NCT03228186终止2 期
Phase II Trial of Pevonedistat (TAK-924) Plus Docetaxel in Patients With Previously Treated Advanced Non-Small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The Percentage of Patients That Respond to Treatment
研究概览
简要总结
This study is a single institution Phase II single arm trial to assess the efficacy of the combination of pevonedistat plus docetaxel in patients with previously treated advanced NSCLC (non-small cell lung cancer).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years of age or older
- •Histologically confirmed stage IV NSCLC (adenocarcinoma, squamous cell carcinoma, large cell carcinoma, or not otherwise specified) or recurrent NSCLC not amenable to curative therapy
- •Patients must have already received platinum-based chemotherapy; they may have also received prior immunotherapy or targeted therapy
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (an attempt to quantify cancer patients' general well-being and activities of daily life. The score ranges from 0 to 5 where 0 is asymptomatic and 5 is death.)
- •Clinical laboratory values within appropriate parameters
- •Female patients who are of childbearing potential and all males must agree to practice true abstinence or use effective methods of contraception
- •Patients must be able to understand and sign the informed consent.
- •Patients must have measurable disease as defined by RECIST v1.1 criteria
- •It is preferable that patients have an adequate tissue sample available
排除标准
- •Treatment with any investigational products within 4 weeks before the first dose of any study drug
- •Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of study procedures
- •Active uncontrolled infection or severe infectious disease, such as severe pneumonia, meningitis, or septicemia that require IV antibiotics within 2 weeks of starting study treatment
- •Major surgery within 14 days before the first dose of any study drug or a scheduled surgery during study period
- •Diagnosed or treated for another malignancy within 2 years before randomization or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone resection.
- •Life-threatening illness unrelated to cancer
- •Patients with uncontrolled coagulopathy or bleeding disorder
- •Known human immunodeficiency virus (HIV) seropositivity
- •Known hepatitis B surface antigen seropositivity or known or suspected active hepatitis C infection
- •Known hepatic cirrhosis or severe pre-existing hepatic impairment
- •Known cardiopulmonary disease
- •Uncontrolled high blood pressure (ie, systolic blood pressure > 180 mm Hg, diastolic blood pressure > 95 mm Hg)
- •Prolonged rate corrected QT (QTc) interval ≥ 500 msec, calculated according to institutional guidelines
- •Interstitial lung disease or pulmonary fibrosis
- •Systemic antineoplastic therapy or radiotherapy for other malignant conditions within 14 days before the first dose of any study drug, except for hydroxyurea.
- •Symptomatic or history of untreated brain or leptomeningeal metastases. Treated patients should be neurologically stable for 4 weeks after completion of appropriate therapy. Patients should be off steroids at least 3 days prior to start of therapy on clinical trial.
- •Treatment with clinically significant metabolic enzyme inducers within 14 days before the first dose of the study drug. Clinically significant metabolic enzyme inducers are not permitted during this study (see Appendix III for more details).
- •Female patients who are lactating, breastfeeding, or have a positive pregnancy test
- •Female patients who intend to donate eggs (ova) during the course of this study or 4 months after receiving their last dose of study drug(s).
- •Male patients who intend to donate sperm during the course of this study or 4 months after receiving their last dose of study drug(s).
- •Known hypersensitivity to docetaxel or other drugs formulated with polysorbate 80
- •Prior therapy with docetaxel for non-small cell lung cancer
- •Peripheral neuropathy of CTCAE v4.03 grade ≥ 2
研究组 & 干预措施
Pevonedistat plus Docetaxel
Experimental
Pevonedistat 25mg/m2 days 1, 3, 5 Docetaxel 75mg/m2 day 1 21 day cycle
干预措施: Pevonedistat (Drug)
Pevonedistat plus Docetaxel
Experimental
Pevonedistat 25mg/m2 days 1, 3, 5 Docetaxel 75mg/m2 day 1 21 day cycle
干预措施: Docetaxel (Drug)
结局指标
主要结局
The Percentage of Patients That Respond to Treatment
时间窗: Up to 2 Years
Response is defined as either Partial Response or Complete Response. Partial Response is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. There can be no appearance of new lesions. Complete Response is defined as the disappearance of all target lesions, determined by two separate observations conducted not less than 4 weeks apart. There can be no appearance of new lesions.
次要结局
- Median Progression Free Survival Time(Up to 2 Years)
- Median Overall Survival Time(Up to 2 Years)
- The Number of Patients Who Achieve Stable Disease(Up to 2 Years)
- The Number of Toxicities by System Organ Class(up to 30 days post last study drug dose, patients were allowed to stay on study drug treatment until progression. Data was collected over 3.5 years.)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Pevonedistat and Decitabine in Treating Patients With High Risk Acute Myeloid LeukemiaRecurrent Acute Myeloid LeukemiaRefractory Acute Myeloid LeukemiaSecondary Acute Myeloid LeukemiaTherapy-Related Acute Myeloid LeukemiaUntreated Adult Acute Myeloid LeukemiaAcute Myeloid LeukemiaNCT03009240City of Hope Medical Center12
终止
2 期
Pevonedistat and Azacitidine as Maintenance Therapy After Allogeneic Stem Cell Transplantation for Non-Remission AMLAcute Myeloid Leukemia (AML)NCT03709576Milton S. Hershey Medical Center3
进行中（未招募）
1 期
Pevonedistat and Ibrutinib in Treating Participants With Relapsed or Refractory CLL or Non-Hodgkin LymphomaB-Cell Prolymphocytic LeukemiaRecurrent Chronic Lymphocytic LeukemiaRecurrent Diffuse Large B-Cell LymphomaRecurrent Follicular LymphomaRecurrent Lymphoplasmacytic LymphomaRecurrent Mantle Cell LymphomaRecurrent Marginal Zone LymphomaRecurrent Non-Hodgkin LymphomaRecurrent Small Lymphocytic LymphomaRefractory Chronic Lymphocytic LeukemiaRefractory Diffuse Large B-Cell LymphomaRefractory Follicular LymphomaRefractory Lymphoplasmacytic LymphomaRefractory Mantle Cell LymphomaRefractory Marginal Zone LymphomaRefractory Non-Hodgkin LymphomaRefractory Small Lymphocytic LymphomaRichter SyndromeNCT03479268City of Hope Medical Center18
终止
1 期
Pevonedistat and Pembrolizumab for the Treatment of dMMR/MSI-H Metastatic or Locally Advanced Unresectable Solid TumorLocally Advanced Malignant Solid NeoplasmMetastatic Malignant Solid NeoplasmUnresectable Malignant Solid NeoplasmNCT04800627M.D. Anderson Cancer Center2
招募中
1 期
Disitamab Vedotin Plus Trastuzumab in Patients With HER2 Positive GC/GEJ PatiensHER2-positive Gastric CancerHER2-positive Gastroesophageal Junction AdenocarcinomaNCT06572319Zhejiang Cancer Hospital35