2 gene fusions or other FGFR2 rearrangement Received at least one prior systemic gemcitabine and platinum-based regimen for CCA
- 3. Documentation of radiographic disease progression on the most recent prior therapy Measurable disease performance status 0 or 1 Adequate organ function
- 4. Documentation of radiographic disease progression on the most recent prior therapy
- 5. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1, 2009)
- 6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
What rules you out
- A patient must not meet any of the following exclusion criteria to be eligible for participation in this study: 1. History or current evidence of calcium and phosphate homeostasis disorder
- 2. Current evidence of clinically significant retinal disorder
- 3. Treatment with any of the following within the specified time frame prior to the first dose of futibatinib: a. Major surgery within the previous 4 weeks (the surgical incision should be fully healed prior to the first dose of futibatinib) and radiotherapy for extended field within 4 weeks or limited field radiotherapy within 2 weeks b. Patients with locoregional therapy, eg, transarterial chemoembolization (TACE), selective internal radiotherapy (SIRT) or ablation within 4 weeks c. Any noninvestigational anticancer therapy within 3 weeks or have not recovered from side effects of such therapy prior to futibatinib administration. Endocrine therapy is allowed for patients with breast or prostate cancer d. Targeted therapy or immunotherapy within 3 weeks or within 5 half lives (whichever is shorter) e. Any investigational agent received within 5 half-lives of the drug or 4 weeks, whichever is shorter. g. Patients with prior FGFR-directed therapy
- 4. A serious illness or medical condition(s) including (but not limited to) the following: a. Known brain metastasis (not including primary brain tumors) unless patient is clinically stable for ≥1 month b. Known acute systemic infection c. Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure (New York Heart Association [NYHA] Class III or IV within the previous 2 months; if >2 months, cardiac function must be within normal limits and the patient must be free of cardiac-related symptoms d. Significant gastrointestinal disorder(s) that could interfere with the absorption of futibatinib e. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the judgment of the Investigator would make the patient inappropriate for entry into this study
- 5. Known additional malignancy that is progressing or requires active treatment, with the exception of patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or antitumor assessment of the investigational regimen. Exceptions must be discussed with the Sponsor prior to patient enrollment.
- 6. Pregnant or lactating female
- 7. Known hypersensitivity or severe reaction to futibatinib or its excipients.
The study team makes the final eligibility decision.
Where it's taking place
- Argentina
- Korea, Republic of
- United States
- China
- Taiwan
- Japan
- Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Argentina; Korea, Republic of; United States; China; Taiwan; Japan and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.