EUCTR2014-004281-25-GB进行中（未招募）1 期
A Phase 1b/Adaptive Phase 2 Study of Docetaxel With or Without MLN1117 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 155
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
- •Has a histologically and/or cytologically confirmed diagnosis of NSCLC (squamous or nonsquamous).
- •For Phase 2, has a diagnosis of mixed squamous and nonsquamous (or adenosquamous) NSLC.
- •Has locally advanced or metastatic disease (Stage IIIb or Stage IV) with radiographically or clinically evaluable lesions.
- •Has experienced failure of at least 1 prior chemotherapy regimen.
- •For Phase 2, has received 1 prior platinum-based chemotherapy regimen (excluding a docetaxel-containing regimen) for advanced or metastatic (Stage IIIb or Stage IV) disease followed by documented progressive disease.
- •For Phase 1b, has experienced failure of multiple lines of prior chemotherapy.
- •For Phase 2, has archived or fresh tumor biopsy samples obtained during screening sufficient for genotyping.
- •Has adequate organ function, before the first dose of study drug.
- •Has Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- •Female participants who are postmenopausal for at least 1 year before the screening visit or are surgically sterile, or are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 30 days after the last dose of study drug, or agree to practice true abstinence.
- •Male participants agree to practice effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, or agree to practice true abstinence.
- •Has suitable venous access for the study-required blood sampling.
- •Has recovered (ie, <= Grade 1 toxicity or eligibility per this protocol is met) from the reversible effects of prior anticancer therapy.
- •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 130
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •Previous treatment with a PI3K or AKT inhibitor.
- •Prior cancer therapy or other investigational therapy within 2 weeks before the first administration of study drug or failed to recover from the reversible effects of prior anticancer therapies. For prior therapies with a half-life longer than 3 days, the interval must be at least 28 days before the first administration of study drug, and the patient must have documented progressive disease.
- •Has poorly controlled diabetes mellitus defined as HbA1c > 6.5%.
- •Has taken strong inhibitors or strong inducers of CYP3A4 within 14 days before the first dose of study drug.
- •Has taken histamine-H2 receptor antagonists and/or neutralizing antacids within 24 hours before the first administration of study drug.
- •Has taken proton pump inhibitors within 7 days before the first administration of study drug.
- •Has any clinically significant co-morbidities.
- •Has acute myocardial infarction within 6 months before starting study drug, current or history of New York Heart Association Class III or IV heart failure, Evidence of current uncontrolled cardiovascular conditions including cardiac arrhythmias, angina, pulmonary hypertension, or ECG evidence of acute ischemia or active conduction system abnormalities, Fridericia's corrected QT interval > 475 milliseconds (msec) (males) or > 450 msec (females) on a 12-lead ECG during the Screening period, or abnormalities on 12-lead ECG including, but not limited to, changes in rhythm and intervals that in the opinion of the investigator are considered to be clinically significant.
- •Has known, previously diagnosed human immunodeficiency virus infection or active chronic hepatitis B or C.
- •Has brain metastasis, except for those patients who have completed definitive therapy, are not on steroids, have a stable neurologic status for at least 2 weeks after completion of the definitive therapy and steroids, and do not have neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- •Has active secondary malignancy that requires treatment.
- •Has any serious medical or psychiatric illness, including drug or alcohol abuse.
- •Male participants who intend to donate sperm during the course of this study or 120 days after receiving their last dose of study drug.
- •Female participants who are lactating and breastfeeding or have a positive serum pregnancy test during the Screening period or a positive urine pregnancy test on Day 1 before administration of the first dose of study drug
研究者
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