Futibatinib treatment for advanced cholangiocarcinoma with FGFR2 gene changes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, multinational Phase 2 study evaluates the safety and efficacy of two different doses of futibatinib in patients with advanced cholangiocarcinoma that have FGFR2 gene fusions or rearrangements. Participants will be randomized to receive either 16 mg or 20 mg of futibatinib daily for 21-day cycles. The study aims to confirm the clinical benefit of the drug in patients who have previously been treated for their condition. Patients will continue treatment until disease progression or other withdrawal criteria are met.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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
3. Received at least one prior systemic gemcitabine and platinum-based regimen for CCA
4. Documentation of radiographic disease progression on the most recent prior therapy
5. Measurable disease
6. performance status 0 or 1
7. Adequate organ function

Exclusion Criteria:

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:

   1. 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
   2. Patients with locoregional therapy, eg, transarterial chemoembolization (TACE), selective internal radiotherapy (SIRT) or ablation within 4 weeks
   3. Any non investigational anticancer therapy within 3 weeks or have not recovered from side effects of such therapy prior to futibatinib. Endocrine therapy is allowed for patients with breast or prostate cancer
   4. Targeted therapy or immunotherapy within 3 weeks or within 5 half lives Any investigational agent received within 5 half-lives of the drug or 4 weeks, whichever is shorter.
   5. Patients with prior FGFR-directed therapy
4. A serious illness or medical condition(s) including (but not limited to) the following:

   1. Known brain metastasis (not including primary brain tumors) unless patient is clinically stable for ≥1 month
   2. Known acute systemic infection
   3. Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure (New York Heart Association \[NYHA\] Class III or IV New York Heart Association \[NYHA\] Classification) 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
   4. Significant gastrointestinal disorder(s) that could interfere with the absorption of futibatinib.
   5. 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.

Where it's running

• Guangdong Provincial People's Hospitall
  Guangzhou, Guangdong, China Recruiting
• Harbin Medical University - Cancer Hospital
  Harbin, Heilongjiang, China Recruiting
• Jiangsu Provance Hospital
  Nanjing, Jiangsu, China Recruiting
• Jilin Cancer Hospital
  Changchun, Jilin, China Recruiting
• Shandong University - Shandong Cancer Hospital
  Jinan, Shandong, China Recruiting
• Zhongahan Hospital Fudan unversity
  Shanghai, Shanghai Municipality, China Recruiting

+15 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Taiho Oncology, INC
• Email: medicalinformation@taihooncology.com
• Phone: +1 844-878-2446

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.