NL-OMON52381尚未招募3 期
A Phase 3, Open-Label, Randomized Study of Futibatinib Versus Gemcitabine-Cisplatin Chemotherapy as First-Line Treatment of Patients with Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements - FOENIX-CCA3
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Provide written informed consent.
- •2. Is >18 years of age (or meets the country*s regulatory definition for legal
- •adult age).
- •3. The patient has histologically confirmed, locally advanced, or metastatic,
- •or recurrent unresectable iCCA harboring FGFR2 gene rearrangements based on
- •testing performed by the designated central laboratory.
- •4. Patient has radiographically measurable disease per RECIST 1.1.
- •5. Patients who have received treatment for locally advanced disease (for
- •example, trans-arterial chemoembolization, selective internal radiation
- •therapy, external beam radiation) must have evidence of radiographic
- •progression with measurable disease outside the previously-treated lesions.
- •6. Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.
- •7. Adequate organ function as defined by the following criteria:
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 3.0
- •×upper limit of normal (ULN); if liver function abnormalities are due to
- •underlying liver metastasis, AST and ALT <= 5 × ULN.
- •Total bilirubin <= 1.5 × ULN, or <= 3.0 × ULN for patients with Gilbert*s
- •White Blood Count (WBC) >= 2000/mm3 (>= 2.0 × 109/L)
- •Absolute neutrophil count (ANC) >= 1000/mm3 (ie, >= 1.0 × 109/L by
- •International Units [IU])
- •Platelet count >= 100,000/mm3 (IU: >= 100 × 109/L)
- •Hemoglobin >= 9.0 g/dL
- •Phosphorus <= 1.5 × ULN
- •Creatinine clearance: >= 60 mL/min
- •8. Women of child-bearing potential (WOCBP) must have a negative serum
- •pregnancy test within 7 days prior to administration of the first dose of
- •futibatinib. Female patients are not considered to be of child bearing
- •potential if they have a history of hysterectomy or are post menopausal defined
- •as no menses for 12 months without an alternative medical cause. Both males and
- •females of reproductive potential must agree to use effective birth control
- •during the study prior to the first dose and for 3 months after the last dose.
- •9. Willing and able to comply with scheduled visits and study procedures.
排除标准
- •1. Patient has received previous systemic anticancer therapy.
- •Patients receiving adjuvant or neoadjuvant treatment and completed >=6 months
- •prior to randomization are eligible.
- •2. Patient has mixed hepatocellular carcinoma - iCCA disease.
- •3. History and/or current evidence of any of the following disorders:
- •Non-tumor related alteration of calcium-phosphorus homeostasis that is
- •clinically significant in the opinion of the Investigator.
- •Ectopic mineralization/calcification, including but not limited to soft
- •tissue, kidneys, intestine, or myocardia and lung, considered clinically
- •significant in the opinion of the Investigator.
- •Retinal disorder confirmed by retinal examination and considered clinically
- •significant in the opinion of the ophthalmologist.
- •4. History or current evidence of uncontrolled ventricular arrhythmias
- •5. Fridericia*s corrected QT interval (QTcF) > 470 ms on electrocardiogram
- •(ECG) conducted during Screening.
- •6. Treatment with any of the following within the specified time frame prior to
- •the first dose of study therapy, or failure to recover from side effects of
- •these prior therapies:
- •Major surgery within the previous 4 weeks (the surgical incision should be
- •fully healed prior to the first dose of study therapy).
- •Radiotherapy (any dose) for extended field within 4 weeks or limited field
- •radiotherapy within 2 weeks, and/or has not recovered from acute impact of
- •radiotherapy.
- •Patients with locoregional therapy, eg, transarterial chemoembolization
- •(TACE), selective internal radiotherapy (SIRT) or ablation within 4 weeks.
- •Any history of liver transplant.
- •7. A serious illness or medical condition(s) including, but not limited to, the
- •Brain metastases that are untreated or clinically or radiologically unstable
- •(that is, have been stable for <1 month).
- •Known acute systemic infection.
- •Myocardial infarction, severe/unstable angina, or symptomatic congestive
- •heart failure within the previous 6 months.
- •Chronic nausea, vomiting, or diarrhea considered to be clinically significant
- •in the opinion of the Investigator.
- •Congenital long QT syndrome, or any known history of torsade de pointes, or
- •family history of unexplained sudden death.
- •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.
- •8. Patients with a history of another primary malignancy whose natural history
- •or treatment has the potential to interfere with the safety or efficacy
- •assessment of the investigational regimen in the opinion of the investigator.
- •9. Pregnant or breast-feeding female.
- •10. The patient is unable to take oral medication.
研究者
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