EUCTR2015-005840-33-NL进行中（未招募）1 期
HDAC inhibitor vorinostat in resistant BRAF V600 mutated advanced melanoma
etherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI-AVL)0 个研究点开始时间: 2016年4月13日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •1. Histological proof of advanced melanoma with BRAF V600 mutation;
- •2. Progression of disease 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. Previous documented response (partial or complete) to treatment with the BRAFi and/or BRAFi+MEKi confirmed with an interval of four weeks or more;
- •4. Start with vorinostat treatment within 1 week after discontinuation of BRAFi and/or BRAFi+MEKi. The BRAFi and/or BRAFi+MEKi can be continued untill seven days before start of the treatment with vorinostat;
- •5. Age ? 18 years;
- •6. Able and willing to give written informed consent;
- •7. WHO performance status of 0, 1 or 2;
- •8. Treatment with coumarine-derivates is allowed. However, if possible switch to low molecular weight heparins (LMWH). If switching to a LMWH is not desirable, careful monitoring is recommended with a minimal control of INR once a week;
- •9. Able and willing to undergo blood sampling for pharmacokinetic and pharmacodynamic analysis;
- •10. Life expectancy ? 3 months allowing adequate follow up of toxicity evaluation and antitumor activity;
- •11. Evaluable 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. 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
- •d. 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) for female patients with childbearing potential;
- •14. Able and willing to undergo fresh histological tumor sampling prior to start, upon treatment and upon progression of vorinostat.
- •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 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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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