EUCTR2013-004810-16-ES进行中（未招募）1 期
A dose-finding Phase 1 study of TAS-120 in patients with advanced solid tumors with or without Fibroblast Growth Factor/Receptor (FGF/FGFR)-related abnormalities followed by a Phase 2 study in patients with advanced solid tumors or multiple myeloma with FGF/FGFR-related abnormalities
Taiho Pharma USA, Inc.0 个研究点目标入组 835 人开始时间: 2014年2月26日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 835
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Provide written informed consent.
- •2. Age of 18 years or over.
- •3. Phase 1 Dose Escalation:
- •Patients with histologically or cytologically confirmed advanced, measurable or non-measurable (as defined by Response Evaluation Criteria in Solid Tumors [RECIST] guidelines [version 1.1, 2009]) metastatic solid tumor(s) who have failed all standard therapies or for whom standard therapy does not exist. Starting with Dose Level 5 of each dosing schedule, only patients with locally diagnosed amplification, mutation, translocation or other associated abnormalities of FGF/FGFR will be enrolled (see Section 8.12, Pharmacogenomic (FGF/FGFR) Analysis).
- •6. Able to take medications orally (eg, no feeding tube).
- •7. Adequate organ function as defined by the following criteria:
- •a. 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.
- •b. Total serum bilirubin <= 1.5 × ULN.
- •c. Absolute neutrophil count >= 1 500/mm3 (ie, >= 1.5 × 109/L by International Units [IU]) (excluding measurements obtained within 7 days after administration of granulocyte colony-stimulating factor [G-CSF]).
- •d. Platelet count >= 100 000/mm3 (IU: >= 100 × 109/L) (excluding measurements obtained within 7 days after a transfusion of platelets).
- •e. Hemoglobin >= 8.0 g/dL (excluding measurements within 4 weeks of a transfusion of packed red blood cells [RBCs] or whole blood).
- •f. Serum Phosphorus <= ULN
- •g. Serum Calcium <= ULN
- •8. Creatinine < 1.5 × ULN.
- •9. Women of child-bearing potential must have a negative pregnancy test (urine or serum) within 7 days prior to administration of the first dose of TAS-120. Both males and females of reproductive potential must agree to use adequate birth control during the study and for 6 months after the last dose of TAS-120. Female patients are not considered to be of child-bearing potential if they have a history of tubal ligation or hysterectomy or are post-menopausal with a minimum of 1 year without menses.
- •Phase 1 Expansion and Phase 2:
- •Patients with histologically or cytologically confirmed advanced, measurable (as defined by RECIST guidelines [version 1.1, 2009]), metastatic solid tumor(s) or multiple myeloma (with measurable disease as defined by International Myeloma Working Group [IMWG] criteriaFGF/FGFR for whom no available therapy is likely to convey clinical benefit.
- •Patients with multiple myeloma can be enrolled provided they have measurable disease as defined by at least 1 of the following criteria:
- •? Serum protein electrophoresis (SPEP) >= 1 g/dL of monoclonal protein in serum.
- •? Urine protein electrophoresis (UPEP) > 200 mg of monoclonal protein in urine (based on 24-hour urine).
- •? Serum free light chain (SFLC): involved free light chain (FLC) >= 10 mg/dL (>= 100 mg/L) AND abnormal kappa to lambda SFLC ratio.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 335
排除标准
- •1. History and/or current evidence of endocrine alteration of calcium-phosphorus homeostasis.
- •2. History and/or current evidence of ectopic mineralization/calcification including but not limited to soft tissue, kidneys, intestine, or myocardia and lung with the exception of calcified lymph nodes and asymptomatic arterial calcification.
- •3. Current evidence of corneal disorder/keratopathy including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjuctivitis, etc, confirmed by ophthalmologic examination.
- •5.QTc > 470 msec on ECG conducted during Screening period
- •6. Treatment with any of the following within the specified time frame prior to the first dose of TAS-120:
- •a. Major surgery within the previous 4 weeks (the surgical incision should be fully healed prior to the first dose of TAS-120).
- •b. Radiotherapy for extended field within 4 weeks prior to the first dose of TAS-120 or limited field radiotherapy within 2 weeks prior to the first dose of TAS-120.
- •c. Any noninvestigational anticancer therapy within 3 weeks prior to TAS-120 administration (mitomycin within prior 5 weeks).
- •d. Any medication administered within 7 days prior to first dose of TAS-120 that is known to affect QT interval or to be arrhythmogenic such as, but not limited to, the following drugs (http://creciblemeds.org/pdftemp/pdf/CompositeList.pdf):
- •i. Ondansetron
- •ii. Erythromycin
- •iii.Droperidol
- •iv. Halofantrine
- •e. Any investigational agent received either concurrently or within the previous 30 days.
- •7. A serious illness or medical condition(s) including, but not limited to, the following:
- •a. Known brain metastasis unless patient is clinically stable and off corticosteroids for >= 2 months.
- •b. Known leptomeningeal metastasis.
- •c. Known acute systemic infection.
- •d. Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure (New York Heart Association [NYHA] Class III or IV (see Appendix B, New York Heart Association [NYHA] Classification) within the previous 6 months; if > 6 months cardiac function must be within normal limits and the patient must be free of cardiac-related symptoms.
- •e. Chronic nausea, vomiting, or diarrhea considered to be clinically significant in the opinion of the investigator.
- •f. Known human immunodeficiency virus or acquired immunodeficiency syndrome-related illness, or a history of serum positivity to hepatitis B or C.
- •g. Congenital long QT syndrome, or any known history of torsade de pointes (TdP), or family history of unexplained sudden death.
- •h. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or TAS-120 administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
- •8. Pregnant or lactating female.
研究者
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