EUCTR2016-004466-26-BE进行中（未招募）1 期
Phase 2 Study of the Safety, Efficacy, and Pharmacokinetics of G1T28 in Patients with Metastatic Triple Negative Breast Cancer Receiving Gemcitabine and Carboplatin Chemotherapy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
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
- •For a patient to be eligible for participation in this study, all of the following criteria must apply.
- •1. Female or male patients with Stage IV metastatic or locally recurrent TNBC
- •2. Age = 18 years
- •3. Histologically or cytologically confirmed hormone (estrogen and progesterone) receptor negative tumor on local pathology IHC assessment (defined as < 10% nuclei staining) and human epidermal growth factor receptor 2 (HER2)-negative, nonoverexpressing, by IHC (0 or 1+) or negative, nonamplified, by fluorescent in situ hybridization (ratio < 2.0) per local assessment
- •4. Patients must have tumor tissue available from their TNBC diagnostic sample (archived tissue allowed) for retrospective analysis of potential biomarkers
- •5. At least 1 target lesion that is measurable by RECIST, Version 1.1 (Eisenhauer et al. 2009)
- •6. Hemoglobin = 9.0 g/dL in absence of RBC transfusion within 14 days prior to first dose of trilaciclib
- •7. ANC = 1.5 × 109/L
- •8. Platelet count = 100 × 109/L
- •9. Serum creatinine = 1.5 mg/dL or creatinine clearance = 60 mL/minute
- •10. Total bilirubin = 1.5 × upper limit of normal (ULN); < 3 × ULN if the patient has documented Gilbert’s disease
- •11. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 × ULN; = 5 × ULN in the presence of liver metastases
- •12. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- •13. Resolution of nonhematologic toxicities from prior therapy or surgical procedures to = Grade 1 (except alopecia)
- •14. Predicted life expectancy of = 3 months
- •15. Contraception:
- •a. For females: All females of childbearing potential must have a negative serum beta human chorionic gonadotropin (ß hCG) test result at screening. Females must be either postmenopausal, surgically sterile, or agree to use 2 forms of highly effective contraception during the study and for 6 months following discontinuation of study treatment
- •i. Postmenopausal is defined as at least 60 years of age, medically confirmed ovarian failure, younger than 60 years of age and have had cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause, and/or serum levels of estradiol and follicle stimulating hormone within the laboratory’s reference range for postmenopausal females
- •ii. Acceptable surgical sterilization techniques are complete or partial hysterectomy or bilateral tubal ligation with surgery at least 6 months prior to dosing, and bilateral oophorectomy with surgery at least 2 months prior to dosing
- •iii. Highly effective methods of contraception are those that result in a low failure rate (ie, less than 1% per year) when used consistently and correctly. These include the following:
- •1. Established use of oral, injected or implanted hormonal methods of contraception (stable dose at least 3 months prior to dosing)
- •2. Placement of an intrauterine device or intrauterine system
- •3. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository. Barrier methods alone (without spermicide) are not acceptable methods. Likewise, spermicide alone is not an acceptable method
- •4. Male sterilization (with the appropriate post vasectomy documentation of the absence of sperm in the ejaculate). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject
- •5. True abstinence, when this is in line with
排除标准
- •1. More than 1 prior chemotherapy regimen for locally recurrent or metastatic TNBC (non-cytotoxic therapies are not considered prior chemotherapy)
- •2. Patients with prior treatment of locally recurrent or metastatic breast cancer with gemcitabine, carboplatin, or cisplatin. (Previous adjuvant/neoadjuvant chemotherapy with carboplatin, cisplatin, or gemcitabine is allowed if = 12 months have elapsed between the date of last adjuvant/neoadjuvant chemotherapy administration and first documented local or distant disease recurrence)
- •3. Less than 12 months between the date of last adjuvant/neoadjuvant chemotherapy administration (with curative intent) and first documented local or distant disease recurrence
- •4. Malignancies other than TNBC within 3 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
- •5. Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Patients with a history of CNS metastases or cord compression are eligible if they have been definitively treated (eg, radiotherapy, stereotactic surgery) and are clinically stable for at least 28 days prior to the first dose and have been off corticosteroids for at least 4 weeks. Steroids for physiological replacement, as antiemetics, by inhalation, and short course of oral/topical steroids given for allergic reactions or asthma flares are allowed
- •6. Uncontrolled ischemic heart disease or uncontrolled symptomatic congestive heart failure (Class III or IV as defined by the New York Heart Association [NYHA] functional classification system)
- •7. Known history of stroke or cerebrovascular accident within 6 months prior to first dose of trilaciclib
- •8. Known serious active infection (eg, human immunodeficiency virus [HIV], hepatitis B or C, tuberculosis, etc.)
- •9. Other uncontrolled serious chronic disease or psychiatric condition that in the investigator’s opinion could affect patient safety, compliance, or follow-up in the protocol
- •10. Prior hematopoietic stem cell or bone marrow transplantation
- •11. Concurrent radiotherapy to any site or radiotherapy within 2 weeks prior to the first dose of trilaciclib
- •12. Receipt of any investigational medication within 30 days prior to the first dose of trilaciclib
- •13. Receipt of any cytotoxic chemotherapy within 3 weeks prior to the first dose of trilaciclib
- •14. Hypersensitivity to cisplatin or other platinum-containing compounds, or mannitol
- •15. Pregnant or lactating women
研究者
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