CTRI/2015/03/005609已完成1 期
A Phase I/II Study of Sunitinib In Young Patients with Advanced Gastrointestinal Stromal Tumor
试验速览
- 阶段
- 1 期
- 状态
- 已完成
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
入选标准
- •Patients must meet all of the following inclusion criteria to be eligible for to commence study drug treatment into the study.
- •1.Histological diagnosis of GIST
- •2.Tumor tissue must be available to assess KIT, PDGFRA, and BRAF genotypes (for any of these genes where genotyping was not previously performed) and to assess succinate dehydrogenase (SDH) protein expression by immunohistochemistry.
- •3.Patients must have demonstrated disease progression or intolerance to imatinib mesylate; have GIST with non-mutant KIT (tumor genotyping may be performed prior to or during screening; patients with an indeterminate KIT genotype are eligible if genotyping performed during screening); or cannot obtain imatinib in their country.
- •4.Age 6 to <21 years;
- •5.Advanced, unresectable GIST for which there are no available options for treatment with curative intent as assessed by the investigator
- •6.Measurable (per Response Evaluation Criteria in Solid Tumors; RECIST version 1.1; or evaluable disease
- •7.Resolution of all acute toxic effects of prior cancer treatment, radiotherapy or surgical procedure to NCI CTCAE v4.0 grade <=1;
- •8.ECOG Performance Status 0 -2 (for patients >=11 years of age) or Lansky >=50% (for patients <11 years);
- •9.Adequate organ function determined within 14 days prior to enrollment, defined by:
- •Peripheral absolute neutrophil count (ANC) >=1500/μL;
- •Platelet count >= 100,000/μL;
- •Hemoglobin >= 10 g/dL;
- •Total bilirubin <=1.5 x upper limit of normal (ULN) for age;
- •ALT (SGPT) or AST (SGOT) <= 3 x ULN for age;
- •Serum albumin >= 2.0 g/dL;
- •Serum amylase and lipase <1.5 x ULN;
- •Serum creatinine based on age/gender as follows:
- •Age Maximum Serum Creatinine (mh/dL)
- •Male Female
- •6 to <10 years 1 1
- •10 to <13 years 1.2 1.2
- •13 to <16 years 1.5 1.4
- •>=16 years 1.7 1.4
- •The threshold creatinine values in this table were derived from the Schwartz formula for estimating GFR utilizing child length and stature data published by the CDC.
- •Blood Pressure (BP) < the 95th percentile for age, height and gender
- •Cardiac shortening fraction or ejection fraction greater than the lower limit of normal (LLN).
- •10.Evidence of a personally signed and dated informed consent (and where applicable, assent) document indicating that the patient (or a legal representative) has been informed of all pertinent aspects of the study;
- •11.Patients (including legal guardian for minors where applicable) who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures, including anticipated ability to swallow capsules;
- •12.Male and female patients of childbearing potential who are sexually active must agree to use a highly effective method of contraception throughout the study and for 30 days after the last sunitinib treatment. A patient is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
排除标准
- •1.Current treatment with another investigational agent and/or systemic anti-cancer therapy within 4 weeks before starting sunitinib treatment.
- •2.Prior sunitinib treatment;
- •3.Prior therapy with known risk for cardiovascular complications, eg, high intensity anthracycline therapy (ie, total equivalent cumulative dose 100 mg/m2 of doxorubicin) or prior radiation therapy that included the heart (cardiac silhouette) and/or craniospinal radiation;
- •4.Concomitant treatment with any drug having proarrhythmic potential (terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide and flecainide);
- •5.Prior diagnosis of cardiac disease, including, but not limited to:
- •Ongoing cardiac dysrhythmias of NCI CTCAE v4.0 >= grade 2, atrial fibrillation of any grade;
- •QTc interval 450 msec for males or 470 msec for females;
- •Hypertension that cannot be controlled by medications;
- •Any of the following within the 12 months prior to starting study treatment: congestive heart failure, cerebrovascular accident including transient ischemic attack or pulmonary embolism.
- •6.Grade >=3 hemorrhage within 4 weeks prior to first dose of study drug
- •7.Current treatment with therapeutic doses of coumarin-derivative anticoagulants such as warfarin or anti-vitamin K agents;
- •8.Concurrent administration of strong cytochrome P450-3A (CYP3A4) inhibitor(s) and/or inducer(s) within 7 and 12 days prior to first dose of study drug, respectively;
- •9.Prior radiation to 25% of the bone marrow.
- •10.Patients with history of allergic reaction attributed to any component of sunitinib capsules;
- •11.Pregnant females; breastfeeding females; males and females of childbearing potential not using highly effective contraception or not agreeing to continue highly effective contraception for 30 days after last dose of investigational product; in the UK, males and females of childbearing potential not using two (2) methods of highly effective contraception or not agreeing to continue two (2) methods of highly effective contraception for 30 days after last dose of investigational product;
- •12.Active infection with HIV, or receiving antiretroviral therapy for HIV disease;
- •13.Patients who are investigational site staff members or relatives of those site staff members or patients who are Pfizer employees directly involved in the conduct of the trial;
- •14.Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product 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
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