ISRCTN43327231已完成2 期
A randomised phase II study of paclitaxel with or without GSK1120212 in advanced wild type BRAF melanoma
niversity of Oxford (UK)0 个研究点目标入组 111 人开始时间: 2012年4月27日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 111
研究概览
简要总结
- 2015 results for dose escalation phase in https://www.ncbi.nlm.nih.gov/pubmed/25542057 2. 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30428063 3. 2020 results in https://www.ncbi.nlm.nih.gov/pubmed/31987431 (added 29/01/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged = 18 years
- •2. Able to provide evidence from an accredited laboratory of wt BRAF status for their melanoma, or ascertainment of wild type BRAF status from a sample of melanoma provided for mutational analysis in Oxford (phase 2 part only).
- •3. Unresectable stage 3 or 4, histologically proven cutaneous or unknown primary melanoma
- •4. Measurable disease as defined by RECIST 1.1 (phase 2 part only)
- •5. ECOG performance score of 0 or 1
- •6. Life expectancy of at least 12 weeks.
- •7. Maximum 2 prior lines of treatment for advanced disease.
- •8. Adequate cardiac function (NYHA 0-1), and LVEF within normal limits on echocardiogram.
- •9. The patient is willing to give consent to the main study and able to comply with the protocol for the duration of the study, including scheduled follow-up visits and examinations.
- •10. Adequate haematological, hepatic and renal function
- •11. Target Gender: Male & Female
- •12. Lower Age Limit 18 years
排除标准
- •1. Any systemic anti-cancer therapy (including participation in other clinical trials) within 28 days prior to Day 1.
- •2. Any radiotherapy within 14 days prior to Day 1.
- •3. Prior taxane or BRAF or MEK inhibitors for metastatic melanoma.
- •4. Any unresolved toxicity from prior anti-cancer therapy that is greater than CTCAE grade 2.
- •5. Pregnancy or breastfeeding women. Female patients must have a negative urinary or serum pregnancy test or have evidence of post-menopausal status (defined as absence of menstruation for > 12 months, bilateral oophrectomy or hysterectomy).
- •6. Grade =2 peripheral neuropathy at study entry.
- •7. Patients of reproductive potential who are not willing to use adequate contraceptive measures for the duration of the study (both male and female patients)
- •8. Known severe hypersensitivity reactions to paclitaxel or other drugs formulated in Cremophor EL and ethanol
- •9. Ocular or mucosal malignant melanoma
- •10. Another active malignancy within the past three years.
- •11. Evidence of brain metastases, unless surgically resected/stereotactic radiosurgery treated brain metastasis with no evidence of relapse on cerebral MRI, or treated brain metastasis and stable off treatment, including steroids, for 3 months.
- •12. Clinically significant and uncontrolled major medical condition(s): such as active infection, bleeding diathesis.
- •13. Patients who are known to be serologically positive for Hepatitis B, Hepatitis C or HIV.
- •14. Inability to swallow tablets, refractory nausea and vomiting, chronic gastrointestinal diseases (eg, inflammatory bowel disease) or significant bowel resection that would preclude adequate absorption.
- •15. Ocular disease predisposing to central serous retinopathy and/or retinal vein occlusion, including increased intraocular pressure, glaucoma, uncontrolled hypertension or uncontrolled diabetes.
研究者
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