EUCTR2009-017957-37-FR进行中（未招募）1 期
A randomized, double-blind, placebo-controlled phase III study of regorafenib plus best supportive care versus placebo plus best supportive care for subjects with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease has progressed despite prior treatment with at least imatinib and sunitinib - BAY73-4506 Phase III GIST 3rd/4th line
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 170
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
入选标准
- •1.Signed informed consent obtained before any study specific procedures. Subjects must be able to understand and willing to sign a written informed consent.
- •2.Male or female subjects 18 years of age or older.
- •3.Subjects with histologically confirmed metastatic and/or unresectable GIST.
- •4.At least imatinib and sunitinib as prior treatment regimens, with objective disease progression or intolerance to imatinib, as well as disease progression while on sunitinib therapy. Additionally, disease progression or intolerance to other systemic therapies, as well as investigational new agents, is allowed, except prior treatment with any other vascular endothelial growth factor receptor (VEGFR) inhibitor.
- •5.Subjects must have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. A lesion in a previously irradiated area is eligible to be considered as measurable disease as long as there is objective evidence of progression of the lesion prior to study enrollment.
- •6.Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- •7.Adequate bone marrow, liver, and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment:
- •-Total bilirubin -Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) -Lipase -Serum creatinine -Glomerular filtration rate (GFR) >/= 30 ml/min/1.73 m2 according to the Modified Diet in Renal Disease (MDRD) abbreviated formula.
- •-International normalized ratio and partial thromboplastin time (INR and PTT) Subjects who are being treated with an anti-coagulant, such as warfarin or heparin, will be allowed to participate provided that no prior evidence of an underlying abnormality in these parameters exists. Close monitoring of at least weekly evaluations will be performed until INR and PTT are stable based on a pre dose measurement as defined by the local standard of care.
- •-Platelet count >/= 100000/mm3, hemoglobin (Hb) >/= 9.0 g/dl, absolute neutrophil count (ANC) >/=1500/mm3. Transfusion of subjects to meet the inclusion criteria will not be allowed.
- •-Alkaline phosphatase limit 8.Recovery to NCI-CTCAE v4.0 Grade 0 or 1 level or recovery to baseline preceding the prior treatment from any previous drug/procedure-related toxicity (except alopecia and anemia).
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Prior treatment with regorafenib. Subjects permanently withdrawn from study participation will not be allowed to re-enter the study.
- •2.Prior treatment with any vascular endothelial growth factor receptor (VEGFR) inhibitor except sunitinib.
- •3.Use of any approved tyrosine kinase inhibitors or investigational agents within 1 week or 6 half lives of the agent, whichever is shorter, prior to receiving study drug.
- •4.Cancer other than GIST within 5 years prior to randomization EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer, and superficial bladder tumors (Ta [Non invasive tumor], and Tis [Carcinoma in situ]).
- •5.Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication.
- •6.Pregnant or breast-feeding subjects. Women of childbearing potential not employing adequate contraception. Women of childbearing potential must have a pregnancy test performed a maximum of 7 days before start of study medication and a negative result must be documented before start of study medication.
- •Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) since signing of the informed consent form until at least 3 months after the last study drug administration. The definition of adequate contraception will be based on the judgment of the treating investigator or a designated associate.
- •7.Congestive heart failure New York Heart Association (NYHA) >/= class 2.
- •8.Unstable angina (angina symptoms at rest, new-onset angina, ie, within the last 3 months) or myocardial infarction (MI) within the past 6 months before start of study medication.
- •9.Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).
- •10.Uncontrolled hypertension (systolic blood pressure > 140 mmHg or diastolic pressure > 90 mmHg despite optimal medical management).
- •11.Subjects with pheochromocytoma.
- •12.Arterial thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), or pulmonary embolism within the 6 months before start of study drug.
- •13.Venous thrombotic events such as deep vein thrombosis within the 3 months before start of study drug
- •14.Ongoing infection > grade 2 National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
- •15.Known history of human immunodeficiency virus (HIV) infection.
- •16.Subjects with seizure disorder requiring medication.
- •17.Symptomatic metastatic brain or meningeal tumors
- •18.History of organ allograft.
- •19.Subjects with evidence or history of bleeding diathesis. Any hemorrhage or bleeding event >/= NCI-CTCAE version 4.0 grade 3 or higher within 4 weeks prior to the start of study drug.
- •20.Non-healing wound, ulcer, or bone fracture.
- •21.Renal failure requiring hemo- or peritoneal dialysis.
- •22.Dehydration NCI-CTCAE version 4.0 grade >/= 1.
- •23.Substance abuse or medical, psychological, or social conditions that may interfere with the subject’s participation in the study or evaluation of the study results.
研究者
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