EUCTR2007-005017-19-IT进行中（未招募）1 期
Open-label, multi-center, randomized, two stage adaptive design study of the combination of bevacizumab with standard chemotherapy in minor patients with metastatic rhabdomyosarcoma, non-rhabdomyosarcoma soft-tissue sarcoma or Ewing?s sarcoma/soft-tissue primitive neuroectodermal tumors - BERNIE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- ROCHE
- 入组人数
- 154
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. Written informed consent of patient/parent/legally acceptable representative (latest approved version by the Independent Ethics Committee [IEC]/Institutional Review Board [IRB]), obtained prior to any study-specific procedures. 2. Age prior to treatment start ≥ 2 years and ≤ 17 years. 3. Newly diagnosed, histologically documented, patients with one of the following diseases: Metastatic Rhabdomyosarcoma (RMS). Risk factors:Bone or bone marrow involvement (considered as 1 site). More than two different organs with metastatic disease. Unfavorable primary sites: extremities (including buttocks and shoulder) and trunk. At least two of the RMS specific risk factors are required for the 1st stage of the study. Metastatic non-rhabdomyosarcoma soft-tissue sarcoma (NRSTS). Metastatic Ewing?s sarcoma (ES)/soft-tissue primitive neuroectodermal tumor (PNET) Risk factors: Bone metastases. Bone marrow metastases. At least one of these ES/PNET specific risk factors is required for the 1st stage of the study. 4. Age-adapted performance status and life expectancy adequate for chemotherapy according to the protocol. 5. Adequate bone marrow function: Absolute neutrophil count (ANC) ≥ 1.0 x 109/L and WBC ≥ 2.0 x 109/L. Platelet count ≥ 100 x 109/L (in case of bone marrow involvement ≥ 75 x 109/L). Hb > 7.5 g/dL (75 g/L - including after transfusion). 6. Adequate blood clotting: PT-INR ≤ 1.5 and aPTT ≤ 1.5 x upper limit of normal (ULN) within 7 days prior to treatment start. 7. Adequate liver function: Serum (total) bilirubin ≤ 1.5 x ULN. AST and ALT ≤ 2.5 x ULN in patients without liver metastases, ≤ 5 x ULN in patients with liver metastases. 8. Adequate renal function: Serum creatinine < 1.5 x ULN for age; If serum creatinine is > 1.5 x ULN for age, the creatinine clearance (or radioisotope GFR) must be > 70 mL/min/1.73 m2. Urine dipstick < 2+ for proteinuria. Patients who have ≥ 2+ of proteinuria on dipstick urinalysis should undergo a 24 hour urine collection; children and adolescents ≤ 12 years must have ≤ 500 mg of protein/24 hours and patients > 12 years must have ≤ 1 g of protein/24 hours. No clinical evidence of nephrotic syndrome. 9. Adequate cardiac function (Shortening Fraction (SF) ≥ 28%) at screening, as determined by echocardiography; no evident and clinically significant symptoms of CHF (must be < class II of classification for heart failure (New York Heart Association (NYHA) or Ross scale).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Previous malignant tumors. 2. Prior systemic anti-tumor treatment. 3. Evidence of symptomatic spinal cord compression, CNS or brain metastases; patients must undergo a MRI or CT scan of the brain and/or spine in case of suspected brain metastatic disease. 4. Tumor invading major blood vessels (CT scan based evidence); the investigator or radiologist must excludeor extending into the lumen of a major blood vessel (e.g. pulmonary artery or superior vena cava). 5. Major surgical procedures or anticipation of the need for major surgery (other than the standard per protocol surgery) between screening and the first safety follow-up visit is considered incompatible with the use of bevacizumab; minor surgical procedures, including biopsy similar to and including central venous access device placement, within less than 7 days prior to randomization, or anticipated treatment start before the wound has healed. 6. Documentation of clinically evident non-healing wound (as determined by the investigator), peptic ulcer or bone fracture. 7. Current or recent (within 30 days prior to study start) treatment with another investigational drug or participation in another investigational study. 8. Increased risk of gastrointestinal, renal, bone marrow, or congenital bleeding disorders. 9. History or evidence of severe uncontrolled intercurrent illness at study entry, e.g. Uncontrolled seizures. Any bleeding or clotting diathesis, e.g. venous or arterial thromboembolic events (VTE, ATE), pulmonary embolism (PE). Any clinically significant (i.e. active) cardiovascular disease, e.g. cerebrovascular accidents (CVAs)/stroke, myocardial infarction (MI), transient ischemic attacks (TIAs), unstable angina, or severe cardiac arrhythmia; clinical evidence of arterial hypertension, specified as systolic and diastolic BP ≥ 95th percentile for age, gender and height (see Appendix 7). Any other disease, metabolic or psychological dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug, or places the patient at unacceptable risk from treatment complications. General or peripheral neuropathy ≥ grade 2 which is not induced by the underlying malignant disease. Uncontrolled infection. 10. Known hypersensitivity to: Any component of study drugs or ingredients. Chinese hamster ovary products or other recombinant human or humanized antibodies. 11. Ongoing (for ≥ 10 days prior to the 1st dose of study treatment) antithrombotic treatment, i.e. with aspirin or other platelet inhibitors, anticoagulants including thrombolytic agents, unfractionated or low-molecular-weight heparins, or coumarin-derived anticoagulants; well-controlled anticoagulation is permitted as primary prophylaxis against thromboembolic events (TEs) and/or for maintenance of patency of a central access venous device (CVAD). 12. Pregnancy and/or lactation: a negative serum pregnancy test in all female patients aged ≥ 12 years (to be confirmed by urine test if serum test was performed more than 7 days prior to treatment start) must be obtained before treatment start;fertile patients with potential to bear or father a child must use an effective method of contraception. et al.....
研究者
相似试验
进行中（未招募）
1 期
Open-label, multi-center, randomized, two stage adaptive design study of the combination of bevacizumab with standard chemotherapy in minor patients with metastatic rhabdomyosarcoma, non-rhabdomyosarcoma soft-tissue sarcoma or Ewing’s sarcoma/soft-tissue primitive neuroectodermal tumors.EUCTR2007-005017-19-FRF. Hoffmann-La Roche Ltd154
已完成
2 期
Phase II study of BSC-1 in patients with ATJPRN-jRCT2080224172Minophagen Pharmaceutical Co., Ltd.38
尚未招募
不适用
A two stage, randomized, multicentric, open-label, multiple dose, two-treatment, two-sequence, two-period, crossover, steady state bioequivalence study of test Nilutamide 150 Mg tablets with reference Nilandron 150 mg tabletsCTRI/2014/08/004909EirGen Pharma Ltd20
进行中（未招募）
2 期
Clinical trial to Evaluate Treatment Compliance, Efficacy and Safety of an Improved new formulation of Deferasirox in the form of Granules in children of the age 2 to 18 Years Old who have Iron overload.CTRI/2017/10/010252ovartis Healthcare Private Limited6
尚未招募
不适用
A Bioequivalence in Patients with Schizophrenia already receiving a stable Regimen of Paliperidone Palmitate Extended Release Injectable Suspension.CTRI/2021/06/034105Accord Healthcare Inc