NL-OMON46924已完成不适用
A phase I followed by a randomized phase II trial of two cycles carboplatin-olaparib followed by olaparib monotherapy versus capecitabine in BRCA-1 or -2 mutated Her2 negative advanced breast cancer as first line treatment (REVIVAL study) - REVIVA
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Histological or cytological proof of advanced cancer pre-treated with maximally one line of systemic chemotherapy in the advanced setting and any line of hormonal therapy for advanced disease, and potentially benefitting from olaparib-carboplatin combination therapy; (prior (neo-) adjuvant chemotherapy is accepted and does not count as one line, since administered in early stage disease);
- •2. Age ><= 18 years;
- •3. Able and willing to give written informed consent;
- •4. WHO performance status of 0, 1 or 2;
- •5. Able and willing to undergo blood sampling for PK and PD analysis;
- •6. Life expectancy > 3 months, allowing adequate follow up of toxicity evaluation and antitumor activity;
- •7. Evaluable disease according to RECIST 1.1 criteria;
- •8. Minimal acceptable safety laboratory values
- •a. ANC of > 1.5 x 10^9 /L
- •b. Hemoglobin of at least 6.2 mM and no transfusion within 28 days
- •c. Platelet count of > 100 x 10^9 /L
- •d. Hepatic function as defined by serum bilirubin < 1.5 x ULN (or <3 xULN in case of known Gilbert syndrome) , ASAT and ALAT < 2.5 x ULN (or <5 xULN in case of liver metastasis)
- •e. Renal function as defined by serum creatinine < 1.5 x ULN or creatinine clearance > 50 mL/min (by Cockcroft-Gault formula);
- •9. Negative pregnancy test (urine/serum) for female patients with childbearing
排除标准
- •1. Any treatment with investigational drugs within 28 days prior to receiving the first dose of investigational treatment; or 21 days for standard (neo-)adjuvant chemotherapy, hormonal and immunotherapy;
- •2. Patients who have received high dose alkylating agents or a PARP1 inhibitor or carboplatin pretreatment; unless no progression on carboplatin had been observed during earlier treatment and the last carboplatin administration had been longer than 6 months ago.
- •3. Any current treatment with drugs that induce or inhibit the CYP3A4 system : http://www.fda.gov/drugs/developmentapprovalprocess/developmentresources/druginteractionslabeling/ucm093664.htm#inVivo or APPENDIX IX
- •4. Women who have a positive pregnancy test (urine/serum) and/or who are breast feeding;
- •5. Unreliable contraceptive methods. Women and men enrolled in this trial must agree to use a reliable contraceptive method throughout the study (adequate contraceptive methods are: oral, injected or implanted hormonal methods, intra-uterine devices or systems, condom or other barrier contraceptive measures, sterilization and true abstinence)
- •6. Radiotherapy within the last four weeks prior to receiving the first dose of investigational treatment; except 1x8 Gy for pain palliation then a seven days interval should be maintained;
- •7. Uncontrolled infectious disease or known Human Immunodeficiency Virus HIV-1 or HIV-2 type patients;
- •8. Patients with known active hepatitis B or C;
- •9. Recent myocardial infarction (< six months) or unstable angina;
- •10. Symptomatic brain metastases. If adequately treated with resection and/or irradiation and patients are at least four weeks completely free of symptoms of these metastases and without medication related to these metastases patients could be eligible if all other in- and exclusion criteria are obeyed.
- •11. Known leptomeningeal metastases.
- •12. Patients with myelodysplatic syndrome or acute myeloid leukemia
- •13. Any medical condition not yet specified above that is considered to possibly, probably or definitely interfere with study procedures, including adequate follow-up and compliance and/or would jeopardize safe treatment.
研究者
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