NL-OMON47107已完成不适用
HDAC inhibitor vorinostat in resistant BRAF V600 mutated advanced melanoma - Vorinostat in advanced BRAF V600 melanoma
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 33 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Histological proof of advanced melanoma with BRAF V600 mutation;
- •2. Progression of disease, according to RECIST 1.1 or clinical progression, while on treatment with BRAFi, such as vemurafenib or dabrafenib, or the combination of BRAFi and MEKi such as vemurafenib plus cobimetinib or dabrafenib plus trametinib;
- •3. At least one progressive target lesion according to RECIST 1.1;
- •4. Previous documented response of at least 4 weeks to treatment with the BRAFi and/or BRAFi+MEKi;
- •5. Start with vorinostat treatment within a maximuminimum period of 3 days after discontinuation of BRAFi and/or BRAFi+MEKi. The BRAFi and/or BRAFi+MEKi can be continued after progression to provide sufficient time to perform baseline assessments;
- •6. Age * 18 years;
- •7. Able and willing to give written informed consent;
- •8. WHO performance status of 0, 1 or 2;
- •9. Able and willing to undergo blood sampling for PK and PD analysis;
- •10. Life expectancy * 3 months allowing adequate follow up of toxicity evaluation and antitumor activity;
- •11. Evaluable Measurable disease according to RECIST 1.1;
- •12. Minimal acceptable safety laboratory values
- •a. ANC of * 1.5 x 109 /L
- •b. Platelet count of * 100 x 109 /L
- •c. Hemoglobin * 6.0 mmol/L
- •d. Hepatic function as defined by serum bilirubin * 1.5 x ULN, ALAT and ASAT * 2.5 x ULN, or in case of liver metastases ALAT and ASAT * 5 x ULN
- •e. Renal function as defined by serum creatinine * 1.5 x ULN or creatinine clearance * 50 ml/min (by Cockcroft-Gault formula, or MDRD)
- •13. Negative pregnancy test (urine/serum) within 72 hours before receiving the first dose of study medication for female patients with childbearing potential;
- •14. Able and willing to undergo fresh histological tumor sampling of progressive target lesion prior to start, upon treatment and upon progression of vorinostat if technically possible.
排除标准
- •1. Any treatment with investigational drugs within 28 days prior to receiving the first dose of investigational treatment; or 21 days for standard chemotherapy and immunotherapy;
- •2. Patients who have had previous treatment with vorinostat or other HDACi;
- •3. Leptomeningeal disease;
- •4. Symptomatic brain metastasis. Patients previously treated or untreated for the conditions who are asymptomatic in the absence of corticosteroid therapy are allowed to enroll. Brain metastasis must be stable with verification by imaging (e.g. brain MRI or CT completed at screening demonstrating no current evidence of progressive brain metastases). Patients are not permitted to receive enzyme inducing anti-epileptic drugs or corticosteroids;
- •5. Woman who are pregnant or breast feeding;
- •6. Unreliable contraceptive methods. Both men and women enrolled in this trial must agree to use a reliable contraceptive method throughout the study (adequate contraceptive methods are: condom, sterilization, other barrier contraceptive measures preferably in combination with condoms)
- •7. Radiotherapy within the last 4 weeks prior to receiving the first dose of investigational treatment; except 1x8 Gy for pain palliation;
- •8. Uncontrolled infectious disease or known Human Immunodeficiency Virus HIV-1 or HIV-2 type patients
- •9. Patients with a known history of hepatitis B or C;
- •10. Recent myocardial infarction (< 6 months) or unstable angina
研究者
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