A Phase III Study of BBI-608 in combination with 5-Fluorouracil, Leucovorin, Irinotecan (FOLFIRI) in Adult Patients with Previously Treated Metastatic Colorectal Cancer (CRC) - CanStem303C

Boston Biomedical, Inc0 个研究点目标入组 49 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Boston Biomedical, Inc
入组人数: 49

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

年龄范围: 18 至 99（—）

入选标准

•1.1 Written, signed 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
•procedure., 1.2 Must have histologically confirmed advanced CRC that is
•metastatic., 1.3 Must have failed treatment with one regimen containing only a
•fluoropyrimidine and oxaliplatin with or without bevacizumab for metastatic
•disease. All patients must have received a minimum of 6 weeks of the first-line
•regimen that included bevacizumab, oxaliplatin and a fluoropyrimidine with or
•without bevacizumab in the same cycle. Treatment failure is defined as
•radiologic progression during or < 6 months after the last dose of first-line
•therapy., 1.4 FOLFIRI therapy is appropriate for the patient and is recommended
•by the Investigator., 1.5 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., 1.6 Must
•have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or
•1., 1.7 Must be * 18 years of age., 1.8 For male or female patient of child
•bearing potential: 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. Patients who receive single agent BBI-608 without
•FOLFIRI must agree to use contraception or take measures to avoid pregnancy
•during the study and for 30 days for female patients and 90 days for male
•patients, of the final BBI-608 dose. , 1.9 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., 1.10 Must have alanine transaminase (ALT) * 3 ×
•institutional upper limit of normal (ULN) [* 5 × ULN in presence of liver
•metastases] within 14 days prior to randomization., 1.11 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., 1.12
•Must have total bilirubin * 1.5 × institutional ULN [* 2.0 x ULN in presence of
•liver metastases] within 14 days prior to randomization., 1.13 Must have
•creatinine * 1.5 × institutional ULN or Creatinine Clearance > 50 ml/min as
•calculated by the Cockcroft-Gault equation (Chronic Kidney Disease Epidemiology
•Collaboration [CKD-EPI] equation may also be used) within 14 days prior to
•randomization., 1.14 Must have absolute neutrophil count * 1.5 x 109/L within
•14 days prior to randomization., 1.15 Must have platelet count * 100 x 109/L
•within 14 days prior to randomization. Must not have required transfusion of
•platelets within 1 week of baseline platelet assessment., 1.16 Patient must
•have adequate nutritional status with Body Mass Index (BMI) > 18 kg/m2 and body
•weight of > 40 kg with serum albumin > 3 g/dL., 1.17 Other baseline laboratory
•evaluations, listed in Section 5, must be done within 14 days prior to
•randomization., 1.18 Patient must consent to provision of, and Investigator(s)
•must confirm access to

排除标准

•2.1 Anti-cancer chemotherapy or biologic therapy if administered prior to the
•first planned dose of study medication (BBI-608 or FOLFIRI) 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 study
•medication., 2.2 More than one prior chemotherapy regimen administered in the
•metastatic setting., 2.3 Major surgery within 4 weeks prior to randomization.,
•2.4 Patients with any known brain or leptomeningeal metastases are excluded,
•even if treated., 2.5 Women who are pregnant or breastfeeding. Women should not
•breastfeed while taking study treatment and for 4 weeks after the last dose of
•BBI-608 or while undergoing treatment with FOLFIRI and for 180 days after the
•last dose of FOLFIRI., 2.6 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)., 2.7 Unable or unwilling to
•swallow BBI-608 capsules daily., 2.8 Prior treatment with BBI-608 or possible
•hypersensitivity to BBI-608 or one of the excipients which include azo dyes
•sunset yellow and allura red., 2.9 Uncontrolled intercurrent illness including,
•but not limited to, ongoing or active infection, clinically significant
•non-healing or healing wounds, symptomatic congestive heart failure, unstable
•angina pectoris, clinically significant cardiac arrhythmia, significant
•pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled
•infection or psychiatric illness/social situations that would limit compliance
•with study requirements.
•a. Known infection with HIV, and/or active infection with hep B or hep C
•b. patients with clinically significant ascites or pleural effusions, 2.10
•Known hypersensitivity to 5-fluorouracil/leucovorin, 2.11 Known
•dihydropyrimidine dehydrogenase (DPD) deficiency, 2.12 Known hypersensitivity
•to irinotecan, 2.13 Abnormal glucuronidation of bilirubin, known Gilbert*s
•syndrome, 2.14 Patients with QTc interval > 470 milliseconds, 2.15 For
•patients to be treated with a regimen containing bevacizumab: please refer to
•protocol, 2.16 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 tumors curatively treated with no evidence of disease
•for > 3 years., 2.17 Any active disease condition which would render the
•protocol treatment dangerous or impair the ability of the patient to receive
•protocol therapy., 2.18 Any condition (e.g. psychological, geographical, etc.)
•that does not permit compliance with the protocol., Please refer to protocol
•for further information.

研究者

发起方

Boston Biomedical, Inc

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