EUCTR2016-001860-12-DE进行中（未招募）1 期
A phase I/II, multicenter, open-label study of MAK683 in adult patients with advanced malignancies
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 170
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.Patients Age = 18 years
- •2.ECOG performance status 0 to 2
- •3.Patients have progressed after standard therapy or are intolerant of standard therapy and for whom no standard therapy exists.
- •4. Measurable disease according to RECIST v1.1 for patients with solid tumors or Cheson criteria for patients with NHL (Cheson et al 2014).
- •5. Tumor biopsy is mandatory at study entry. Patients must have a site of disease amenable for biopsy and be a candidate for umor biopsy. On-Treatment biopsy is required for patients with solid tumors, unless determined by the Investigator as not
- •clinically feasible.
- •6. Histologically or cytologically confirmed diagnosis is required for all indications
- •- For patients with DLBCL and FL: In Phase II, patients are required to have documentation of EZH2 mutational status.
- •Patients with relapsed or refractory indolent lymphomas, such as FL, must have signs or symptoms indicating the necessity of therapy such as described in practice guidelines ( e.g. Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria, The British National Lymphoma Investigation (BNLI), Italian Society of Hematology (SIE) guideline, or others
- •local practice guidelines).
- •7. For patients with NPC: Patients must have documentation of presence of p16/CDKN2A gene (at least one copy of p16/CDKN2A gene)
- •8. For patients with ovarian cancer: Patients must have primary tumor with great than 50% clear cell histomorphology.
- •9. For patients with prostate cancer: Patients must have evidence of castration resistance as evidenced by a confirmed rising PSA (per Prostate Cancer Working Group 2 [PCWG2] criteria) and a castrate^serum testosterone level (i.e. = 50 ng/dL).
- •10. For patients with sarcoma: Enrollment is limited to epithelioid sarcoma, other types of sarcoma with SWI/SNF alterations may be considered with approval from Novartis.
- •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 110
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1.Other malignant disease than the one being treated in this study
- •2.Severe and/or uncontrolled medical conditions that in the investigator’s opinion could affect the safety of individual or impair the assessment of study result.
- •3.B-cell lymphoma patients who have received prior allogeneic stem cell transplant
- •4.Patient have received anti-cancer therapies within defined time frames prior to the first dose of study treatment
- •5.Symptomatic CNS involvement which are neurologically unstable or requiring increasing doses of steroids to control.
- •6.Patient having out of range laboratory values defined as:
- •1)Insufficient bone marrow function at screening:
- •Platelets = 50 x 109/L (50,000/mm3)
- •Hemoglobin (Hgb) = 90 g/L (9 g/dL)
- •Absolute neutrophil count (ANC) = 1.0 x 109/L (1000/mm3)
- •2)Insufficient hepatic and renal function at screening:
- •ALP, ALT, and AST > 3 x ULN (>5 x ULN if subject has liver metastases)
- •Total bilirubin =2 x ULN
- •Serum creatinine > 1.5 x ULN and/or creatinine clearance = 50 mL/min
- •7.Unable to stop any prohibited medications, including strong CYP3A4 inhibitors or inducers, CYP3A4 or CYP2C8 substrates with a narrow therapeutic index, long acting proton pump inhibitors.
- •Other protocol-defined exclusion criteria may apply.
研究者
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