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临床试验/EUCTR2020-000613-32-FR
EUCTR2020-000613-32-FR招募中1 期

A Phase III, Randomized, Open-Label Clinical Study of Napabucasin in Combination with FOLFIRI and Best Supportive Care (BSC) Versus Napabucasin plus BSC (or BSC alone) in Adult Patients with Previously Treated Metastatic Colorectal Cancer (CRC)

1Globe Health Institute0 个研究点目标入组 668 人开始时间: 2024年4月23日最近更新:
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试验速览

阶段
1 期
状态
招募中
发起方
入组人数
668
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

入排标准

性别
All

入选标准

  • •Written, signed informed consent for trial participation must be obtained from the patient appropriately in accordance with applicable ICH guidelines and local and regulatory requirements prior to the performance of any study-specific test or procedure.
  • •Must have histologically confirmed adenocarcinoma of the colon or rectum that is metastatic (Stage IV). Patients with more than a single primary CRC adenocarcinoma will be excluded.
  • •Must have failed standard chemotherapy-based regimens containing a fluoropyrimidine, irinotecan and oxaliplatin.
  • •Patients who are candidates for and have access to anti-VEGF therapy (i.e. bevacizumab and regorafenib) and anti-EGFR therapy (i.e. cetuximab or panitumumab) and TAS-102 must have received appropriate therapy.
  • •Imaging investigations, including CT/MRI of chest/abdomen/pelvis or other scans as necessary to document all sites of disease, performed within 21 days prior to randomization. Patients with either measurable disease or non-measurable evaluable disease are eligible.
  • •Must have ECOG Performance Status of 0 or 1, assessed within 14 days prior to randomization. For patients whose ECOG Performance Status is assessed > 7 days prior to randomization, the ECOG PS must not increase within 7 days prior to randomization. Two observers qualified to perform assessment of the performance status will be required to perform this assessment. If discrepant, the one with the most deteriorated performance status will be considered true.
  • •Must be = 18 years of age.
  • •Must have life-expectancy of > 12 weeks.
  • •For male or female patients of child producing potential: Must agree to use contraception or take measures to avoid pregnancy during the study and for 30 days for female and 90 days for male patients, of the final napabucasin dose. Arm 1 patients must agree to use contraception or take measures to avoid pregnancy during the study and for 180 days for female and for male patients, of the final FOLFIRI dose.
  • •Women of child bearing potential (WOCBP) must have a negative serum or urine pregnancy test within 5 days prior to randomization. The minimum sensitivity of the pregnancy test must be 25 IU/L or equivalent units of HCG.
  • •Must have alanine transaminase (ALT) = 3 × institutional upper limit of normal (ULN), or = 5 × ULN in presence of liver metastases within 14 days prior to randomization.
  • •Must have hemoglobin (Hgb) = 9.0 g/dL within 14 days prior to randomization. Must not have required transfusion of red blood cells within 1 week of baseline Hgb assessment.
  • •Must have total bilirubin = 1.5 × institutional ULN, or = 2.0 × ULN in presence of liver metastases within 14 days prior to randomization.
  • •Must have creatinine = 1.5 × institutional ULN and Creatinine Clearance > 50 mL/min (as calculated by the Cockroft-Gault equation) within 14 days prior to randomization. Actual body weight should be used for calculating creatinine clearance. For patients with a Body Mass Index (BMI) > 30 kg/m2, lean body weight should be used instead.
  • •Must have absolute neutrophil count = 1.5 × 109/L within 14 days prior to randomization.
  • •Must have platelet count = 100 × 109/L within 14 days prior to randomization. Must not have required transfusion of platelets within 1 week of baseline platelet assessment.
  • •Patients must have adequate nutritional status with Body Mass Index (BMI) > 18 kg/m2 and body weight of > 40 kg with serum albumin = 3.0 g/dL. Patients must not be candidates for en

排除标准

  • •Anti-cancer chemotherapy, biologic therapy or any other systemic therapy if administered prior to the first planned dose of study medication within period of time equivalent to the usual cycle length of the regimen. An exception is made for oral fluoropyrimidines (e.g. capecitabine, S-1), where a minimum of 10 days since last dose must be observed prior to the first planned dose of protocol treatment. Radiotherapy, immunotherapy (including immunotherapy administered for non-neoplastic treatment purposes), or investigational agents within four weeks of first planned dose of study medication, with the exception of limited field radiation up to 14 days before randomization.
  • •Major surgery within 4 weeks prior to randomization. Major surgery is defined as any invasive operative procedure in which a more extensive resection is performed, e.g. a body cavity is entered, organs are removed, or normal anatomy is altered. If a mesenchymal barrier is opened (pleural cavity, peritoneum, meninges), the surgery is considered major.
  • •Patients with any known brain or leptomeningeal metastases are excluded, even if treated.
  • •Women who are pregnant or breastfeeding.
  • •Gastrointestinal disorder(s) which would significantly impede the absorption of an oral agent (e.g. intestinal occlusion, Crohn’s disease, ulcerative colitis, extensive gastric and small intestine resection).
  • •Unable or unwilling to swallow napabucasin capsules daily.
  • •Prior treatment with napabucasin or participation on a napabucasin clinical trial or possible hypersensitivity to napabucasin or one of the excipients which include azo dyes sunset yellow and allura red.
  • •Uncontrolled intercurrent illness
  • •Known history of human immunodeficiency virus (HIV) infection. Known chronic hepatitis B or C active infection.
  • •Patients with clinically significant ascites or pleural effusions (e.g., requiring fluid removal within 2 months before randomization, and/or frequent or large volume removal, or requiring an indwelling drainage catheter).
  • •Patients with hereditary non-polyposis colorectal cancer (HNPCC or Lynch syndrome) or familial adenomatous polyposis syndrome (FAP).
  • •The MSI/MSS status of the tumor must be known prior to randomization. Patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) status will be excluded.
  • •Known hypersensitivity to fluoropyrimidine or patients who as a result of toxicity had to reduce or stop 5-FU infusion at the dose of 900 mg/m2/day (total 1800 mg/m2/day).
  • •Known dihydropyrimidine dehydrogenase (DPD) deficiency.
  • •Known hypersensitivity to irinotecan or patients who as a result of toxicity had to reduce or stop irinotecan infusion at the dose of <120 mg/m2.
  • •Patients receiving treatment with St. John’s wort or Phenytoin.
  • •Patients who plan to receive yellow fever vaccine during the course of the study treatment.
  • •Abnormal glucuronidation of bilirubin, known Gilbert’s syndrome.
  • •Patients with QTc interval > 470 millisecond.
  • •Patients who consumed cigarettes/tobacco within 28 days prior to randomization or plan to use these products while on study treatment.
  • •Patients with a history of other malignancies including concurrent colorectal co-primary tumor and except for: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with surgery or surgery with radiotherapy and/or chemotherapy with no evidence of disease

研究者

发起方
1Globe Health Institute

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