臨床研究等提出・公開システム

Phase 2 Study of Futibatinib 20 mg and 16 mg in Patients with Advanced Cholangiocarcinoma with FGFR2 Fusions or Rearrangements (FOENIX-CCA4)

Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement (FOENIX-CCA4)

Elsayed Hamdy

Taiho Pharmaceutical Co., Ltd.

1-27 Kandanishiki-cho, Chiyoda-ku, Tokyo

th-TAS120-info@taiho.co.jp

Takebe Yoshitaka

Taiho Pharmaceutical Co., Ltd.

1-27 Kandanishiki-cho, Chiyoda-ku, Tokyo

+81-3-3293-2113

th-TAS120-info@taiho.co.jp

Recruiting

June. 14, 2023

Interventional

randomized controlled trial

open(masking not used)

dose comparison control

parallel assignment

treatment purpose

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, unresectable iCCA or eCCA who had documented evidence of FGFR2 gene fusions or other rearrangements using next generation sequencing (NGS) or fluorescence in situ hybridization (FISH)
2. Received at least one prior systemic gemcitabine and platinum-based regimen for CCA.
3. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1, 2009)
4. Documentation of radiographic disease progression on the most recent prior therapy
5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
6. Adequate organ function

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 or systemic mineral imbalance with ectopic calcification of soft tissues (except commonly observed calcifications in soft tissues such as the skin, kidney, tendons, or vessels due to injury, disease, and aging in the absence of systemic mineral imbalance)
2. Current evidence of clinically significant retinal disorder as confirmed by ophthalmological examination
3. Treatment with any of the following within the specified time frame prior to the first dose of futibatinib:
- Major surgery within the previous 4 weeks (the surgical incision should be fully healed prior to the first dose of futibatinib)
- Radiotherapy for extended field within 4 weeks or limited field radiotherapy within 2 weeks
- Patients with locoregional therapy, eg, transarterial chemoembolization (TACE), selective internal radiotherapy (SIRT) or ablation within 4 weeks
- Any noninvestigational anticancer therapy within 3 weeks or have not recovered from side effects of such therapy prior to futibatinib administration (mitomycin within prior 5 weeks). Endocrine therapy is allowed for patients with breast or prostate cancer
- Targeted therapy or immunotherapy within 3 weeks or within 5 half lives (whichever is shorter)
- Any investigational agent received within 5 half-lives of the drug or 4 weeks, whichever is shorter. Concurrent participation in an observational study may be allowed after review by the Sponsor's Medical Monitor.
- Patients with prior FGFR-directed therapy
4. A serious illness or medical condition(s) including (but not limited to) the following:
- Known brain metastasis unless patient is clinically stable for >= 1 month
- Known acute systemic infection
- Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure; if >2 months, cardiac function must be within normal limits and the patient must be free of cardiac-related symptoms
- Significant gastrointestinal disorder(s) that could interfere with the absorption of futibatinib
- 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.
6. Exceptions must be discussed with the Sponsor prior to patient enrollment.
Pregnant or lactating female
7. Known hypersensitivity or severe reaction to futibatinib or its excipients

Both

Advanced Cholangiocarcinoma Harboring FGFR2 Gene Fusion or Rearrangements

Patients will receive futibatinib at an oral dose of 20 mg or 16 mg, administered QD on a 21 day cycle.

Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by BICR

+81-6-6645-2121

June. 02, 2023

No

IPD data will not be shared according to the Sponsor policy on data sharing. Taiho clinical trial information disclosure policy may be found at https://www.taiho.co.jp/en/science/policy/clinical_trial_information_disclosure_policy/index.html

United States