EUCTR2014-001379-29-IT进行中（未招募）1 期
A PHASE II OPEN LABEL SINGLE CENTER STUDY OF THE CLINICAL ACTIVITY AND SAFETY OF THE BRAF-V600 INHIBITOR DABRAFENIB (TAFINLAR) IN PREVIOUSLY TREATED PATIENTS WITH HAIRY CELL LEUKEMIA (HCL) CARRYING THE BRAF-V600E MUTATIO
Dipartimento di Medicina0 个研究点目标入组 10 人开始时间: 2014年4月16日最近更新:
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
- 入组人数
- 10
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. Male or female HCL patients = 18 years of age.
- •2. Proven diagnosis of HCL according to the morphological and immunophenotypic criteria (co-expression of CD11c/CD25/CD103 and/or positivity for annexin-A1) of the World Health Organization (WHO-2008) classification of lymphoid neoplasms, accompanied by the presence of the BRAF-V600E mutation as detected using a sensitive allele-specific polymerase chain reaction (AS-PCR).
- •3. Patients with HCL must fall in one of the following categories: i) patients whose disease is refractory to therapy with purine analogs (no complete nor partial response or relapse =1 year following treatment); ii) patients whose disease relapses after therapy with a purine analog (pentostatin or cladribine) =1 year and = 2 years after the first course or whenever after a second or later course (in case of concomitant bone marrow hypoplasia, i.e. =20% hematopoietic cells on histological analysis, patients are eligible whenever the relapse occurs after the first course of purine analog); iii) patients who relapse after treatment with a BRAF inhibitor (e.g., Vemurafenib or Dabrafenib) or with a MEK inhibitor (e.g., Trametinib), including those who participated to our previous Vemurafenib trial (HCL-PG01); iv) patients that, after at least two courses of therapy (at least one of which including a purine analogue), still manifest a significant residual disease in the bone marrow (=30% of leukemic hairy cells; see Appendix 1 for histological and immunohistological assessment); v) patients with HCL who manifest severe side effects from therapy with purine analogs (prolonged and profound myelosuppression and immunosuppression, infectious complications, renal failure, vasculitis and autoimmune hemolytic anemia) or are deemed by the investigator medically unfit for chemotherapy with purine analogs (for example because of very old age and/or significant comorbidities).
- •4. Any prior treatment (chemotherapy and/or immunotherapy) must have been completed at least 12 weeks prior to initiation of study medication, except if no response to this treatment is already manifestly evident earlier.
- •5. ECOG PS of 0-2.
- •6. Patients must have recovered from all side effects of their most recent treatment for HCL.
- •7. Adequate renal and liver function as defined by the following laboratory values performed within 7 days prior to first dose of Dabrafenib: serum creatinine =2 times the upper limit of normal (ULN); serum aspartate transaminase (AST) and serum alanine transaminase (ALT) =2.5 times ULN, alkaline phosphatase =2.5 times ULN and bilirubin =1.5 times the ULN. Higher values are acceptable if they are directly related to the disease.
- •8. Negative serum pregnancy test within 7 days prior to commencement of dosing in premenopausal women. Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for =1 year.
- •9. Fertile men and women must use an effective method of contraception during treatment and for at least 16 weeks (for men) and 4 weeks (for women) after completion of treatment as directed by their physician. Effective methods of contraception are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly (for example implants, injectables, or intrauterine devices). Oral contraceptives are not reliable due to potential drug-drug interaction. At the discretion of the investigator, acceptable methods of
排除标准
- •1. Patients with a previous malignancy within the past 2 years are excluded except for patients with treated and controlled basal or SCC of the skin or carcinoma in-situ of the cervix or melanoma (or other tumors) carrying a BRAF-V600E mutation. Isolated elevation in PSA in absence of radiographic evidence of metastatic prostate cancer is allowed.
- •2 . Concurrent administration of any anti-cancer therapies (e.g. chemotherapy, other targeted therapy, experimental drug, etc) other than those administered in this study and concurrent treatment on another therapeutic clinical trial.
- •3 . Known hypersensitivity to Dabrafenib.
- •5 Pregnant (negative serum pregnancy test is required in women of child-bearing potential) or lactating women.
- •6. Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption. Patients must be able to swallow tablets.
- •7. Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, hypertension not adequately controlled by current medications.
- •8. History of congenital long QT syndrome, presence of clinically significant ventricular or atrial dysrhythmias = Grade 2 (NCI CTCAE Version 4.0).
- •9. Corrected QT (QTc) interval =500 msec at baseline or uncorrectable electrolyte abnormalities.
- •10. Active hepatitis infection or positivity for human immunodeficiency virus.
- •11. Uncontrolled medical illness.
- •12. Other severe, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, which in the judgment of the investigator would make the patient inappropriate for entry into this study.
- •13. Unwillingness to practice effective birth control.
- •14. Inability to comply with other requirements of the protocol.
研究者
相似试验
进行中（未招募）
1 期
STUDY OF THE CLINICAL ACTIVITY AND SAFETY OF VEMURAFENIB (ZELBORAF) IN COMBINATION WITH MONOCLONAL ANTIBODY RITUXIMAB (MABTHERA) IN PREVIOUSLY TREATED PATIENTS WITH HAIRY CELL LEUKEMIA (HCL) CARRYING THE BRAF-V600E MUTATIOEUCTR2014-003046-27-ITDipartimento di Medicina10
进行中（未招募）
不适用
A Study Evaluating RO5479599 in Combination with Carboplatin and Paclitaxel in Patients with Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) of Squamous Histologyon-Small Cell Lung CancerMedDRA version: 18.0Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2014-001498-15-NLF. Hoffmann- La Roche Ltd.17
已完成
不适用
OPEN-LABEL PHASE Ib/II, MULTICENTER STUDY OF THE COMBINATION OF RO5479599 WITH CARBOPLATIN AND PACLITAXEL IN PATIENTS WITH ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) OF SQUAMOUS HISTOLOGY WHO HAVE NOT RECEIVED PRIOR CHEMOTHERAPY OR TARGETED THERAPY FOR NSCLCgevorderde en/of gemetastaseerde sqNSCLCsquamous Non-Small Cell Lung Cancer10038666cancerNL-OMON41018Roche Nederland B.V.5
进行中（未招募）
1 期
A Study Evaluating RO5479599 in Combination with Carboplatin and Paclitaxel in Patients with Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) of Squamous Histologyon-Small Cell Lung CancerMedDRA version: 17.1 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2014-001498-15-GBF. Hoffmann- La Roche Ltd.12
进行中（未招募）
1 期
A Study Evaluating RO5479599 in Combination with Carboplatin and Paclitaxel in Patients with Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) of Squamous HistologyEUCTR2014-001498-15-DKF. Hoffmann- La Roche Ltd.17