NL-OMON40143招募中2 期
Phase Ib/II study of metformin in combination with carboplatin/paclitaxel chemotherapy in patients with advanced ovarian cancer - OVMET
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 124
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
- •Patients with advanced stage (FIGO III-IV), histologically confirmed and documented epithelial ovarian carcinoma
- •Patients eligible for neoadjuvant carboplatin/paclitaxel chemotherapy prior to surgical debulking (phase 1 or 2) OR patients with relapsed or progressive ovarian cancer after initial treatment eligible for palliative carboplatin/paclitaxel chemotherapy (phase 1 only)
- •Measurable tumour according to RECISTv1.1 or GCIG CA125 criteria (phase 2 only)
- •Eastern Cooperative Oncology Group-performance status (ECOG-PS) of 0-2
- •Age >= 18 years
- •Adequate blood count, hepatic and renal function
- •Written informed consent
排除标准
- •Prior chemotherapy, immunotherapy, targeted agents or radiotherapy to abdomen or pelvis (phase 2 only)
- •Current or recent (within 30 days of first study dosing) treatment with another investigational drug or participation in another investigational study.
- •Metformin within 4 weeks prior to enrolment.
- •Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer (phase 2 only)
- •Symptomatic CNS metastasis
- •Pre-existing peripheral neuropathy >= CTC grade 2.
- •Pregnant or lactating females. Serum pregnancy test to be assessed within 7 days prior to study treatment start, or within 14 days with a confirmatory urine pregnancy test within 7 days prior to study treatment start.
- •Women of childbearing potential (defined as <2 years after last menstruation and not surgically sterile) not using effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly) during the study and for 6 months after the last study medication.
- •Known hypersensitivity to any of the study drugs or excipients.
- •Serious active infection requiring i.v. antibiotics at enrolment.
- •Unstable medical conditions.
研究者
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