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临床试验/EUCTR2016-002718-32-IT
EUCTR2016-002718-32-IT进行中（未招募）1 期

A Phase III Randomized, Open-Label Clinical Trial of BBI-608 plus Weekly Paclitaxel versus Weekly Paclitaxel Alone in Patients with Advanced, Previously Treated, Non-Squamous Non-Small Cell Lung Cancer -

BOSTON BIOMEDICAL, INC.0 个研究点目标入组 870 人开始时间: 2021年1月20日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
870
研究概览入排标准研究者记录与标识符相似试验

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

  • •IC 1 Must have histologically or cytologically confirmed non-squamous NSCLC. Patients with mixed
  • •histology must have adenocarcinoma as the predominant morphology according to light microscopy
  • •pathologic diagnosis. Patients with poorly differentiated tumors must have immunohistochemical
  • •(IHC) staining positive for either TTF-1 or NapsinA and negative for p63 or p40.
  • •IC 2 Patients with an EGFR or ALK/ROS1 genetic aberration must have received appropriately targeted
  • •IC 3 Must have progressed following treatment with platinum-based combination chemotherapy for
  • •metastatic disease. (...)
  • •IC 4 Patients who are candidates for immunotherapy must have received either nivolumab or pembrolizumab or a different IND-approved anti-PD1 or anti-PD-L1 therapy.
  • •IC 5 Prior treatment with the approved agents such as pemetrexed and/or erlotinib is permitted, and candidates who have not received a prior approved regimen must be informed that enrollment onto the trial may delay or prevent treatment that has shown a survival benefit in randomized trials.
  • •IC 6 Weekly paclitaxel must be an acceptable treatment option
  • •IC 7 Must have had resolution to Grade = 1 of all clinically significant adverse events from prior therapy, (grade defined according to the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE]); or, the adverse events must be deemed irreversible, and considered not an impediment to participation in the trial according to the investigator.
  • •IC 8 Must have had baseline radiologic imaging evaluation of the chest, abdomen, and pelvis in the 21 days prior to randomization that documents the presence of measurable or non-measurable disease as defined by RECIST 1.1
  • •IC 9 Must submit tumor tissue for correlative analyses
  • •IC 10 Must allow collection and storage of blood samples for correlative analyses
  • •IC 11 Must be at least 18 years of age
  • •IC 12 Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • •IC 13 Must be willing and able to take BBI-608 orally
  • •IC 14 Must have total bilirubin = 1.5 x upper limit of normal (ULN)
  • •IC 15 Must have aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 x ULN; or must have AST and ALT = 5 x ULN if the aminotransferase elevation is due to liver metastases
  • •IC 16 Must have estimated creatinine clearance = 50 mL/min as calculated following a 24 hour urine collection or by using the Cockcroft-Gault formula (Cockcroft-Gault estimation of creatinine clearance = [140-age] * [Wt in kg] * [(0.85 if female) vs (1.0 if male)] / [72 * Cr] where Cr” is serum creatinine in mg/dl); or,
  • •IC 16a Must have estimated creatinine clearance (eCrCl) = 50 mL/min when corrected for body surface area (in m2) as follows:
  • •Corrected estimated creatinine clearance (eCrClcorrected) = (eCrCl) x 1.73 / patient BSA
  • •IC 17 Must have absolute neutrophil count (ANC) = 1.5 x 103/µL (= 1.5 x 109/L)
  • •IC 18 Must have hemoglobin = 9.0 g/dL without transfusion in the prior 7 days
  • •IC 19 Must have platelets =100 x 103/µL (=100 x 109/L) without transfusion in the prior 7 days
  • •IC 20 Must have serum albumin = 3.0 g/dL
  • •IC 21 Must have Body Mass Index (BMI) > 18.5 kg/m2
  • •IC 22 Must have a life expectancy of = 3 months
  • •IC 23 Must be able (i.e. sufficiently fluent) and willing to complete the Quality of Life questionnaires in one of the validated languages for the questionnaires; (...)
  • •IC 24 Patients must be accessible for treatment and follow-up. (...)

排除标准

  • •EC 1 Have squamous sub-type NSCLC as identified by histologic morphology using light microscopy; or,
  • •EC 1a NSCLC with a mixed histologic morphology suggesting a predominance of squamous features; or,
  • •EC 1b NSCLC with poorly differentiated histologic morphology not meeting IC 1
  • •EC 2 Has received systemic treatment with a taxane for advanced/metastatic disease. Patients are also excluded if there was disease progression or recurrence less than 6 months after adjuvant, neo-adjuvant or chemo-radiation therapy that contained a taxane.
  • •EC 3 Has received any systemic anti-cancer therapy within the 14 days prior to randomization
  • •EC 4 Has received radiotherapy within the 28 days prior to randomization, with the exception of palliative radiotherapy to focal lesions for pain or other symptom control up to 8 gy (800 rad)
  • •EC 5 Has brain metastases with evolving neurologic symptoms or a steroid requirement. Patients with brain metastases who are clinically stable and who do not require steroids may be eligible. Patients with known leptomeningeal metastases are excluded, even if treated or asymptomatic
  • •EC 6 Has had major surgery requiring general anesthesia and/or mechanical ventilation within the 28 days prior to randomization; or, intends to have an elective surgical procedure during the course of planned study participation that carries risk other than minimal discomfort. A biopsy is not considered major surgery.
  • •EC 7 Has hypersensitivity to paclitaxel despite re-sensitization procedures or has history of severe hypersensitivity to any paclitaxel excipient, including macrogolglycerol ricinoleate.
  • •EC 8 Has a concurrent malignancy except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and without evidence of recurrence for at least 3 years prior to randomization
  • •EC 9 Has had extensive colonic or small bowel resection such that absorption of oral medications is considered impaired
  • •EC 10 Has known hepatitis B with clinical complications (patients with chronic, controlled, hepatitis B with or without anti-viral therapy and monitored according to 2015 ASCO guideline for hepatitis B monitoring may be eligible)
  • •EC 11 Is currently receiving interferon for known hepatitis C; or has clinically uncontrolled hepatitis C or hepatitis C with significant complications likely to interfere with protocol compliance.
  • •EC 12 Has known human immunodeficiency virus (HIV) infection, acquired immunodeficiency syndrome (AIDS), or an AIDS-related/AIDS-defining illness
  • •EC 13 Has had a myocardial infarction, unstable angina, stroke, transient ischemic attack, or other major vascular complication in the 6 months prior to randomization
  • •EC 14 Has clinically relevant congestive heart failure (CHF; NYHA II-IV)
  • •EC 15 Has a corrected QT interval (QTc) > 470 ms or has an electrocardiogram (ECG) with a new abnormal finding that is clinically significant. Patients with a known cardiac arrhythmia that is adequately controlled and not affecting performance status, such as atrial fibrillation, may be eligible. Patients with a pacemaker and no major complications (hospitalization, infection) in the 6 months prior to randomization may be eligible
  • •EC 16 Has active inflammatory enteropathy, Crohn's disease, ulcerative colitis, or other chronic diarrheal illness that is not adequately controlled
  • •EC 17 Has peripheral neuropathy = Grade 2 (NCI-CTCAE).
  • •EC 18 Refuses to complete quality of life questionnaires

研究者

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