NCT07782346尚未招募1 期
Phase I Trial to Evaluate Safety and Efficacy of Combination of Liposomal Irinotecan (Nal-IRI; ONIVYDE®) and Cisplatin in Patients With Advanced or Metastatic Solid Malignancies (ICONIC Study)
National Health Research Institutes, Taiwan0 个研究点目标入组 44 人开始时间: 2026年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 主要终点
- Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)
研究概览
简要总结
Phase I trial, Multiple centers, open-label, non-randomized single-arm study
详细描述
To assess the safety and anti-tumor activity of liposomal irinotecan (nal-IRI; ONIVYDE®) and cisplatin in patients with advanced solid malignancies Primary endpoint To find the maximal tolerated dose (MTD) and recommended phase 2 dose (RP2D) of the combination of liposomal irinotecan (nal-IRI; ONIVYDE®) and cisplatin
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Patients with age 20-85 years old.
- •2. Cytologically or histologically confirmed solid malignancies which are locally advanced, recurrent or metastatic diseases. The disease cannot be cured by surgical intervention or local therapies.
- •3. The malignancies are refractory to standard systemic therapy or there is no available systemic therapy.
- •4. Followings are the diseases entities which are limited in each part:
- •a. Dose escalation phase (cohort 1): non-small cell lung cancer, small cell lung cancer, gastric cancer, neuroendocrine carcinoma, biliary tract cancer (including intrahepatic cholangiocarcinoma [CCA], extrahepatic CCA, gallbladder cancer, ampullary cancer), ovarian cancer, esophageal cancer, thymoma or thymic carcinoma.
- •b. Dose expansion phase (cohort 2): only thymic carcinoma.
- •5. Radiologically measurable disease as defined by RECIST v1.
- •6. Baseline ECOG performance status score 0-
- •7. Life expectancy of at least 12 weeks.
- •8. Adequate hematologic parameters, and hepatic and renal functions defined as
- •a. Absolute neutrophil count ≥ 1500 /μL (without growth factor support at least 7 days).
- •b. Platelets ≥ 90000 /μL (evaluated at least 7 days after last platelet transfusion).
- •c. Hemoglobin ≥ 9 g/dL (evaluated at least 14 days after last RBC transfusion).
- •d. Total bilirubin ≤ 1.5X ULN.
- •e. AST/ALT ≤ 2.5X ULN (≤ 5X ULN if attributable to liver metastases).
- •f. serum creatinine ≤ 1.5 x ULN or creatinine clearance rate (CCr) ≥ 50 mL/min (calculated by Cockcroft-Gault formula [CCr={((140-age) x weight [kg])/(72x serum creatinine [mg/dL])}x 0.85 (if female)] or 24-hour urine collection).
- •9. Normal ECG or ECG without any clinical significant findings.
- •10. Able to understand and sign an informed consent (or have a legal representative who is able to do so).
- •11. Women or men of reproductive potential should agree to use an effective contraceptive method.
排除标准
- •1. Patients who have major surgery, radiotherapy or other systemic chemotherapy or immunotherapy within 3 weeks are not eligible. Patients who have palliative radiotherapy will be eligible if the irradiated area does not involve the only lesion of measurable / evaluable disease.
- •2. Patient with history of severe allergy to liposomal irinotecan (nal-IRI; ONIVYDE®) or cisplatin.
- •3. Significant cardiovascular impairment: (1) history of congestive heart failure greater than New York Heart Association (NYHA) Class II, left ventricular ejection fraction< 50%; or (2) unstable angina, myocardial infarction or stroke within 6 months; or (3) uncontrolled cardiac arrhythmia.
- •4. Patients with electrolyte abnormalities that have not been corrected.
- •5. Patients with active metastatic lesions in central nervous system, or need prednisolone ≥ 10 mg/day to control related symptoms
- •6. Patients with active bacterial, fungal, tuberculosis or human immunodeficiency virus infection
- •7. Patients with positive hepatitis B surface antigen (HBsAg) but not receiving anti-hepatitis B drug. Patients who have positive HBsAg, positive anti-HBc, or positive anti-HCV are eligible if the corresponding HBV-DNA or HCV-RNA are undetectable.
- •8. Subjects who have not recovered adequately from any toxicity from other anti-cancer treatment regimens and/or complications from major surgery prior to starting therapy.
- •9. Patients who have peripheral neuropathy > grade I of any etiology.
- •10. Patients who have serious concomitant systemic disorders incompatible with the study, i.e. poorly controlled diabetes mellitus, auto-immune disorders, or other condition that in the opinion of the investigator would preclude the subject's participation in the study.
- •11. Patients who have other prior or concurrent malignancy except for adequately treated in situ carcinoma or basal cell carcinoma of skin, or any malignancy which remains disease-free for 3 or more years after curative treatment.
- •12. Females who are breastfeeding or pregnant at screening or baseline.
- •13. Patients with psychiatric illness which would preclude study compliance.
- •13. Patients with psychiatric illness which would preclude study compliance.
- •14. Patients who have received any prior treatment with ONIVYDE® (liposomal irinotecan) or irinotecan-containing regimens
结局指标
主要结局
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)
时间窗: During cycle one, approximately 28 days
To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of liposomal irinotecan (nal-IRI) in combination with cisplatin in patients with advanced or metastatic solid malignancies.
次要结局
- Objective Response Rate (ORR) by RECIST Version 1.1(up to approximately 5 years)
- Progression-Free Survival (PFS)(up to approximately 5 years)
- Safety Profile(From initiation of study treatment through 30 days after the end of study treatment.)
- Overall survival (OS)(up to approximately 5 years)
- Objective Response Rate (ORR)(Every 8 weeks from treatment initiation until documented disease progression, withdrawal, death, or end of study participation, up to approximately 5 years.)
研究者
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