EUCTR2010-018837-23-GB进行中（未招募）不适用
A randomised Phase II study of carboplatin with or without the addition of the ETAR inhibitor ZD4054 as treatment for patients with metastatic breast cancer. - PLANET
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •The main inclusion criteria for this trial are as follows:
- •1) Patients aged over 18 years
- •2) Histological or cytological diagnosis of metastatic breast cancer, or previous histological diagnosis of breast cancer and evidence of metastatic or locally advanced disease unsuitable for local therapy.
- •3) No more than 2 prior lines of chemotherapy treatment for metastatic breast cancer.
- •4) Life expectancy greater than 3 months
- •5) Patients must have previously received or be ineligible for a taxane
- •6) Informed consent
- •7) Adequate bone marrow and hepatic function.
- •8) Haemoglobin = 9.0 g/dl (if no prior transfusion or transfusion more than 4 weeks previously) or = 10.0 g/dl (transfusion within last 4 weeks), absolute neutrophil count = 1.5 x 109/L, platelets =100 x 109/L;
- •9) Total bilirubin < 1.5 x upper normal limit;
- •10) AST and ALT = 2.5 x upper normal limit (or = 5x UNL in the presence of liver metastases);
- •11) Adequate renal function.
- •12) GFR =60mls/min calculated using Wright Formula or measured by EDTA plasma clearance (See 10.1 and Appendix 3).
- •13) At least one measurable lesion on CT scanning. Disease measurable by other RECIST v1.1 compatible imaging (e.g. MRI, CXR) or clinically measurable will be allowed as long as the same assessment method is used throughout the trial.
- •14) ECOG performance status =2.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •The main exclusion criteria for this trial are as follows:
- •1) Previous treatment with platinum based chemotherapy.
- •2) Previous treatment with ZD4054.
- •3) Co-existing active infection or serious concurrent medical condition.
- •4) Significant cardiovascular disease defined as:
- •history of congestive heart failure requiring therapy (NHYA grade 2 or higher);
- •history of unstable angina pectoris or myocardial infarction up to 6 months prior to trial entry;
- •presence of severe valvular heart disease;
- •presence of a ventricular arrhythmia requiring treatment.
- •5) Any co-existing medical condition that, in the investigator’s judgement, may substantially increase the risk associated with the patient’s participation in the study or potentially hamper compliance with the study protocol and follow-up schedule.
- •6) Known brain or leptomeningeal metastases.
- •7) Gastrointestinal disorders likely to interfere with absorption of the study drug.
- •8) Patients known to be serologically positive for Hepatitis B or Hepatitis C (mandatory testing not required).
- •9) Immunocompromised patients e.g. Patients who are known to be serologically positive for human immunodeficiency virus (HIV) (mandatory testing not required).
- •10) Participation in any other interventional clinical study within the previous 4 weeks or during the course of this study.
- •11) Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or compliance with the study protocol.
- •12) Other previous or current malignant disease likely to interfere with protocol treatment or comparisons.
- •13) Concomitant administration of potent CYP3A inhibitors, specifically: Protease inhibitors (atanazavir, indinavir, nelfinavir, ritonavir, saquinavir), Macrolide antibiotics (clarithromycin, telithromycin), Azole antifungals (ketoconazole, itraconazole, voriconazole), nefazodone.
- •14) Concomitant administration of CYP3A inducers, specifically: rifampicin, rifapentine, rifabutin, phenytoin, carbamazepine, phenobarbitol, St John’s Wort. See section 8.5.1.
- •15) Women who are breastfeeding
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