NL-OMON52356招募中2 期
Open Label Phase 2 Study Neo-Adjuvant BRAF/MEK Inhibition Followed by Surgery and Adjuvant BRAF/MEK Inhibition in In-transit Melanoma Metastases (NASAM) - NASAM
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 28
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. Age over 18 years old
- •2. World Health Organization (WHO) Performance Status 0 or I
- •3. Primary cutaneous melanoma or unknown primary melanoma with pathologically
- •confirmed in-transit metastatic melanoma
- •4. Histologically confirmed presence of BRAFV600E/K mutation in primary tumor
- •5. Patients must have undergone complete disease staging including: PET-CT scan
- •and MRI scan
- •6. Patients must be medically fit to undergo surgery
- •7. Patients must be able to take oral medication
- •8 No prior anticancer systemic treatment (including chemotherapy,
- •immunotherapy, oncolytic viral therapy, other systemic therapies)
- •9. No prior radiotherapy to site of interest (surgical therapy is allowed; in
- •order to obtain pathological information of the melanoma)
- •10. Screening laboratory values must meet the following criteria: WBC >=
- •2.0x109/L, Neutrophils >= 1.0x109/L, Platelets >= 100 x109/L, Hemoglobin >= 6.5
- •mmol/L, AST <= 2.5 x ULN, ALT <= 2.5 x ULN, Total bilirubin <= 1.5 X ULN, INR and
- •PTT in normal range, LDH < 2xULN. Serum creatinine <= 1.5 × ULN; or
- •calculated creatinine clearance >= 50 mL/min by Cockcroft-Gault formula; or
- •estimated glomerular filtration rate > 50 mL/min/1.73m2.
- •11. Absence of additional severe and/or uncontrolled concurrent disease
- •12. Patients known to be human immunodeficiency virus (HIV) positive are
- •eligible if they have undetectable HIV viral load and stable and adequate CD4
- •counts (>= 500 mm^3) on screening labs provided they meet all other protocol
- •criteria for participation and that there are no high-risk drug interactions
排除标准
- •1. Presence of regional lymph node metastases
- •2. Presence of distant metastases
- •3. Current treatment with antiretroviral drugs, herbal remedies and drugs that
- •are strong inhibitors or inducers of CYP3A and CYP2C8
- •4. Patients with active bacterial infections with systemic manifestations
- •(malaise, fever, leukocytosis) are not eligible until completion of appropriate
- •5. Underlying medical conditions that, in the Investigator's opinion, will make
- •the administration of study treatment hazardous or obscure the interpretation
- •of toxicity determination or adverse events
- •6. History of congestive heart failure, active cardiac conditions, including
- •unstable coronary syndromes (unstable or severe angina, recent myocardial
- •infarction), significant arrhythmias and severe valvular disease must be
- •evaluated for risks of undergoing general anesthesia. Furthermore, enlarged QTc
- •interval, uncontrolled hypertension, poor left ventricular function (< 50%,
- •as determined by MUGA scan) and recent thromboembolic or cerebral event.
- •7. History of central serous retinopathy or retinal vein occlusion
- •8. Active intestinal disease interfering with oral drug absorption
- •9. Patients who are unable to be temporally removed from chronic
- •anti-coagulation therapy
- •10. Other malignancy within 2 years prior to entry into the study, except for
- •treated non-melanoma skin cancer and in situ cervical carcinoma
- •11. Patient must not have active hepatitis B, and/or active hepatitis C
- •infection given concerns for drug interactions or increased toxicities. Testing
- •is not required
- •12. Patient must not have any known history of acute or chronic pancreatitis
- •13. Patient must not have any concurrent neuromuscular disorder that is
- •associated with elevated creatine kinase (CK) (e.g., inflammatory myopathies,
- •muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy
- •14. Pregnancy or nursing
研究者
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