EUCTR2017-004261-26-IT进行中（未招募）1 期
RESILIENT: A Randomized, Open Label Phase 3 Study of Irinotecan Liposome Injection (ONIVYDE®) versus Topotecan in Patients with Small Cell Lung Cancer Who Have Progressed on or after Platinum-based First-Line Therapy - NA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 486
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •General Inclusion Criteria
- •1. At least 18 years of age
- •2. Able to understand and provide the study informed consent
- •3. ECOG performance status of 0 or 1
- •4. Life expectancy =12 weeks
- •Disease Specific Inclusion Criteria
- •5. Histopathologically or cytologically confirmed small cell lung cancer according
- •to the International Association for the Study of Lung Cancer (IASLC)
- •histopathological classification. Mixed or combined subtypes according to the
- •IASLC are not allowed.
- •6. Evaluable disease as defined by RECIST Version 1.1 guidelines (patients with non-target lesions are eligible)
- •7. Radiologically confirmed progression on or after first-line platinum based chemotherapy (carboplatin or cisplatin) or chemo-radiation including platinumbased chemotherapy for treatment of limited or extensive SCLC. In addition to platinum-based regimen, one line of immunotherapy as monotherapy or in combination in first or in second line setting is allowed.
- •8. Recovered from the effects of any prior chemotherapy, surgery, radiotherapy or other anti-neoplastic therapy (recovered to grade 1 or better, with the exception of alopecia, peripheral neuropathy, or ototoxicity).
- •Hematologic, Biochemical and Organ Function Inclusion Criteria
- •9. During the Screening period, adequate bone marrow reserves as evidenced by:
- •a. Absolute neutrophil count > 1,500 cells/µL (1.5 x 109/L) without the use
- •of hematopoietic growth factors within the immediately preceding 14
- •b. Platelet count > 100,000 cells/µL (100 x 109/L);
- •c. Hemoglobin > 9 g/dL; transfusions are allowed
- •10. Adequate hepatic function as evidenced by:
- •a. Serum total bilirubin within normal range for the institution
- •b. Aspartate aminotransferase and alanine aminotransferase = 2.5 x upper
- •limit of normal (ULN) (= 5 x ULN is acceptable if liver metastates is
- •c. Serum albumin =3.0 g/dL (=30 g/L)
- •11. Adequate renal function as evidenced by a serum creatinine = 1.5 x ULN and
- •creatinine clearance =40 mL/min. Actual body weight should be used for
- •calculating creatinine clearance using the Cockcroft-Gault Equation (except for
- •patients with body mass index > 30 kg/m2 when lean body weight should be used instead):
- •Serum Creatinine (mg/min)= (140-Age (years)×(Weight(kg)) ×Sex
- •72× Serum Creatinine (mg/dL)
- •where Sex = 1 for males and 0.85 for females.
- •12. Electrocardiogram without any clinically significant findings at screening, as per investigator’s assessment.
- •Additional Disease Specific Inclusion Criteria
- •13. Patients with certain types of asymptomatic CNS metastases that meet ALL the following criteria are eligible.
- •a.Patients with asymptomatic CNS metastases prior to enrollment
- •b.Prior radiation for CNS metastatic disease is completed =2 weeks prior to enrollment.
- •c. CNS metastases that are stable or have decreased according to the post radiation follow up scan that is conducted at least 4 weeks after
- •completion of radiation treatment for CNS lesion.
- •d. Patients have discontinued corticosteroids or are on stable low-dose steroids (prednisone or equivalent 10 mg daily or less) for at least 1
- •week after completion of radiation for CNS lesion prior to enrollment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 286
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
排除标准
- •1. Any medical or social condition deemed by PI to be likely to interfere with a patient’s ability to sign ICF, cooperate and participate, or interfere with the interpretation of the results
- •2. Pregnant or breast feeding; females of child-bearing potential must test negative for pregnancy at the time of enrollment. Females of childbearing potential are defined as fertile, following menarche and until becoming postmenopausal unless permanently sterile. If necessary, follicle stimulating hormone results >50 IU/L at screening are confirmatory in the absence of a clear postmenopausal history. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
- •Male pt must agree to use condoms. Female pt of reproductive potential must agree to use a highly effective method of birth control.
- •Disease Specific
- •3. Pt with large cell neuroendocrine carcinoma
- •4. Pt who have received any of the following treatments:
- •a. Prior treatment regimens with irinotecan, topotecan or any other topoisomerase I inhibitor including investigational topoisomerase I inhibitors.
- •b. Retreatment with platinum-based regimen after relapse of first-line platinum-containing therapy;
- •c. Any antibody-drug conjugates or molecular targeted agents (e.g. poly ADP-ribose polymerase inhibitors).
- •d. More than one line of prior immunotherapy
- •e. Any other additional regimen of prior cytotoxic chemotherapy.
- •5. Pt with a history (any grade) of immunotherapy induced colitis or pneumonitis, based on clinical assessment and/or confirmed by biopsy
- •6. Pt with any of the following CNS metastases:
- •a. Pt who have developed new or progressive brain metastases within three months following prophylactic and/or therapeutic cranial radiation (whole brain or stereotactic radiation) as defined by imaging
- •b. Pt with symptomatic CNS metastases.
- •c. Pt with carcinomatous meningitis
- •7. Unable to discontinue the use of strong CYP3A4 or UGT1A1 inhibitors at least 1 week or strong CYP3A4 inducers at least 2 weeks prior to receiving the first dose of irinotecan liposome injection
- •8. Have a previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study, except carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta and Tis [carcinoma in situ]) or any previous cancer curatively treated with last specific treatment >3 years ago without evidence of recurrence.
- •9. Investigational therapy administered within 4 weeks, or within a time interval less than at least 5 half-lives (whichever is less) of the investigational agent, prior to the first scheduled day of dosing in this study
- •Hematologic, Biochemical and Organ Function Exclusion Criteria
- •10. Severe cardiovascular and pulmonary disease less than 6 months before inclusion
- •11. New York Heart Association Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure
- •12. Active infection which in the PI’s opinion might compromise the patient’s participation in the trial or affect the study outcome
- •13. Known hypersensitivity to any of the components of irinotecan liposome injection, other liposomal products, or topotecan
- •14. Clinically significant gastrointestinal disorder including hepatic disorders, bleeding, inflammation, occlusion, or diarrhea > grade 1
- •15. Pt who, per PI, are suitable for a 2line platinum-based regimen following relapse after first-line platinum-based therapy.
研究者
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