ACTRN12613000556741终止不适用
A randomised phase III double-blind study to evaluate the effect of BBI608 or placebo on overall survival in patients with pretreated advanced colorectal carcinoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 650
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Signed, written informed consent
- •2. Must have histologically confirmed advanced (metastatic or locally advanced) colorectal cancer that is unresectable
- •3. Received a prior thymidylate synthase inhibitor (e.g. 5-fluorouracil (5-FU), capecitabine, raltitrexed, UFT) for metastatic disease or as adjuvant therapy. Thymidylate synthase inhibitor may have been given in combination with oxaliplatin or irinotecan
- •4. Received and failed an irinotecan -containing regimen (i.e. single-agent or in combination) for treatment of metastatic disease, OR relapsed within 6 months of completion of an irinotecan-containing adjuvant therapy, OR have documented unsuitability for an irinotecan-containing regimen
- •5. Received and failed an oxaliplatin-containing regimen (i.e. single-agent or in combination) for treatment of metastatic disease, OR relapsed within 6 months of completion of an oxaliplatin-containing adjuvant therapy OR have documented unsuitability for an oxaliplatin-containing regimen
- •6. For patients with colorectal cancer that is K-ras wild type: Received and failed a cetuximab or panitumumab-containing regimen (i.e. single-agent or in combination) for treatment of metastatic disease OR have documented unsuitability for a cetuximab or panitumumab-containing regimen
- •7. The only remaining standard available therapy as recommended by the Investigator is best supportive care.
- •8. Must have presence of measurable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST 1.1)
- •9. Imaging investigations including CT/MRI of chest/abdomen/pelvis or other scans as necessary to document all sites of disease done within 10. Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •11. Must be greater or equal to 18 years of age
- •12. For male or female patient of child producing potential: Must agree to use contraception or take measures to avoid pregnancy during the study and for 30 days after the last Protocol treatment dose
- •13. Women of child bearing potential (WOCBP) must have a negative serum or urine pregnancy test within 72 hours prior to randomization. The minimum sensitivity of the pregnancy test must be 25 IU/L or equivalent units of HCG
- •14. Must have alanine transaminase (ALT) < 3 × institutional upper limit of normal (ULN) [< 5 × ULN in presence of liver metastases]
- •15. Must have hemoglobin (Hgb) > 80 g/L
- •16. Must have total bilirubin < 1.5 × institutional ULN [< 2.0 x ULN in presence of liver metastases]
- •17. Must have creatinine < 1.5 × institutional ULN or Creatinine Clearance > 50 ml/min
- •18. Must have absolute neutrophil count > 1.5 x 109/L
- •19. Must have platelet count > 75 x 109/L
- •20. Other biochemistry which must be done includes lactate dehydrogenase (LDH) and alkaline phosphatase
- •21. Patient is able (i.e. sufficiently fluent) and willing to complete the Quality of Life and Health Utilities questionnaires in one of the validated languages
- •22. Patients must be accessible for treatment and follow up
- •23. Protocol treatment is to begin within 2 working days of patient randomization
- •24. The patient is not receiving therapy in a concurrent clinical study
排除标准
- •1. Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within four weeks of first dose with the exception of a single dose of radiation up to 8 Gray (equal to 800 RAD) with palliative intent for pain control up to 14 days before randomization
- •2. Major surgery within 4 weeks prior to randomization
- •3. Any known symptomatic brain metastases requiring steroids
- •4. Women who are pregnant or breastfeeding
- •5. Gastrointestinal disorder(s) which, in the opinion of the Qualified/Principal Investigator, would significantly impede the absorption of an oral agent (e.g. active Crohn’s disease, ulcerative colitis, extensive gastric and small intestine resection)
- •6. Unable or unwilling to swallow BBI608/placebo capsules daily
- •7. Patients with a history of other malignancies except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for > 5 years
- •8. Prior treatment with BBI608
- •9. Any active disease condition or intercurrent illness which would render the protocol treatment dangerous or impair the ability of the patient to receive protocol therapy or that would limit compliance with study requirements
- •10. Any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol
研究者
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