EUCTR2014-001105-41-FR进行中（未招募）1 期
A Phase 2, randomized, open-label, multicenter study to assess safety and efficacy of nab-paclitaxel (ABI-007) with epigenetic modifying therapy of CC-486, and nab-paclitaxel monotherapy as second-line treatment in subjects with advanced nonsquamous non-small cell lung cancer (NSCLC): ABOUND.2L - ABOUND.2
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
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
- •Subjects must satisfy the following criteria to be randomized in the study:
- •1.Age = 18 years the time of signing the Informed Consent Form (ICF).
- •2.Understand and voluntarily provide written informed consent prior to the conduct of any study related assessments/procedures.
- •3.Able to adhere to the study visit schedule and other protocol requirements
- •4.Histologically or cytologically confirmed advanced nonsquamous NSCLC.
- •5.No other current active malignancy requiring anticancer therapy.
- •6.Radiographically documented measurable disease (defined by the presence of = 1 radiographically documented measurable lesion).
- •7.One prior platinum-containing chemotherapy for the treatment of advanced disease.
- •8.Absolute neutrophil count (ANC) = 1500 cells/mm3.
- •9.Platelets = 100,000 cells/mm3.
- •10.Hemoglobin (Hgb) = 9 g/dL.
- •11.Aspartate transaminase (AST/serum glutamic oxaloacetic transaminase [SGOT]) and alanine transaminase (ALT/serum glutamic pyruvic transaminase [SGPT]) = 2.5 × upper limit of normal range (ULN) or = 5.0 × ULN if liver metastases.
- •12.Total bilirubin = 1.5 ULN (unless there is a known history of Gilberts Syndrome).
- •13.Serum creatinine = 1.5 x ULN, or calculated creatinine clearance = 60 mL/min (if renal impairment is suspected 24-hour urine collection for measurement is required).
- •14.Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- •15.Females of childbearing potential [defined as a sexually mature woman who (1) have not undergone hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or (2) have not been naturally postmenopausal for at least 24 consecutive months (ie, has had menses at any time during the preceding 24 consecutive months)] must:
- •a.Have a negative pregnancy test (ß-hCG) as verified by the study doctor within 72 hours prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy. This applies even if the subject practices true abstinence* from heterosexual contact.
- •b.Either commit to true abstinence* from heterosexual contact or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting investigational product (IP), during the study therapy (including dose interruptions), and for 3 months after discontinuation of study therapy.
- •Male subjects must:
- •a.Practice true abstinence* or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 6 months following IP discontinuation, even if he has undergone a successful vasectomy.
- •16.Females must abstain from breastfeeding during study participation and 3 months after IP discontinuation.
- •*True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. [Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception].
- •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 112
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 48
排除标准
- •The presence of any of the following will exclude a subject from enrollment:
- •1.Squamous cell NSCLC.
- •2.Prior taxane therapy.
- •3.Evidence of active brain metastases, including leptomeningeal involvement (prior evidence of brain metastasis are permitted only if asymptomatic and clinically stable for at least 8 weeks following completion of therapy). MRI of the brain (or CT scan w/contrast) is preferred.
- •4.Only evidence of disease is non-measurable.
- •5.Known EGFR mutation.
- •6.Known EML4-ALK mutation.
- •7.Preexisting peripheral neuropathy of Grade > 2 (per NCI CTCAE v4.0).
- •8.Venous thromboembolism within 1 month prior to Cycle 1 Day 1.
- •9.Current congestive heart failure (New York Heart Association Class II-IV).
- •10.History of the following within 6 months prior to Cycle 1 Day 1: a myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically significant electrocardiogram (ECG) abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder.
- •11.Known hepatitis B or C virus (HBV/HCV) infection, known history of human immunodeficiency virus (HIV) infection, or receiving immunosuppressive or myelosuppressive medications that would in the opinion of the investigator, increase the risk of serious neutropenic complications.
- •12.Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment.
- •13.History of interstitial lung disease, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, or pulmonary hypersensitivity pneumonitis.
- •14.Subject has a clinically significant malabsorption syndrome, persistent diarrhea, or known sub-acute bowel obstruction > NCI CTCAE Grade 2, despite medical management.
- •15.Treatment with any investigational product within 28 days prior to signing the ICF.
- •16.History of or suspected allergy to nab-paclitaxel, azacitidine, human albumin or mannitol.
- •17.Currently enrolled in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or therapeutic devices.
- •18.Any other clinically significant medical condition, psychiatric illness, and/or organ dysfunction that will interfere with the administration of the therapy according to this protocol or which, in the views of investigator, preclude combination chemotherapy.
- •19.Any other malignancy within 5 years prior to randomization, or advanced malignant hepatic tumors, with the exception of adequately treated squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, uteri, non-melanomatous skin cancer, carcinoma in situ of the breast, or incidental histological finding of prostate cancer (TNM Classification of Malignant Tumours (TNM) stage of T1a or T1b). (All treatment of which should have been completed 6 months prior to signing ICF).
- •20.Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
- •21.Any medical condition that confounds the ability to interpret data from the study.
- •22.Pregnant or breastfeeding females.
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