EUCTR2014-004685-25-ES进行中（未招募）1 期
A PHASE I/II, MULTICENTER, OPEN-LABEL, DOSE-ESCALATION STUDY OF THE SAFETY AND PHARMACOKINETICS OFCOBIMETINIB IN PEDIATRIC AND YOUNG ADULT PATIENTS WITH PREVIOUSLY TREATED SOLID TUMORS
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 56
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
- •- Signed informed consent form or child's informed assent, when appropriate as determined by patient's age and individual site and country standards
- •- Age >=6 years to <18 years (dose-escalation stage) and >=6 years to <30 years (expansion stage)
- •- Able to comply with the study protocol, in the investigator?s judgment
- •- Tumor for which prior treatment has proven to be ineffective (i.e., relapsed or refractory) or intolerable or for which no standard therapy exists.
- •-Tumor with known or expected RAS/RAF/MEK/ERK pathway involvement. Diagnosis MUST be one of the following tumor types:
- •-Central nervous system gliomas, including high- and low-grade gliomas, and diffuse intrinsic pontine glioma (DIPG)
- •-Embryonal rhabdomyosarcoma and other non-rhabdomyosarcoma soft tissue sarcomas
- •-Neuroblastoma
- •-Malignant peripheral nerve sheath tumor
- •-Tumors from the following groups that in the judgment of the investigator are life threatening, resulting in severe symptoms, or are in close proximity to vital structures:
- •-NF1-associated tumors (including plexiform neurofibroma)
- •-Schwannoma
- •-Any solid tumor or brain tumor that occurs in a patient with a RASopathy (such as NF1 or Noonan syndrome)
- •-Rhabdoid tumors, including atypical teratoid/rhabdoid tumor
- •Any solid or brain tumor that has been molecularly profiled and shown to have RAS/RAF/MEK/ERK pathway activation, with approval of the Medical Monitor.
- •- Tumor diagnosis must be histologically or cytologically confirmed either at the time of diagnosis or at the time of relapse, except in the following scenario:
- •-DIPG does not require histologic confirmation if radiographic findings are sufficient to make diagnosis and institutional standard of care does not mandate biopsy for diagnosis.
- •- Current disease state for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life
- •- Disease that is measurable as defined by International Neuroblastoma Response Criteria (INRC), Response Assessment in Neuro-Oncology (RANO) criteria or Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or evaluable by nuclear medicine techniques, immunocytochemistry techniques, tumor markers, or other reliable measures
- •- Availability of tumor tissue at study enrollment is mandatory. Archival tumor tissue block or 15 freshly cut unstained, serial slides available for submission, and/or willingness to undergo a core or excisional biopsy prior to enrollment
- •- Lansky Performance Status or Karnofsky Performance Status >=50%
- •- Life expectancy >=3 months, in the investigator's judgment
- •- Adequate hematologic and end organ function, defined by the following laboratory results obtained within 28 days prior to initiation of study drug:
- •-Absolute neutrophil count (ANC) >= 0.75 × 10 exp9/L (unsupported)
- •-Platelet count >=75 × 10 exp9/L (unsupported)
- •-Hemoglobin >=8 gram/deciliter (g/dL) (transfusion is acceptable to meet this criterion)
- •-Bilirubin <=1.5 × upper limit of normal (ULN) for age
- •-Aspartate aminotransferase (AST) and alanine transaminase (ALT) <=2.5 × ULN for age
- •-Serum creatinine <=1.5 × ULN for age or creatinine clearance (or radioisotope glomerular filtration rate) > 70 milliliter per minute (mL/min) /1.73 meter exp2/m
- •- Fractional shortening (FS) >= 30% and left ventricular ejection fraction (LVEF) >= 50% at baseline, as determined by echocardiography within 28 days prior to initiation of study drug
- •- Female patients of childbearing potential and
排除标准
- •- Treatment with high-dose chemotherapy and stem-cell rescue (autologous stem cell transplant) within 3 months prior to initiation of study drug
- •- Treatment with thoracic or mediastinal radiotherapy within 6 weeks prior to initiation of study drug
- •- Treatment with hormonal therapy (except hormone replacement therapy or oral contraceptives), immunotherapy, biologic therapy, or herbal cancer therapy within 4 weeks or < 5 half-lives, whichever is shorter, prior to initiation of study drug
- •- Treatment with a long-acting hematopoietic growth factor within 2 weeks prior to initiation of study drug or a short-acting hematopoietic growth factor within 1 week prior to initiation of study drug
- •- Treatment with investigational therapy (with the exception of cancer therapies as described above) within 4 weeks prior to initiation of study drug
- •- Requirement for initiation of corticosteroids or an increase in the dose of corticosteroids within 1 week prior to initiation of study drug
- •- Treatment with St. John's wort or hyperforin or drugs that are strong inhibitors or inducers of CYP within 1 week prior to initiation of study drug
- •- Ingestion of grapefruit juice within 1 week prior to initiation of study drug
- •- Any toxicity (excluding alopecia) from prior treatment that has not resolved to Grade <= 1 (per National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 4.0) at screening except as permitted in the exclusion criteria
- •- Major surgical procedure or significant traumatic injury within 4 weeks prior to initiation of study drug, or anticipation of need for major surgical procedure during the course of the study. Placement of a vascular access device or minor surgery is permitted if the site has healed prior to initiation of study drug
- •- Known active infection (excluding fungal infection of the nail beds) within 28 days prior to initiation of study drug that has not completely resolved
- •- History or evidence of retinal pathology on ophthalmologic examination that is considered to be a risk factor for or indicative of neurosensory retinal detachment, Central Serous Chorioretinopathy (CSCR), neovascular retinopathy, or retinopathy of prematurity
- •- Known hypersensitivity to any component of the study drug
- •- Inability to swallow tablets
- •- Impaired gastrointestinal absorption
- •- Prior allogenic bone marrow transplantation or prior solid organ transplantation
- •- 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
- •- Current drug or alcohol use or dependence that would interfere with adherence to study requirements, in the opinion of the investigator
研究者
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