EUCTR2015-004281-28-IT进行中（未招募）1 期
Randomized, Double-Blind, Phase 2/3 Study in Subjects with Malignant Pleural Mesothelioma to Assess ADI-PEG 20 with Pemetrexed and Cisplatin (ATOMIC-Meso Phase 2/3 Study) - Phase 2/3 ATOMIC Study of MPM to Assess ADI-PEG 20 with PemCis v3
POLARIS GROUP0 个研究点目标入组 386 人开始时间: 2021年6月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 386
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
- •Histologically proven not resecable MPM of biphasic or sarcomatoid histology. Biphasic MPM is defined using the World Health Organization’s international histological classification of tumors as containing an epithelial and a sarcomatoid component with each component comprising at least 10% of the tumor (Corson 2004, Allen 2005).
- •Naïve to prior chemotherapy or immunotherapy (i.e., this is a first-line systemic therapy study).
- •Measurable disease by modified RECIST criteria for MPM for local pleural disease and RECIST 1.1 criteria for metastatic lesions
- •ECOG performance status of 0 – 1 (Appendix C).
- •Predicted life expectancy of at least 12 weeks.
- •Age = 18 years (there is no upper age limit).
- •Fully recovered from any prior surgery and no major surgery within 4 weeks. Surgery for placement of vascular access devices is acceptable.
- •Subjects and their partners must be asked to use appropriate contraception. They must agree to use two forms of contraception or agree to refrain from intercourse for the duration of the study and for 35 days after last dose of ADI-PEG 20 or for at least six months after treatment with pemetrexed and cisplatin whichever is the longer duration. Females must not be pregnant at the start of the study, and a serum human chorionic gonadotropin (HCG) pregnancy test must be negative before entry into the study. If positive HCG pregnancy test, further evaluation to rule out pregnancy must be performed according to GCP before this patient is claimed eligible.
- •Informed consent must be obtained prior to study initiation.
- •Hemoglobin (HB) > 9.0 g/dL.
- •Absolute neutrophil count (ANC) > 1,500/µL.
- •Platelets > 75,000/µL.
- •Either: (i) serum bilirubin = 1.5 x upper limit of normal (ULN) or (ii) alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or alkaline phosphatase (ALP) = 3 x (ULN) unless raised due to tumor in which case up to 5 x ULN is permissible
- •Serum uric acid = 10 mg/dL (595 µmol/L) (with or without medication control).
- •Creatinine clearance = 40 mL/min (estimated, using Cockcroft and Gault formula). Cisplatin dose adjustment is recommended for subjects with a creatinine clearance between 40 and 59 mL/min (Bennis 2014) as follows: reduce cisplatin dose by 25% for clearance between 50 59.9 mL/min and by 50% for clearance between 40 – 49.9 mL/min.
- •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 116
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 270
排除标准
- •1. Radiotherapy (except for palliative reasons) the previous two weeks before.
- •2. Ongoing toxic manifestations of previous treatments.
- •3. Symptomatic brain or spinal cord metastases (patients must be stable for > 1 month post radiotherapy or surgery).
- •4. Major thoracic or abdominal surgery from which the patient has not yet recovered.
- •5. Serious infection requiring treatment with intravenous antibiotics at the time of study entrance, or an infection requiring intravenous therapy within 7 days prior.
- •6. Known to be serologically positive for human immunodeficiency virus (HIV). Testing to determine possible infection status is not required.
- •7. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III or IV), symptomatic cardiac arrhythmia, previous history of myocardial infarction (unless stable and good ejection fraction on echocardiogram) or psychiatric illness, and social situations that would limit compliance with study requirements.
- •8. Is a participant of, or plans to participate in, another interventional clinical study whilst taking part in this study. Participation in an observational or biomarker study would be acceptable, with prior Sponsor approval.
- •9. Subjects with history of another primary cancer, including co-existent second malignancy, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present in the opinion of the Investigator will not affect patient outcome.
- •10. Allergy to platinum salts.
- •11. Pregnancy or lactation.
- •12. Expected non-compliance.
- •13. Subjects who had been treated with ADI-PEG 20 previously.
- •14. History of seizure disorder not related to underlying cancer.
- •15. ECOG performance status > 2.
- •16. Allergy to pegylated compounds.
- •17. Allergy to E. coli drug products (such as GMCSF).
研究者
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