EUCTR2016-001860-12-IT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. Written informed consent must be obtained prior to any screening procedures
- •2. Age = 18 years
- •3. ECOG performance status 0 to 2
- •4. Patients have progressed after standard therapy or are intolerant of standard therapy and for whom no standard therapy exists.
- •5. Measurable disease according to RECIST v1.1 for patients with solid tumors or Cheson criteria for patients with NHL (Cheson et al 2014).
- •6. Tumor biopsy is mandatory at study entry. Patients must have a site of disease amenable for biopsy and be a candidate for tumor biopsy. On-Treatment biopsy is required for patients with solid tumors, unless determined by the Investigator as not clinically feasible.
- •7. Histologically or cytologically confirmed diagnosis is required for all indications
- •8. For patients with DLBCL and FL:
- •- In Phase II, patients are required to have documentation of EZH2 mutational status.
- •9. 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).
- •10. For patients with NPC:
- •- Patients must have documentation of presence of p16/CDKN2A gene (at least one copy of p16/CDKN2A gene)
- •11. For patients with ovarian cancer:
- •- Patients must have primary tumor with great than 50% clear cell histomorphology.
- •12. 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).
- •13. 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. Exceptions to this exclusion include the following: malignancies that were treated curatively and have not recurred within 3 years prior to study entry; completely resected basal cell and squamous cell skin cancers; completely resected carcinoma in situ of any type.
- •2. Symptomatic CNS involvement which are neurologically unstable or require increasing doses of steroids to control.
- •3. Impaired cardiac function or clinically significant cardiac disease.
- •4. Current active infection (e.g. viral, bacterial or fungal) requiring systemic therapy.
- •5. 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.
- •6. B-cell lymphoma patients who have received prior allogeneic stem cell transplant
- •7. Inability to take oral medication, or malabsorption syndrome or any other uncontrolled gastrointestinal conditions (e.g. atrophic gastritis, peptic ulcer) that might impair the bioavailability of MAK683.
- •8. Patients with refractory/uncontrolled ascites or pleural effusion.
- •9. Major surgical procedure within 28 days prior to study treatment.
- •10. Patients who have received anti-cancer therapies within the following time frames prior to
- •the first dose of study treatment:
- •¿ B cell lymphoma patients who received autologous stem cell transplantation within 12
- •weeks prior to study drug
- •¿ Castration-Resistant prostate cancer patients who had received radiopharmaceutical agents or immunotherapy (e.g. sipuleucel-T) within 12 weeks prior to study drug
- •¿ The last dose of conventional cytotoxic chemotherapy: = 4 weeks (= 6 weeks for nitrosoureas and mitomycin-C)
- •¿ Biologic therapy (e.g., antibodies, CAR-T): = 4 weeks
- •¿ Non-cytotoxic small molecule therapeutics : = 5 half-lives
- •11. Any unresolved toxicity NCI CTCAE Grade = 2 from previous anticancer therapy with the exception of alopecia and vitiligo
- •12. Insufficient bone marrow function at screening:
- •a) Platelets = 50 x 109/L (50,000/mm3)
- •b) Hemoglobin (Hgb) = 80 g/L (8 g/dL)
- •c) Absolute neutrophil count (ANC) = 1.0 x 109/L (1000/mm3)
- •13. Insufficient hepatic and renal function at screening:
- •a) Alkaline phosphatase (in the absence of bone disease), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) more than or equal to 3 x ULN (more than or equal to 5 x ULN if subject has liver metastases)
- •b) Total bilirubin > 1.5 x ULN.
- •c) Serum creatinine > 1.5 x ULN and/or creatinine clearance = 50 mL/min (calculated
- •using Cockcroft-Gault formula
- •14. Concomitant use of the drugs/remedies that may cause pharmacokinetic drug-drug interactions.
- •15. Chronic steroid therapy other than following: Daily use 10 mg prednisone (or equivalent)
- •or lower dose steroid for control of nausea, vomiting, active autoimmune disease, and
- •seasonal allergies, or to prevent adrenocortical insufficiency. NOTE: topical steroid, or inhaled steroid use is permitted.
- •16. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
- •17. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 4 weeks after discontinuation of treatment.
- •18. Sexually active males unless they use a condom d
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