EUCTR2019-003826-25-IT进行中（未招募）1 期
PRESERVE 1: A Phase 3 Randomized, Double-blind Trial of Trilaciclib versus Placebo in Patients Receiving FOLFOXIRI/Bevacizumab for Metastatic Colorectal Cancer - PRESERVE 1
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
- 296
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
- •1. Age = 18 years of age at the time of signing the informed consent. Patients > 70 years of age must have a G8 Health State Screening Tool (geriatric screening tool) score > 14.
- •2. Proficient mismatch repair/microsatellite stable (pMMR/MSS), histologically or cytologically-confirmed adenocarcinoma of the colon or rectum. Patients with any BRAF or KRAS mutation status are eligible.
- •3. Unresectable and measurable or evaluable disease per RECIST v1.1
- •4. ECOG performance status of 0 to 1
- •5. A formalin-fixed paraffin-embedded (FFPE) tumor specimen (from archival or fresh biopsy) with an associated pathology report documenting pMMR/MSS mCRC must be confirmed to be available to send to the Sponsor for planned retrospective biomarker analyses
- •6. Hemoglobin = 9.0 g/dL in the absence of RBC transfusion or ESA administration within 14 days prior to first dose of trilaciclib/placebo
- •7. Absolute neutrophil count (ANC) = 1.5 × 109/L
- •8. Platelet count = 100 × 109/L
- •9. Estimated glomerular filtration rate (eGFR) = 30 mL/minute/1.73m2
- •10. Serum creatinine = 1.5 mg/dL or creatinine clearance = 30 mL/minute
- •11. Total bilirubin = 1.5 × upper limit of normal (ULN)
- •12. AST, ALT, and alkaline phosphatase = 3 × ULN for patients without liver or bone metastases; AST, ALT and alkaline phosphatase = 5 × ULN in the presence of liver metastases; AST and ALT = 3 x ULN and alkaline phosphatase = 5 × ULN in the presence of bone metastases
- •13. Resolution of nonhematologic toxicities from prior therapy or surgical procedures to = Grade 1 or baseline (except alopecia)
- •14. Urine dipstick protein < 2+. If = 2+ at Screening, then a 24-hour urine collection must be done to demonstrate = 1 g of protein/24 hours
- •15. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •16. Capable of giving signed informed consent which includes compliance with the requirements
- •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 207
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 89
排除标准
- •1. Prior systemic therapy for mCRC. Patients who received adjuvant/neoadjuvant therapy (ie, treatment with curative intent) for colorectal cancer are eligible if it has been = 6 months between the last dose of systemic chemotherapy and the date of informed consent.
- •2. Any radiotherapy, chemotherapy, immunotherapy, biologic, investigational, or hormonal therapy for cancer treatment (except for adjuvant hormonal therapy for breast cancer or prostate cancer defined as M0 disease or PSA persistence/recurrence without metastatic disease) within 3 weeks prior to the first dose of trilaciclib/placebo.
- •3. Receipt of any low-dose systemic chemotherapeutic agent (e.g., lowdose methotrexate for rheumatoid arthritis) administered for a nononcologic purpose within 3 weeks prior to the first dose of trilaciclib/placebo.
- •4. Presence of central nervous system (CNS) metastases/leptomeningeal disease requiring immediate treatment with radiation therapy or steroids (i.e., patient must be off steroids administered for brain metastases for at least 14 days prior to the first dose of trilaciclib/placebo).
- •5. QTcF interval > 450 msec (males) or > 470 msec (females) at screening (confirmed on repeat). For patients with ventricular pacemakers, QTcF > 500 msec.
- •6. Personal or family history of long QT syndrome
- •7. Symptomatic peripheral neuropathy
- •8. History of interstitial lung disease (ILD)
- •9. Uncontrolled hypertension (blood pressure = 150/90mm Hg)
- •10. Clinically significant (i.e., active) cardiovascular disease at the time of signing the informed consent; for example cerebrovascular accidents (= 6 months before the first dose of trilaciclib/placebo), myocardial infarction (= 6 months before the first dose of trilaciclib/placebo), unstable angina, serious cardiac arrythmia requiring medication, or uncontrolled symptomatic congestive heart failure [Class II or higher as defined by the New York Heart Association [NYHA] functional classification system])
- •11. Serious, non-healing wound, ulcer, or bone fracture
- •12. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study.
- •13. Known serious active infection (e.g., human immunodeficiency virus [HIV], hepatitis B or C, tuberculosis, etc.)
- •14. Known Gilbert's Syndrome or homozygous for the UGT1A1*28 allele. UGT1A1 genotyping is not required for this study.
- •15. Chronic inflammatory bowel disease and/or active intestinal obstruction. Patients should not be treated until the intestinal obstruction has resolved.
- •16. Previous history of significant/severe hemorrhage, within 1 month before randomization.History of previous abdominal fistula or gastrointestnal perforation within 6 months before randomization.
- •17. Known history of bleeding diathesis or coagulopathy
- •18. Treatment with any anti-thrombolytic agent (e.g. tissue plasminogen activator [TPA]) or anticoagulants for anti-thrombotic therapeutic purposes within 10 days prior to first dose of study treatment.
- •18. INR> 1.5 within 14 days prior to strating study treatment. EXEMPTION: patients on full anticoagulation must have an in-range INR
- •(usually between 2 to 3). Any anticoagulation therapy must be at stable dosing prior to enrollment.
- •19.Ongoing or anticipated treatment with potent cytochrome inhibitors CYP450 3A4 (such as ketoconazole) or inducers (such as rifampicin,
- •carbamazepine, phenobarbital, phenytoin or St. Joh
研究者
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