NL-OMON41094撤回2 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 - ABI-007-NSCL-006
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 22
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.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
- •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
- •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
- •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.
排除标准
- •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
- •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 IIIV).
- •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
- •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
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