EUCTR2011-002803-13-DE进行中（未招募）1 期
A Randomized, Phase II Study Evaluating MK-1775 in Combination with Paclitaxel and Carboplatin versus Paclitaxel and Carboplatin Alone in Adult Patients with Platinum Sensitive p53 Mutant Ovarian Cancer - MK1775 in Comb. with Paclitaxel&Carboplatin vs Paclitaxel&Carboplatin Alone
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 119
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
- Female
入选标准
- •(1) Patient must have a histologically confirmed non-low grade, non-borderline (low malignant potential) ovarian cancer which has progressed after paclitaxel / carboplatin therapy.
- •(2) Patients must have platinum sensitive disease. The earliest evidence of progression must have occurred at least 6 months following the completion of the most recent platinum based treatment.
- •(3) Patient is able to provide a baseline tumor sample. The submitted tumor sample must have tested positive for a loss-of-function p53 mutation (as defined in the assay charter) and the result must be documented by a core lab for the study.
- •(4) Part 1 - Patient may not have received more than two platinum containing treatment regimens (paclitaxel / carboplatin) for their cancer. Part 2 - Patient may not have received more than three separate regimens of platinum containing treatment for their cancer.
- •(5) Any biologic therapy or radiation must have been completed four weeks prior to receiving study therapy. With the exception of Grade 1 neurotoxicity, the patient must have recovered from adverse events due to previous agents administered. Biologic maintenance therapy (i.e. bevacizumab) is allowable within this six month period. Any biologic maintenance therapy must have been discontinued 28 days prior to the patient starting study therapy.
- •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 119
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 119
排除标准
- •(1) Patient is currently participating or has participated in a study with an investigational compound or device within 28 days of receiving first dose of study medication.
- •(2) Patients with active CNS metastases and/or carcinomatous meningitis are excluded. However, patients with CNS metastases who have completed a course of therapy would be eligible for the study provided they are clinically stable for 1 month prior to entry as defined as: (1) no evidence of new or enlarging CNS metastasis (2) off steroids or on a stable dose of steroids for at least 2 weeks.
- •(3) Patient with a primary central nervous system tumor.
- •(4) Patient has known hypersensitivity to the components of potential study therapy (paclitaxel, carboplatin, MK-1775) or its analogs (i.e. cremophor, mannitol, etc). The MK-1775 Investigator Brochure can be referenced for information regarding study therapy.
研究者
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