EUCTR2014-002230-32-IT进行中（未招募）1 期
A MULTISTAGE, PHASE II, STUDY EVALUATING THE SAFETY AND EFFICACY OF COBIMETINIB IN COMBINATION WITH PACLITAXEL AS FIRST-LINETREATMENT FOR PATIENTS WITH METASTATIC TRIPLE-NEGATIVE BREAST CANCER - NA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 162
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
- •Women and men, age = 18 years
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Histologically confirmed ER negative, PR negative, and HER2-negative adenocarcinoma of the breast, with measurable metastatic or locally
- •advanced disease
- •The determination of TNBC status should, whenever possible, utilize tissue from a metastatic or recurrent lesion and where more than one
- •biopsy source is available, priority should be given to the most recent sample.
- •Patients who have not had HER2, ER, or PR testing, and thus, the HER2, ER, and PR status of the breast adenocarcinoma is unknown, are
- •not eligible.
- •Locally advanced disease must not be amenable to resection with curative intent.
- •Measurable disease, according to RECIST, v1.1 (see Appendix 4)
- •Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to first dose of study
- •drug treatment:
- •–Absolute neutrophil count (ANC) = 1.5 × 10 exp9/L
- •–Platelet count = 100 × 10 exp9/L
- •–Hemoglobin = 9 g/dL
- •–Albumin = 2.5 g/dL
- •–Bilirubin = 1.5 × the upper limit of normal (ULN)
- •–Aspartate transaminase (AST), alanine transaminase (ALT), and alkaline phosphatase = 3 × ULN, with the following exceptions:
- •-Patients with documented liver metastases: AST and/or ALT = 5 × ULN
- •-Patients with documented liver or bone metastases: alkaline phosphatase = 5 × ULN
- •–Serum creatinine = 1.5 × ULN or creatinine clearance (CrCl) = 40
- •mL/min on the basis of measured CrCl from a 24-hour urine collection or Cockroft-Gault glomerular filtration rate estimation:
- •[(140-age) x (weight in kg) x (0.85 if female)]/[72 x (serum creatinine in mg/dL)]
- •Ability and capacity to comply with the study and follow-up procedure
- •For female patients (and female partners of male patients) who are not postmenopausal (= 12 months of non-therapy-induced amenorrhea) or
- •surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined contraceptive methods that
- •result in a failure rate of < 1% per year during the treatment period and for at least 6 months after the last dose of paclitaxel and 3 months after
- •the last dose of cobimetinib.
- •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 137
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •Known HER2 positive, ER positive, or PR positive breast cancer by local laboratory assessment (if more than one test result is available and not
- •all results meet the inclusion criterion definition, all results should be discussed with the Medical Monitor to establish eligibility of the patient).
- •HER2 positivity is defined as one of the following: IHC 3 positive or in situ hybridization (ISH) positive
- •ER and PR positivity is defined positive for ER or PR if a finding of =1% of tumor cell nuclei are immunoreactive
- •Patients who have not had HER2, ER, or PR testing, and thus, the HER2, ER, and PR status of the breast adenocarcinoma is unknown, are not
- •Any prior chemotherapy, hormonal, or targeted therapy, for inoperable locally advanced or mTNBC
- •Prior chemotherapy (including taxanes) and/or radiation in the neoadjuvant or adjuvant setting is allowable if treatment occurred = 6 mos prior to initiation of study treatment (Cycle 1 Day1)
- •Any systemic anti-cancer therapy within 3 weeks prior to Cycle 1, Day 1
- •Any radiation treatment to metastatic site within 28 days of Cycle 1, Day 1
- •Major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to Cycle 1, Day 1, or anticipation of need for major
- •surgical procedure during the course of the study
- •Prior therapy with bevacizumab, sorafenib, sunitinib, or other putative vascular endothelial growth factor pathway-targeted therapy within 2
- •years of start of study treatment
- •Prior exposure to experimental treatment targeting Raf, MEK, or the MAPK pathway
- •Previous therapy with Akt, PI3K, and/or mTOR inhibitors
- •Prior therapy with trastuzumab
- •Grade = 2 peripheral neuropathy
- •Brain metastases (symptomatic or non-symptomatic) that have not been treated previously, are progressive, or require any type of therapy
- •(e.g. radiation,surgery or steroids) to control symptoms from brain metastases within 30 days prior to first study treatment dose
- •History of or evidence of retinal pathology on ophthalmologic examination that is considered a risk factor for neurosensory retinal
- •detachment / central serous chorioretinopathy (CSCR), retinal vein occlusion (RVO), or neovascular macular degeneration
- •Patients will be excluded if they currently have the following risk factors for RVO:
- •-Uncontrolled glaucoma with intra-ocular pressures = 21mmHg
- •-Serum cholesterol = Grade 2
- •-Hypertriglyceridemia = Grade 2
- •-Hyperglycemia (fasting) = Grade 2
- •Cobimetinib is metabolized by the hepatic cytochrome CYP3A4 enzyme. The drugs listed below should be avoided. If use of one of these drugs is
- •necessary, the risks and benefits and potential alternatives should be discussed with the Medical Monitor prior to its concomitant use with
- •cobimetinib.
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