EUCTR2017-003413-25-BE进行中（未招募）1 期
A single arm, multicenter, international trial of tisotumab vedotin (HuMax®-TF-ADC) in previously treated, recurrent or metastatic cervical cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Genmab A/S
- 入组人数
- 100
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 with extra-pelvic metastatic or recurrent cervical cancer including squamous cell, adenocarcinoma or adenosquamous histology, that:
- •1. Have experienced disease progression during or after treatment with:
- •- Paclitaxel+cisplatin or carboplatin OR
- •- Paclitaxel+topotecan,
- •in combination with bevacizumab unless patients are ineligible for bevacizumab treatment according to local standards.
- •2. Have received no more than 2 prior systemic treatment regimens for recurrent or metastatic cervical cancer. Chemotherapy administered in the adjuvant or neoadjuvant setting,or in combination with radiation therapy should not be counted as a prior systemic treatment regimen.
- •3. Are not candidates for curative therapy, including but not limited to, radiotherapy or exenterative surgery.
- •Age = 18 years
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Life expectancy of at least three months
- •A negative serum pregnancy test for patients of reproductive potential
- •Patients of reproductive potential must agree to use adequate contraception during and for 6 months after the last IMP administration
- •Following receipt of verbal and written information about the trial, patients must provide signed informed consent before any trial-related activity is carried out
- •Acceptable coagulation status:
- •- For patients not on anti-coagulation therapy:
- •o International normalized ratio (INR) = 1.2
- •o Activated partial thromboplastin time (aPTT) = 1.25 ULN.
- •- For patients on anti-coagulation therapy:
- •o aPTT = 1.25 ULN.
- •* Patients on anti-coagulants that require laboratory assessments for dose titration (warfarin or other Vitamin K dependent anti-coagulant agents) must be on a steady dose (no active titration) for 4 weeks prior to first planned administration of tisotumab vedotin and have an INR = 2.5 for eligibility.
- •* Patients on anti-coagulants that do not require laboratory assessments for dose titration do not to be on a steady dose >4 weeks prior to first planned administration of tisotumab vedotin.
- •o Concurrent chronic use of prophylactic AcetylSalicylic Acid (ASA, e.g., aspirin) is prohibited on any type of anti-coagulation 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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •Known past or current coagulation defects
- •Ongoing major bleeding
- •Clinically significant cardiac disease
- •Other cancer: Known past or current malignancy other than inclusion diagnosis
研究者
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