EUCTR2013-002564-69-DE进行中（未招募）1 期
Double-blind, placebo-controlled multicenter phase II trial to evaluate the efficacy and safety of romiplostim for the treatment of chemotherapy-induced thrombocytopenia in subjects with relapsed ovarian cancer (2nd or further line) - T-RACE II
GMIHO Gesellschaft für Medizinische Innovation - Hämatologie und Onkologie mbH0 个研究点目标入组 74 人开始时间: 2014年1月28日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 74
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
入选标准
- •?Women = 18 years of age
- •?Before any study-specific procedure, the appropriate written informed consent must be obtained, according to ICH-GCP, and national/local regulation
- •?ANC = 1,000/µl, Hgb = 9.5 g/dl, and platelet count = 100 x 109/l on day 1 of the first on study cycle of the chemotherapy treatment (on-study cycle) (Thrombocytopenia have to be defined during a qualifying cycle”; qualifying cycle could be the 1st or the 2nd cycle of the palliative chemotherapy; thrombocytopenia as evidenced by a platelet count < 50 x 109/l during the qualifying cycle of chemotherapy OR platelet count < 100 x 109/l on the
- •planned starting day of the next cycle of chemotherapy (or 1-3 days before),
- •requiring dose delay for platelet recovery.)
- •?Subjects with histologically confirmed advanced or metastatic ovarian cancer who are receiving 2nd or 3rd line chemotherapy consisting of one of the following regimens according to established dosing standards:
- •1. Topotecan, d 1-5, q3w
- •2. Gemcitabine, d1+8, q3w
- •3. Carboplatin / paclitaxel, d1, q3w
- •4. Carboplatin d1 / gemcitabine, d1+d8, q3w
- •5. Carboplatin /pegylated liposomal doxorubicin, d1, q4w
- •6. Carboplatin d1 / gemcitabine, d1+d8, Avastin d1, q3w
- •7. Topotecan d1-5 + avastin, q3w
- •8.Carboplatin + paclitaxel + avastin, q3w
- •?Thrombocytopenia as evidenced by a platelet count < 50 x 109/l during the qualifying cycle of chemotherapy OR platelet count < 100 x 109/l on the planned starting day of the next cycle of chemotherapy (or 1-3 days before), requiring dose delay for platelet recovery;
- •qualifying cycle could be the 1st or the 2nd cycle of chemotherapy
- •?Life expectancy = 12 weeks at the time of screening
- •?Ability to receive the same dose and schedule of chemotherapy during the first on study treatment cycle as was given in the qualifying cycle(s). (In case of grade 4 thrombocytopenia: a dose reduction to =75% of the previous dose schedule is allowed.)
- •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 74
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 74
排除标准
- •?Previous treatment with PEG-rHuMGDF, recombinant human thrombopoietin (rHuTPO), romiplostim, eltrombopag, or another thrombopoietic protein
- •?Past or current history of malignancies that affect the overall prognosis (Please note: patients with past or current malignancies not affecting the overall progonosis are allowed for enrolment)
- •?Subjects, who have had a larger surgery within the last 2 weeks before entering this study
- •?Subjects with an active infection; sepsis, disseminated intravascular coagulation, or any other condition (i.e. myelodysplastic syndrome {MDS}, immune thrombocytopenic purpura {ITP}, thrombotic thrombocytopenic purpura {TTP}, hemolytic uremic syndrome {HUS})
- •that may have exacerbated thrombocytopenia
- •?History of unstable angina, CHF {NYHA >class II}, uncontrolled hypertension {diastolic >100mm HG}, uncontrolled cardiac arrhythmia, or recent (within 1 year of screening) myocardial infarction (MI)
- •?History of arterial thrombosis (e.g., stroke or transient ischemic attack) within 1 year of screening
- •?History of pulmonary embolism or other venous thrombosis within 1 year of screening (except for catheter-related clots)
- •?Receipt of any experimental therapy within the last 4 weeks prior to screening; subject is currently enrolled in, or has completed within the last 30 days, another investigational device or drug study (exception: PROVE study)
- •?Receipt of a bone marrow or peripheral blood stem cell infusion (within 1 year of screening)
- •?Positive pregnancy test
- •?Breast feeding period
- •?Reproductive potential and not using adequate highly effective methods of contraceptive precautions in the judgment of the investigator during treatment and for 6 month (male or female) after the end of treatment (adequate: oral contraceptives, intrauterine device or barrier method in conjunction with spermicidial jelly)
- •?Known hypersensitivity to any recombinant E. Coli-derived product or any additives
- •?Inability to comply with the protocol or missing written informed consent
- •?Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and followup schedule; those conditions should be discussed with the subject before registration in the trial.
- •?Accommodation in an institution due to official or legal orders (§40 p. 1 No. 4 AMG)
研究者
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