EUCTR2015-004060-11-IT进行中（未招募）1 期
FORWARD 1: A Randomized, Open Label Phase 3 Study to Evaluate the Safety and Efficacy of Mirvetuximab Soravtansine (IMGN853) Versus Investigator¿s Choice of Chemotherapy in Women with Folate Receptor a-positive Advanced Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer - IMGN853 versus doctor's choice
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 366
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
- •Patients must have been diagnosed with Advanced Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer.
- •Patients must have platinum-resistant ovarian cancer, defined as progression within 6 months from completion of a minimum of four cycles of platinum-containing therapy. This should be calculated from the date of the last administered dose of platinum therapy to the date of the radiographic imaging showing progression.
- •Patients must have at least one lesion that meets the definition of measurable disease by RECIST v1.1.
- •Patients must have received at least one but no more than three prior systemic lines of anti-cancer therapy and for whom single agent chemotherapy is appropriate as the next line of treatment.
- •- Adjuvant±Neoadjuvant will be considered as one line of therapy
- •- Maintenance therapy (example: bevacizumab, PARP inhibitors) will be considered as part of the preceding line of therapy (i.e., not counted independently)
- •Patients must be willing to provide an archival tumor tissue block or slides, or fresh biopsy collected using a non-significant risk procedure.
- •Patients must meet threshold of FRa positivity criteria by the Ventana IHC test.
- •Female patients = 18 years of age with Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- •Patients must have adequate hematologic, liver, cardiac, and kidney function.
- •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 133
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
排除标准
- •Patients with clear cell, mucinous or sarcomatous histology, or low grade ovarian cancer
- •Patients with primary platinum-refractory disease as defined by those who progressed during or within four weeks of completion of first platinum-based chemotherapy (Friedlander 2011)
- •Patients with prior wide-field radiotherapy affecting at least 20% of the bone marrow
- •Patients with uncontrolled bleeding disorders or inadequate coagulation parameters
- •Patients with > Grade 1 peripheral neuropathy
- •Patients with active or chronic ocular disorders
- •History of neurological conditions, or concurrent neurological condition that would confound assessment of treatment-emergent neuropathy
- •History of hemorrhagic or ischemic stroke within the prior six months
- •Women who are pregnant or lactating or women of childbearing potential (WCBP) not protected by highly-effective contraceptive methods
研究者
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