NCT02826837Unknown1 期
A Phase I/IIa Dose-Escalation Study Evaluating the Safety, Tolerability and Efficacy of LEAC-102 in Combination With FOLFOX + Bevacizumab/Cetuximab in Subjects With Advanced Colorectal Cancer
Taiwan Leader Biotech Corp.0 个研究点目标入组 30 人开始时间: 2022年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 主要终点
- Maximum tolerated dose
研究概览
简要总结
A Phase I/IIa Dose-Escalation Study Evaluating the Safety, Tolerability and Efficacy of LEAC-102 in Combination with FOLFOX + Bevacizumab/Cetuximab in Subjects with Advanced Colorectal Cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged at least 20 years old
- •Histologically or cytologically confirmed measurable and/or evaluable advanced (stage III/IV) colorectal cancer that can be accurately assessed by CT/MRI scan (RECIST v1.1) for which regimen of FOLFOX + Bevacizumab/Cetuximab is arranged by the investigator
- •Subjects may be treatment naïve, or may have received therapy for colorectal cancer.
- •ECOG performance status ≤ 2 and life expectancy ≥ 12 months Note: ECOG = Eastern Cooperative Oncology Group
- •Dated and signed informed consent
排除标准
- •Primary CNS malignancies or clinically active CNS metastases Note: CNS = central nervous system
- •Ascertained hypersensitivity to any component of investigational product or FOLFOX + Bevacizumab/Cetuximab that the subject will be treated
- •Any of the following hematologic abnormalities:
- •Hemoglobin < 10.0 g/dL,
- •ANC < 1,500/μL,
- •Platelets < 100,000 /μL Note: ANC = absolute neutrophil count
- •Any of the following serum chemistry abnormalities:
- •Total bilirubin > 1.5 × ULN,
- •AST or ALT > 2.5 × ULN,
- •Gamma-GT > 2.5 x ULN,
- •Alk-P > 2.5 x ULN,
- •serum albumin < 3.0 g/dL,
- •creatinine > 1.5 × ULN,
- •any other ≥ Grade 3 laboratory abnormality at baseline (other than those listed above)
- •Note: ULN = upper limit of normal. AST = aspartate transaminase, ALT: alanine transaminase, Gamma-GT = Gamma-glutamyl transferase, Alk-P = alkaline phosphatase
- •Requirement for ongoing systemic steroid, or immunosuppressive agents
- •Uncontrolled nausea or vomiting or any symptom that would prevent the ability to comply with daily oral LEAC-102 treatment
- •Active clinically serious infection
- •Known history of HIV or hepatitis B or C Note: HIV = human immunodeficiency virus
- •Uncontrolled psychiatric disorder or altered mental status precluding informed consent or necessary testing
- •Consumption of herbal preparations/supplements (except for a daily multivitamin/mineral supplement not containing herbal components) within 2 weeks prior to the start of Cycle 1 of FOLFOX + Bevacizumab/Cetuximab administration
- •Significant cardiovascular disease, including:
- •Active clinically symptomatic left ventricular failure
- •Active hypertension (diastolic blood pressure > 100 mmHg). Subjects with a history of hypertension must have been on stable doses of anti-hypertensive drugs for ≥ 4 weeks prior to start of Cycle 1 of FOLFOX + Bevacizumab/Cetuximab administration
- •Uncontrolled hypertension: Blood pressure >140/90 mmHg on more than 2 antihypertensive medications
- •Myocardial infarction, severe angina, or unstable angina within 12 weeks prior to start of Cycle 1 of FOLFOX + Bevacizumab/Cetuximab administration
- •History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation)
- •Significant gastrointestinal disorder(s) that would, in the opinion of the Principal Investigator, prevent absorption of an orally available agent
- •Has received an investigational agent within 4 weeks of entering this study
- •With any condition judged by the investigator that entering the trial may be detrimental to the subject
- •15 Female with childbearing potential who is lactating or has positive urine pregnancy test at Screening visit
- •Subject with either gender refuses to adopt at least two forms of birth control (at least one of which must be a barrier method) during the study and until 30 days after study treatment.
- •Note: Acceptable forms include:
- •Established use of oral, injected or implanted hormonal methods of contraception.
- •Placement of an intrauterine device (IUD) or intrauterine system (IUS).
- •Barrier methods of contraception: Condom OR Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
- •Subjects with grade 2 or above chronic neuropathy
- •Subjects with known dihydropyrimidine dehydrogenase (DPD) deficiency.
研究组 & 干预措施
LEAC-102 and FOLFOX+Bevacizumab/Cetuximab
Experimental
The subjects will be administered folinic acid (Leucovorin; LV), Fluorouracil (5-FU) and Oxaliplatin (FOLFOX) + Bevacizumab/Cetuximab by intravenous infusion.
Cycles repeat every 2 weeks. Dose and schedule modifications may be made at the treating physician's discretion.
A standard 3+3 trial design will be used for LEAC-102 dose escalation cohorts.The dosing of LEAC-102 will be divided into 3 cohorts, the subjects will receive LEAC-102 every day
Cohort 1: LEAC-102 500 mg capsule, 3 capsules, three times per day for 24 weeks (oral), Cohort 2: LEAC-102 500 mg capsule, 4 capsules, three times per day for 24 weeks (oral), Cohort 3: LEAC-102 500 mg capsule, 5 capsules, three times per day for 24 weeks (oral)
干预措施: LEAC-102 500mg capsule and FOLFOX + Bevacizumab/Cetuximab (Drug)
结局指标
主要结局
Maximum tolerated dose
时间窗: Week 4
First two cycles of FOLFOX + Bevacizumab/Cetuximab for advanced Colorectal Cancer (cycle length = 2 weeks)
次要结局
- Overall survival(Week 24)
- Change in platelet level at all post-treatment visits compared to baseline(Weeks 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22,24)
- Change in serum c-reactive protein level at all post-treatment visits compared to baseline(Weeks 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22,24)
- Incidences of myelosuppression(Weeks Weeks 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22,24)
- Change in white blood cells (WBCs) level at all post-treatment visits compared to baseline(Weeks 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22,24)
- Change in serum inflammatory cytokines level at all post-treatment visits compared to baseline(Weeks 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22,24)
- Progression free survival(Week 24)
- Change in hemoglobin level at all post-treatment visits compared to baseline(Weeks 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22,24)
- Changes in global health/QoL standardized score at post-treatment visits compared to baseline(Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22,24)
- Incidence of adverse events (AEs)(Weeks 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22,24)
- Incidence of serious adverse events (SAEs)(Weeks 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22,24)
- Response rate(Week 24)
研究者
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