A double blind randomised phase 2 trial of docetaxel with or without AZD6244 in wt BRAF advanced melanoma - Docetaxel +/- AZD6244 in Melanoma

niversity of Oxford0 个研究点目标入组 80 人开始时间: 2010年7月19日最近更新: 2020年7月13日

适应症

试验速览

暂无简介。

•BRAF Mutation Screening
•In the opinion of the investigator the patient is likely to fulfil the eligibility criteria of the main study
•= 16 years of age, written informed consent
•Histologically confirmed, wild type BRAF, metastatic melanoma.
•Unresectable Stage III or Stage IV metastatic melanoma.
•Measurable disease as defined by modified RECIST criteria.
•Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1.
•Adequate haematological, hepatic and renal function.
•Adequate cardiac function (NYHA 0-1).
•No evidence of brain metastases or treated brain metastasis with no evidence of relapse on cerebral MRI, or stable off treatment for 3 months.
•Life expectancy > 12 weeks.
•LDH = 2xULN.
•Are the trial subjects under 18? yes
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•BRAF Mutation Screening
•In the opinion of the investigator the patient is not likely to fulfil the eligibility criteria of the main study
•Radiotherapy or systemic melanoma therapy within 28 days prior to starting treatment.
•Prior DNA damaging agents or BRAF or MEK inhibitors for metastatic melanoma
•Pregnancy or breastfeeding woman
•Grade = 2 peripheral neuropathy at study entry
•Known severe hypersensitivity to drugs formulated in polysorbate 80
•Ocular or mucosal malignant melanoma
•Another active malignancy within the past five years
•Clinically significant and uncontrolled major medical condition(s).
•Refractory nausea and vomiting, chronic gastrointestinal diseases (eg, inflammatory bowel disease) or significant bowel resection that would preclude adequate absorption of AZD6244.
•Taking medication known to interact significantly with CYP3A4.

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