NL-OMON47848已完成2 期
Phase II and Pharmacological Study with Wee-1 inhibitor AZD1775 Combined with Carboplatin in Patients with p53 Mutated Epithelial Ovarian Cancer that Show Early Relapse (<3 months) or Progression during Standard First Line Treatment with Carboplatin - Paclitaxel Combination Therapy. With an additional safety and preliminary anti-tumor activity cohort of Wee-1 inhibitor AZD1775 Combined with Carboplatin in Patients with p53 Mutated Epithelial Ovarian Cancer, non-small cell lung cancer (NSCLC), sm - M10 MKO (NKI name of trial) AZD1775
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 56 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
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
- •Inclusion criteria for phase II POP trial:
- •1. p53 mutated (determined by IHC and later by sequencing) epithelial ovarian cancer
- •2. measurable disease on CT scan or elevated CA-125 levels that can be monitored
- •3. patients previously received standard 1st line platinum therapy (combined with paclitaxel) for epithelial ovarian cancer, and showed recurrence on or within 3 months of this treatment
- •4. age > 18 years
- •5. WHO performance status lower or equal to 1;Additional inclusion criteria for the safety and activity cohort:
- •1. histological or cytological proof of advanced epithelial ovarian cancer, NSCLC, SCLC, cervical and endometrial cancer (with proven p53 mutation).
- •2. previously treated with (standard) (1st) line platinum-based therapy (, and showed recurrence on or within 6 months after the end of this treatment.;3. Patients are allowed to have received second line non-platinum containing therapy after recurrence on 1st line treatment. No more than 2 lines of pre-treatment with cytotoxic chemotherapy are allowed.
- •4. Eligible patients will have p53 mutation determined by sequencing of exons 2-10. See chapter 10 for additional information and Appendix XI +XII
- •5. Able and willing to undergo a fresh tumor biopsy (if p53 status is already known , tumor biopsy is still mandatory) .
排除标准
- •1. symptomatic cerebral or leptomeningeal metastases
- •2. current participation or previous participation in a study with an investigational compound, or chemo- and/or radiotherapy within 28 days of receiving first dose of study medication
- •3. patient must not have prior radiation therapy to more than 30% of the bone marrow and must have recovered for at least 3 weeks from the hematologic toxicity of prior radiotherapy.
- •4. more than 2 prior cytotoxic chemotherapy regimens
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