NCT02047344已完成2 期
A Single-Arm, Open-Label, Phase II Trial Evaluating the Efficacy, Safety and Pharmacokinetics of Antroquinonol in Patients With Stage IV (Including Pleural Effusion) Non Squamous NSCLC Who Have Failed Two Lines of Anti-Cancer Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 10
- 主要终点
- Progression Free Survival Rate
研究概览
简要总结
This is a single arm, open label, Phase II study in KRAS-positive and KRAS-negative patients with stage IV (including pleural effusion) non squamous NSCLC who have failed two lines of anti-cancer therapy. A maximum of 60 evaluable patients with NSCLC will receive antroquinonol, of which 30 patients will be KRAS-positive and 30 patients KRAS-negative. An evaluable patient will have received at least one dose of antroquinonol and have a valid baseline tumor assessment. Enrollment will continue until the target number of evaluable patients has been enrolled.
详细描述
- Progression free survival rate at 12 weeks, defined as the proportion of patients alive and progression free at Week 12. Patients will be progression free if they have no tumor assessments of progressive disease (defined according to RECIST guidelines, version 1.1) at any point from the start of treatment to Week 12.
- Objective response rate (ORR), defined as the proportion of patients whose best overall response is either CR or PR according to RECIST version 1.1. The best overall response is the best response recorded during the first 12 week treatment cycle.
- Disease control rate (DCR), defined as the proportion of patients with a documented CR, PR and SD during the first 12 week treatment cycle according to RECIST version 1.1.
- Duration of overall tumor response (DR), defined as the interval between the date of the first observation of tumor response (CR or PR) and the date of disease progression or death.
- Progression free survival defined as the time from randomization to objective tumor progression by RECIST version 1.1 or death due to any cause, whichever occurs first.
- Overall survival (OS) defined as the time from randomization to death from any cause.
- Time to progression (TTP) defined as the time from randomization to objective tumor progression by RECIST version 1.1.
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
- •Cytologically or histologically confirmed non squamous NSCLC Stage IV (including pleural effusion).
- •Radiologically confirmed disease progression following two previous lines of anti-cancer therapy, one of which should be a platinum based regimen, OR the patient has refused treatment with approved treatment modalities
- •At least one radiologically measurable target lesion per RECIST version 1.1
- •Fresh or archival biopsy tissue available to determine tumor mutation status
- •Written informed consent that is consistent with International Conference on Harmonisation Tripartite Guideline on Good Clinical Practice guidelines
- •Patient or legally acceptable representative has granted written informed consent before any study specific procedures (including special Screening tests) are performed
- •Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1 or 2
- •Hemoglobin ≥ 9.0 g/dL; platelets ≥ 100 x 109/L; absolute neutrophil count ≥ 1.5 x 109/L without the use of hematopoietic growth factors
- •Bilirubin and creatinine less than 2 × upper limit of normal (ULN) for the institution
- •Albumin ≥ 2.5 mg/dL
- •Aspartate aminotransferase and alanine aminotransferase less than 5 × ULN for the institution
- •Prothrombin time less than 1.5 × ULN for the institution
- •Potassium, magnesium and phosphorus within the normal range for the institution (supplementation is permissible)
- •Recovery to Grade 1 or baseline of any toxicities due to prior treatments, excluding alopecia
排除标准
- •Chemo-, hormone- or immunotherapy, within 4 weeks or within less than four half lives of the date of first administration of study drug and/or persistence of toxicities of prior anti-cancer therapies which are deemed to be clinically relevant
- •Radiotherapy within the past 2 weeks prior to date of first administration of study drug
- •Previous treatment with an histone deacetylase inhibitor or an epidermal growth factor receptor inhibitor within at least 4 weeks of the date of first administration of study drug
- •Treatment with any drug(s) known to be an inhibitor or inducer of cytochrome P450 (CYP)2C19, CYP3A4, CYP2C8, and CYP2E1, within 14 days of the date of first administration of study drug
- •Brain metastases, which are symptomatic; patients with treated, brain metastases are eligible with stable brain disease for at least 4 weeks without the requirement for steroids or anti epileptic therapy
- •Inability to swallow oral medications or a recent acute gastrointestinal disorder with diarrhea e.g., Cohn's disease, malabsorption, or Common Terminology Criteria for Adverse Event (CTCAE) Grade > 2 diarrhea of any etiology at baseline
- •Other malignancies diagnosed within the past five years (other than curatively treated cervical cancer in situ), non melanoma skin cancer, superficial bladder tumors Ta (non invasive tumor) and TIS (carcinoma in situ)
- •Patients with any serious active infection (i.e., requiring an intravenous antibiotic, antifungal, or antiviral agent)
- •Patients with known human immunodeficiency virus, active hepatitis B or active hepatitis C
- •Patients who have any other life threatening illness or organ system dysfunction, which in the opinion of the investigator, would either compromise patient safety or interfere with the evaluation of the safety of the study drug
- •Known or suspected substance abuse or alcohol abuse
- •Pregnancy or breast feeding
- •History of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina, myocardial infarction, arrhythmia, including New York Heart Association functional classification of three
研究组 & 干预措施
Antroquinonol (Hocena)
Experimental
patients will receive one 12 week cycle of antroquinonol 200 mg t.i.d. or until disease progression, unacceptable toxicity, non compliance or withdrawal of consent by the patient, or the investigator decides to discontinue treatment, whichever comes first.
干预措施: Antroquinonol (Drug)
结局指标
主要结局
Progression Free Survival Rate
时间窗: 12 weeks
Tumor response will be assessed at 6 week intervals during the first treatment cycle using the RECIST criteria, version 1.1. Each patient will be assigned one of the following categories: 1) complete response (CR), 2) partial response (PR), 3) stable disease (SD), or 4) progressive disease (PD). Patients who died from any cause or discontinued the study for any reason without a post screening or Week 12 tumor assessment will be considered as failing to respond to treatment.
次要结局
- Disease Control Rate (DCR)(12 weeks)
- T½: the Time Required for a Quantity to Reduce to Half Its Initial Value(8 hours)
- Cmax(8 hours)
研究者
研究点 (10)
Loading locations...
相似试验
招募中
1 期
Pharmacokinetics and Safety of DolutegravIr in NeonateHivNCT05590325Desmond Tutu TB Centre56
Unknown
2 期
A Phase 2 Clinical Study of YY-20394 in Patients With Relapsed/Refractory Follicular LymphomaFollicular LymphomaNCT04379167Shanghai YingLi Pharmaceutical Co. Ltd.140
进行中（未招募）
2 期
Assessment of the Efficacy and Safety of Pembrolizumab for Ovarian Squamous Cell CarcinomaOvarian Squamous Cell CarcinomaNCT05737199Niigata University Medical & Dental Hospital21
进行中（未招募）
1 期
A Phase II, open-label, single arm study to evaluate the safety, efficacy, and pharmacokinetics of twice daily midostaurin (PKC412) combined with standard chemotherapy and as a single agent post-consolidation therapy in children with untreated FLT3-mutated AMuntreated FLT3-mutated acute myeloid leukemiaMedDRA version: 21.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000004864EUCTR2017-004830-28-DEovartis Pharma AG23
进行中（未招募）
1 期
A Phase II, open-label, single arm study to evaluate the safety, efficacy, and pharmacokinetics of twice daily midostaurin (PKC412) combined with standard chemotherapy and as a single agent post-consolidation therapy in children with untreated FLT3-mutated AMuntreated FLT3-mutated acute myeloid leukemiaMedDRA version: 21.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2017-004830-28-ATovartis Pharma AG23