ACTRN12621001436864终止1 期
A two-part open label Phase 1/2 study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of the combination of cetuximab, cobimetinib and palbociclib in subjects with K-RAS wild-type BRAF V600E mutated, or K-RAS mutated, advanced or metastatic colorectal cancer who have failed all available standard therapies
Cothera Bioscience Pty ltd0 个研究点目标入组 3 人开始时间: 2021年10月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •* Males or females aged 18 years and older.
- •* Signed informed consent.
- •* Histologically or cytologically confirmed advanced or metastatic colorectal cancer that is refactory to all available standard therapies
- •* Tumor expression of BRAF V600E mutation or KRAS mutation
- •* Females postmenopausal or willing to use effective birth control
- •* Males patients must use effective birth control
- •* Females with a negative pregnancy test at Screening
- •* Have stopped previous anticancer therapy for at least 3 weeks or 5 half lives prior to Screening
排除标准
- •* Concomitant anticancer therapy, systemic immune therapy, hormonal therapy, nontraditional and/or herbal therapy as cancer therapy.
- •* Unresolved NCI CTCAE (v5.0) greater than or equal to Grade 2 toxicity from any prior anticancer therapy
- •* Symptomatic brain metastases
- •* History of known spinal cord cell compression or carcinomatous meningitis
- •* Pregnant or actively breastfeeding.
- •* Active hepatitis B or hepatitis C infection
- •* Known history of HIV infection
- •* Documented malignancies other than CRC within 3 years prior
- •* Clinically significant cardiac disease
- •* Signs or symptoms of organ failure, major chronic illnesses other than cancer
- •* Treatment with medications known to be strong CYP3A4 inhibitors within 7 days prior to Day 1 of treatment or CYP3A4 inducers within 14 days prior to Day 1 of treatment.
- •* Previous history of keratitis, ulcerative keratitis or severe form of dry eye
- •* Known pre-existing interstitial lung disease
- •* History of or evidence of retinal pathology
- •* Treatment with another investigational drug, or investigational device within 30 days before dosing
研究者
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