EUCTR2010-019121-34-ES进行中（未招募）1 期
An Open-Label, Dose-escalation, Phase I/IIa Study to Determine the Maximum Tolerated Dose, Recommended Dose, Efficacy, Pharmacokinetics, and Pharmacodynamics of the dual VEGFR-FGFR Tyrosine Kinase Inhibitor, E-3810, Given Orally as Single Agent to Patients With Advanced Solid Tumours - ND
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 130
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. Age ? 18 years
- •2. Histologically or citologically confirmed, locally advanced or metastatic solid tumour, relapsed or refractory to standard therapy.
- •In addition, only for the dose-expansion phase:
- •i) solid tumour bearing FGFR1 amplification and, if breast cancer, with at least one prior endocrine therapy in the metastatic setting if ER+, and at least one chemotherapy line otherwise
- •ii) solid tumour progressing after having experienced SD (lasting for at least six month) or PR as best response to prior treatment with an approved or investigational antiangiogenic drug (e.g.: sorafenib, sunitinib, bevacizumab) as a single agent or in a chemotherapy combination
- •iii) solid tumour potentially sensitive to antiangiogenic treatments provided no antiangiogenic agents are approved and\or available for that specific condition.
- •3. Life expectancy ? 3 months
- •4. Full recovery (to Grade ? 1) from any prior surgical procedure(s) and from reversible side effects of prior therapy for cancer including radiation therapy, chemotherapy, and immunotherapy
- •5. Adequate haematologic function (haemoglobin ? 9 g/dL, absolute neutrophil count [ANC] ? 1500/mL, platelets ? 100,000/mL), adequate renal function (serum creatinine < 1.5 mg/dL or creatinine clearance > 40 mL/min), and adequate hepatic function (serum bilirubin ? 1.5 x upper limit of normal (ULN) mg/dL, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ? 3 x ULN)
- •6. Eastern Co-operative Oncology Group (ECOG) performance status ? 1
- •7. Negative serum pregnancy test at screening in women of child bearing potential
- •8. For men and women of child-bearing potential, use of a medically accepted method of contraception (abstinence, barrier method with spermicide, intrauterine device, or steroidal contraceptive for women and barrier method for men) for the duration of the study and for 60 days after participation in the study
- •9. Willingness and ability to give written informed consent and to comply with study procedures
- •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 86
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 44
排除标准
- •1. Active central nervous system (CNS) metastases not controlled by prior surgery or radiotherapy and/or low dose steroids
- •2. Haematologic malignancies (including leukaemia of any form, lymphoma, and multiple myeloma)
- •3. Active second malignancy or history of another malignancy within 2 years, with the exception of non-melanoma skin cancers or carcinoma in situ (CIS) of the breast or cervix or controlled, superficial carcinoma of the bladder
- •4. Treatment with any anticancer agent within 3 weeks, including investigational agents, chemotherapy, immunotherapy, biologic or hormonal therapy, surgery or radiation therapy (6 weeks for nitrosoureas, mitomycin or bevacizumab); luteinizing hormone releasing hormone (LHRH) agonist for prostate and mitotane for adrenal carcinoma are allowed.
- •5. Significant cardiovascular disease or condition, including:
- •- Congestive heart failure requiring therapy
- •- Ventricular and/or supra-ventricular arrhythmia requiring therapy
- •- Severe conduction disturbance (including QTc interval prolongation > 0.47 sec [corrected], history of severe arrhythmia, or history of familial arrhythmia [e.g., Wolff-Parkinson-White syndrome])
- •- Angina pectoris requiring therapy
- •- Left ventricular ejection fra-tion (LVEF) < 50% evaluated by cardiac ultrasound (ECHO) or Multi Gated Acquisition Scan (MUGA)
- •- Uncontrolled hypertension (defined as systolic blood pressure ? 140 mm Hg and/or diastolic blood pressure ? 90 mm Hg with optimized antihypertensive therapy)
- •- Myocardial infarction (MI) within 6 months prior to administration of the first dose
- •- > Class I cardiovascular disease according to the New York Heart Association's (NYHA) Functional Criteria
- •6. Ongoing treatment with Warfarin
- •7. Unavoidable concomitant treatment with any drug known for potential risk of causing Torsades de Pointes (see list in Appendix 4)
- •8. Significant gastrointestinal abnormalities, including ulcerative colitis, chronic diarrhoea associated with intestinal malabsorption, Crohn's disease, and/or prior surgical procedures affecting absorption or requirement for intravenous (IV) alimentation
- •9. Known pre-existing clinically significant disorder of the hypothalamic-pituitary axis, thyroid and adrenal gland
- •10. Serious/active bacterial, viral or fungal infection (including known active human immunodeficiency virus [HIV] infection) requiring systemic treatment
- •11. Concurrent severe or uncontrolled medical disease or organ system dysfunction which, in the opinion of the Investigators, would limit life expectancy to < 3 months, compromise the patient's safety, or interfere with evaluation of the safety of the investigational product
- •12. Psychiatric disorder or altered mental status that would preclude understanding of the informed consent process and/or completion of the necessary study procedures
- •13. Known hypersensitivity to gelatin or lactose monohydrate
- •14. Difficulty with swallowing
- •15. Pregnant or lactating women.
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