NL-OMON55368已完成不适用
A Phase I, open-label, dose escalation study of oral LGK974 in patients malignancies dependent on Wnt ligands - CLGK974X2101
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ovartis
- 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. Diagnosis of locally advanced or metastatic cancer that has progressed
- •despite standard therapy or for which no effective standard therapy exists and
- •histological confirmation of one of the following diseases indicated below:
- •Single agent LGK974- Dose escalation part: documented B-RAF mutant
- •colorectal cancer; or pancreatic adenocarcinoma. In addition, tumors of any
- •histological origin with previously documented genetic alterations upstream in
- •the Wnt signaling pathway, such as gene fusions in RSPOs and mutations in
- •RNF43, are eligible with prior agreement with Novartis
- •Single Agent LGK974 -Dose expansion part: documented B-RAF mutant colorectal
- •cancer with documented RNF43 mutation and/or RSPO fusion of pancreatic
- •adenocarcinoma with documented RNF43 mutation. In addition, patients with
- •tumors of any histological origin with documented genetic alterations upstream
- •in the Wnt signaling pathway, such as gene fusions in RSPOs and mutations in
- •RNF43, are eligible with prior agreement with Novartis• LGK974 with PDR001:
- •Dose escalation: patients with the following cancers that were previously
- •treated with anti-PD-1 therapy and whose best response on that therapy was
- •progressive disease (i.e., primary refractory): melanoma, lung SCC, HNSCC.
- •Patients with esophageal SCC, cervical SCC or TNBC who are either naive or
- •primary refractory to prior anti-PD-1 therapy.
- •LGK974 with PDR001: Dose expansion: patients with pancreatic cancer, or TNBC,
- •or melanoma, or head and neck squamous cell cancer.
- •Patients with cancers of squamous cell histology must have had progression on
- •or after, or intolerance to, a prior platinum-containing chemotherapy regimen-
- •WHO performance status of 0-2
排除标准
- •1.Patients with a primary central nervous system tumor or with uncontrolled,
- •symptomatic brain metastases that have not been adequately treated. Patients
- •with symptomatic brain metastases that have been adequeatly treated, such as
- •with radiotherapy or resection, are not excluded if any associated symptoms are
- •stable, and do not require ongoing glucocorticoid therapy.
- •2: Impaired cardiac function including any one of the following:
- •- Corrected QT interval (QTc) > 480 milliseconds on baseline ECG.
- •- Clinically significant, uncontrolled heart disease (e.g. unstable angina,
- •congestive heart failure, uncontrolled hypertention, ventricular or atrial
- •arrhythmias)
- •- Myocardial infarction (MI) within the prior 3 months.
- •3.Patients with any of the following laboratory values at baseline:
- •- Absolute neutrophil count (ANC) < 1.0 109/L
- •- Platelets < 75 109/L
- •- Hemoglobin < 9.0 g/dL
- •- Calculated or measured creatinine clearance (using Cockcroft-Gault formula) <
- •- Bilirubin > 1.5 x ULN
- •- Aspartate transaminase (AST) and alanine transaminase (ALT) > 3.0 x ULN,
- •except for patients with liver metastasis who are excluded if AST and ALT > 5.0
- •4. Impairment of gastrointestinal function or gastrointestinal disease that may
- •significantly alter the absorption of oral LGK974 (e.g., ulcerative diseases,
- •uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel
- •resection).
- •5. Presence of >CTCAE Grade 2 toxicity (except alopecia) due to prior therapy.
- •6.Malignant disease other than that being treated in this study.
研究者
相似试验
进行中（未招募）
1 期
ATA-200 gene therapy trial in patients with LGMDR5limb-girdle muscular dystrophy type R5 (previously named LGMD2C)MedDRA version: 20.0Level: PTClassification code: 10028356Term: Muscular dystrophy Class: 100000004850CTIS2023-506440-16-00Atamyo Therapeutics6
进行中（未招募）
1 期
Clinical study using the drug GSK525762 in Subjects with cancerT Midline Carcinoma and other solid tumorsMedDRA version: 18.0Level: LLTClassification code 10007284Term: CarcinomaSystem Organ Class: 100000004864EUCTR2014-004982-25-FRGlaxoSmithKline Research and Development Ltd196
进行中（未招募）
1 期
Clinical study using the drug GSK525762 in subjects with hematologic malignanciesPatients with relapsed and/or refractory haematological malignancies (lymphoma, leukemia, or multiple myeloma)MedDRA version: 19.0Level: LLTClassification code 10066481Term: Hematological malignancySystem Organ Class: 100000004864EUCTR2013-000445-39-ESGlaxoSmithKline, S.A.111
进行中（未招募）
1 期
Clinical study using the drug GSK525762 in Subjects with cancerEUCTR2014-004982-25-NLGlaxoSmithKline Research and Development Ltd196
进行中（未招募）
1 期
Clinical study using the drug GSK525762 in Subjects with cancerT Midline Carcinoma and other solid tumors.MedDRA version: 18.0 Level: LLT Classification code 10007284 Term: Carcinoma System Organ Class: 100000004864EUCTR2014-004982-25-ESGlaxoSmithKline, S.A.196