跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/EUCTR2014-002230-32-BE
EUCTR2014-002230-32-BE进行中（未招募）1 期

A MULTISTAGE, PHASE II STUDY EVALUATING THE SAFETY AND EFFICACY OF COBIMETINIB PLUS PACLITAXEL, COBIMETINIB PLUS ATEZOLIZUMAB PLUS PACLITAXEL, OR COBIMETINIB PLUS ATEZOLIZUMAB PLUS NAB-PACLITAXEL AS FIRST-LINE TREATMENT FOR PATIENTS WITH METASTATIC TRIPLE-NEGATIVE BREAST CANCER

F. Hoffman-La Roche Ltd.0 个研究点目标入组 162 人开始时间: 2014年11月25日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
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
162
研究概览入排标准研究者记录与标识符相似试验

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 or1
  • •- Histologically confirmed estrogen receptor (ER) negative, progesterone receptor (PR) negative, and human epidermal growth factor receptor 2 (HER2)-negative adenocarcinoma of the breast, with measurable metastatic or locally advanced disease
  • •- Locally advanced disease must not be amenable to resection with curative intent
  • •- Measurable disease, according to response evaluation criteria in solid tumours (RECIST), v1.1
  • •- 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 gram (g)/decilitre (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 milligram/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/nab-paclitaxel,at least 5 months after the last dose of
  • •atezolizumab, and 3 months after the last dose of cobimetinib.
  • •- 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
  • •- Men must agree not to donate sperm or have intercourse with a female partner
  • •without using appropriate barrier contraception during the treatment period and for 6 months after the last dose of paclitaxel/nab-paclitaxel and 3 months after the last dose of Cobimetinib. Male patients should seek advice on conservation of
  • •sperm prior to treatment because of the possibility of irreversible infertility due to therapy with Abraxane® (paclitaxel protein-bound particles for injectable suspension) (albumin bound) or lower fertility with paclitaxel.
  • •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 patient)
  • •- HER2 positivity is defined as one of the following: immunohistochemistry (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 eligible
  • •- 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 months prior to initiation of study treatment (Cycle [C] 1 Day [D]1)
  • •- Any systemic anti-cancer therapy within 3 weeks[W] prior to C1, D1
  • •- Any radiation treatment to metastatic site within 28 days of C1, D1
  • •- Major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to C1, D1, 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 rapidly accelerated fibrosarcoma (Raf), MEK (MAPK [Mitogen-activated protein kinases]/Erk kinase), or the MAPK pathway
  • •- Previous therapy with Akt, phosphoinositide 3-kinase (PI3K), and/or mechanistic target of rapamycin (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 >= 21 mmHg
  • •-Serum cholesterol >= Grade 2
  • •-Hypertriglyceridemia >= Grade 2
  • •-Hyperglycemia (fasting) >= Grade 2
  • •-Left ventricular ejection fraction (LVEF) below institutional lower limit of normal (LLN) or below 50%, whichever is lower
  • •- Use of strong cytochromes P450 (CYP)3A4/5 inhibitors such as but not limited to atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandamycin, and voriconazole
  • •- Strong CYP3A4/5 inducers such as but not limited to rifampin, carbamazepine, rifapentine, phenytoin, and phenobarbital
  • •- The following foods/supplements are prohibited at least 7 days prior to initiation of and during study treatment:
  • •-St. John's wort or hyperforin (potent CYP3A4 enzyme inducer)
  • •-Grapefruit juice (potent cytochrome P450 CYP3A4 enzyme inhibitor)
  • •- Pregnancy (positive serum pregnancy test) or lactation
  • •- Uncontrol

研究者

发起方
F. Hoffman-La Roche Ltd.

相似试验

进行中（未招募）
1 期
A Multi-Part, Clinical Study Testing The Safety And Effectiveness of Cobimetinib Plus Paclitaxel, Cobimetinib Plus Atezolizumab Plus Paclitaxel, or Cobimetinib Plus Atezolizumab Plus Nab-Paclitaxel As Initial Treatment For Patients With Triple-Negative (HER2 Negative, Estrogen Receptor Negative, and Progesterone Receptor Negative) Breast Cancer That Has Spread.
EUCTR2014-002230-32-LVF. Hoffman-La Roche Ltd.162
进行中（未招募）
1 期
A multi-part, clinical study testing the safety and effectiveness of combination plus with paclitaxel, cobimetinib plus atezolizumab plus paclitaxel, or cobimetinib plus atezolizumab plus nab-paclitaxel as initial treatment for patients with triple-negative (HER2 negative, Estrogen receptor negative, and Progesterone receptor negative) breast cancer that has spread.
EUCTR2014-002230-32-CZF. Hoffman-La Roche Ltd.162
进行中（未招募）
1 期
A multi-part, clinical study testing the safety and effectiveness of cobimetinib in combination with paclitaxel as initial treatment for patients with triple-negative (HER2 negative, Estrogen receptor negative, and Progesterone receptor negative) breast cancer that has spread.Patients with metastatic or locally advanced, triple-negative adenocarcinoma of the breast that have not received prior systemic therapy for metastatic breast cancer.
EUCTR2014-002230-32-FRF. Hoffman-La Roche Ltd.112
进行中（未招募）
1 期
A multi-part, clinical study testing the safety and effectiveness of cobimetinib in combination with paclitaxel as initial treatment for patients with triple-negative (HER2 negative, Estrogen receptor negative, and Progesterone receptor negative) breast cancer that has spread.Patients with metastatic or locally advanced, triple-negative adenocarcinoma of the breast that have not received prior systemic therapy for metastatic breast cancer.
EUCTR2014-002230-32-LTF. Hoffman-La Roche Ltd.162
进行中（未招募）
1 期
A multi-part, clinical study testing the safety and effectiveness of combination plus with paclitaxel, cobimetinib plus atezolizumab plus paclitaxel, or cobimetinib plus atezolizumab plus nab-paclitaxel as initial treatment for patients with triple-negative (HER2 negative, Estrogen receptor negative, and Progesterone receptor negative) breast cancer that has spread.
EUCTR2014-002230-32-GBF. Hoffman-La Roche Ltd.162